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Draft D e cision Guidance Document Me rcury Rotterdam Convention Operation of the prior informed consent procedure for banned or severely restricted chemicals IMPORT S:\\Marin\\Agenda\\!OLEGENE.WPG INCLUDEPICTURE "S:\\Marin\\Agenda\\!OLEGENE.WPG" \* MERGEFORMATINET IMPORT S:\\Marin\\Agenda\\!UNEP.WPG INCLUDEPICTURE "S:\\Marin\\Agenda\\!UNEP.WPG" \* MERGEFORMATINET Secretariat of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade Table of Contents TOC \o "1-2" \h \z \u Table of Contents PAGEREF _Toc154010803 \h 2 Introduction PAGEREF _Toc154010804 \h 3 Standard core set of abbreviations PAGEREF _Toc154010805 \h 5 1. Identification and uses (see Annex 1 for further details) PAGEREF _Toc154010806 \h 7 2. Reasons for inclusion in the PIC procedure PAGEREF _Toc154010807 \h 8 2.1 Final regulatory action (see Annex 2 for further details) PAGEREF _Toc154010808 \h 8 2.2 Risk evaluation (see Annex 1 for further details) PAGEREF _Toc154010809 \h 8 3. Protective measures that have been applied concerning the chemical PAGEREF _Toc154010810 \h 10 3.1 Regulatory measures to reduce exposure PAGEREF _Toc154010811 \h 10 3.2 Other measures to reduce exposure PAGEREF _Toc154010812 \h 11 3.3 Alternatives PAGEREF _Toc154010813 \h 11 3.4 Socio-economic effects PAGEREF _Toc154010814 \h 11 4. Hazards and risks to human health and the environment PAGEREF _Toc154010815 \h 12 4.1 Hazard Classification PAGEREF _Toc154010816 \h 12 4.2 Exposure limits PAGEREF _Toc154010817 \h 12 4.3 Packaging and labelling PAGEREF _Toc154010818 \h 13 4.4 First aid PAGEREF _Toc154010819 \h 13 4.5 Waste management PAGEREF _Toc154010820 \h 14 Annex 1: Further information on the substance PAGEREF _Toc154010821 \h 15 1. Physico-chemical properties PAGEREF _Toc154010822 \h 15 2. Toxicological properties PAGEREF _Toc154010823 \h 15 3. Human exposure/risk evaluation PAGEREF _Toc154010824 \h 20 4. Environmental fate and effects PAGEREF _Toc154010825 \h 22 5. Environmental exposure/risk evaluation PAGEREF _Toc154010826 \h 23 Annex 2: Details on final regulatory actions reported PAGEREF _Toc154010827 \h 25 Annex 3: Addresses of designated national authorities PAGEREF _Toc154010828 \h 31 Annex 4: References PAGEREF _Toc154010829 \h 32 1. Regulatory actions PAGEREF _Toc154010830 \h 32 2. Supporting Documentation PAGEREF _Toc154010831 \h 32 3. Other Documents PAGEREF _Toc154010832 \h 32 Introduction The objective of the Rotterdam Convention is to promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use, by facilitating information exchange about their characteristics, by providing for a national decision-making process on their import and export and by disseminating these decisions to Parties. The Secretariat of the Convention is provided jointly by the United Nations Environment Programme (UNEP) and the Food and Agriculture Organization of the United Nations (FAO). Candidate chemicals for inclusion in the prior informed consent ( PIC ) procedure under the Rotterdam Convention include those that have been banned or severely restricted by national regulatory actions in two or more Parties in two different regions. Inclusion of a chemical in the PIC procedure is based on regulatory actions taken by Parties that have addressed the risks associated with the chemical by banning or severely restricting it. Other ways might be available to control or reduce such risks. Inclusion does not, however, imply that all Parties to the Convention have banned or severely restricted the chemical. For each chemical included in Annex III of the Rotterdam Convention and subject to the PIC procedure, Parties are requested to make an informed decision whether they consent or not to the future import of the chemical. At its […] meeting, held in […] on […], the Conference of the Parties agreed to list [chemical name] in Annex III of the Convention and adopted the decision-guidance document with the effect that this group of chemicals became subject to the PIC procedure. The present decision-guidance document was communicated to designated national authorities on […], in accordance with Articles 7 and 10 of the Rotterdam Convention. Purpose of the decision guidance document For each chemical included in Annex III of the Rotterdam Convention, a decision-guidance document has been approved by the Conference of the Parties. Decision-guidance documents are sent to all Parties with a request that they make a decision regarding future import of the chemical. Decision-guidance documents are prepared by the Chemical Review Committee. The Committee is a group of government-designated experts established in line with Article 18 of the Convention, which evaluates candidate chemicals for possible inclusion in Annex III of the Convention. Decision-guidance documents reflect the information provided by two or more Parties in support of their national regulatory actions to ban or severely restrict the chemical. They are not intended as the only source of information on a chemical nor are they updated or revised following their adoption by the Conference of the Parties. There may be additional Parties that have taken regulatory actions to ban or severely restrict the chemical and others that have not banned or severely restricted it. Risk evaluations or information on alternative risk mitigation measures submitted by such Parties may be found on the Rotterdam Convention website (www.pic.int). Under Article 14 of the Convention, Parties can exchange scientific, technical, economic and legal information concerning the chemicals under the scope of the Convention including toxicological, ecotoxicological and safety information. This information may be provided directly to other Parties or through the Secretariat. Information provided to the Secretariat will be posted on the Rotterdam Convention website. Information on the chemical may also be available from other sources. Disclaimer The use of trade names in the present document is primarily intended to facilitate the correct identification of the chemical. It is not intended to imply any approval or disapproval of any particular company . As it is not possible to include all trade names presently in use, only a number of commonly used and published trade names have been included in the document. While the information provided is believed to be accurate according to data available at the time of preparation of the present decision-guidance document, FAO and UNEP disclaim any responsibility for omissions or any consequences that may arise there from. Neither FAO nor UNEP shall be liable for any injury, loss, damage or prejudice of any kind that may be suffered as a result of importing or prohibiting the import of this chemical. The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of FAO or UNEP concerning the legal status of any country, territory, city or area or of its authorities or concerning the delimitation of its frontiers or boundaries. Standard core set of abbreviations &lt; L ess than &lt; L ess than or equal to &gt; G reater than &gt; G reater than or equal to µg M icrogram m M icrometre A R fD A cute reference dose a.i. A ctive ingredient ADI A cceptable daily intake AOEL A cceptable operator exposure level b.p. B oiling point bw B ody weight o C D egree Celsius (centigrade) CAS Chemical Abstracts Service cc C ubic centimetre cm C entimetre DNA D eoxyribose nucleic acid DT 50 D issipation time 50% EC 50 M edian effective concentration ED 50 M edian effective dose ECHA EEC European Chemicals Agency European Economic Community EHC E nvironmental H ealth C riteria EU European Union FAO Food and Agriculture Organization of the United Nations g G ram h H our ha H ectare i.m . I ntramuscular i.p. I ntraperitoneal IARC International Agency for Research on Cancer IC 50 M edian inhibitory concentration ILO International Labour Organization IPCS International Programme on Chemical Safety IPM Integrated Pest Management IUPAC International Union of Pure and Applied Chemistry JMPR Joint FAO/WHO Meeting on Pesticide Residues (Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and a WHO Expert Group on Pesticide Residues) kg K ilogram K oc S oil organic partition coefficient. Kow O ctanol–water partition coefficient kPa K ilopascal L L itre LC 50 M edian lethal concentration LD 50 M edian lethal dose LOAEL lowest - observed - adverse - effect level LOEL Lowest - observed - effect level m M etre m.p. M elting point mg M illigram ml M illilitre mPa M illipascal MRL M aximum residue limit MTD M aximum T olerated D ose ng N anogram NOAEC N o-observed-adverse-effect concentration NOAEL N o-observed-adverse-effect level NOEC N o-observed-effect concentration NOEL N o-observed-effect level OECD Organisation for Economic Co-operation and Development PEC P redicted environmental concentration Pow O ctanol-water partition coefficient , also referred to as Kow PPE P ersonal protective equipment ppm P arts per million (used only with reference to the concentration of a pesticide in an experimental diet. In all other contexts the terms mg/kg or mg/ L are used). RfD R eference dose ( for chronic oral exposure ; comparable to ADI ) SMR S tandard ( ized ) mortality ratio STEL S hort - term exposure limit TER Toxicity exposure ratio TLV T hreshold limit value TWA T ime - weighted average UNEP United Nations Environment Programme USEPA United States Environmental Protection Agency UV U ltraviolet VOC V olatile organic compound w/w Weight for weight WHO World Health Organization w t W eight Decision guidance document for a banned or severely restricted chemical Mercury Published: 1. Identification and uses (see Annex 1 for further details) Common name Mercury Chemical name and other names or synonyms Mercury Molecular formula Hg Chemical structure Hg CAS No. 7439-97-6 Harmonized System Customs Code 2805.40 Other numbers EC number 231-106-7 Category Industrial Regulated category Industrial Use(s) in regulated category In Colombia, mercury was used in mining, chlor-alkali industry, production of fluorescent lamps and in the manufacture of dental amalgams. The final regulatory action prohibited the marketing and use of mercury in the different industrial activities on July 15, 2013 , the use of mercury in mining activities from July 15, 2018, and all other industrial activities including the manufacture of dental amalgams from July 15, 2023. In the European Union, mercury was used in mining, chlor-alkali industry, the production of lamps, electrical and electronic devices. The final regulatory action notified by the European Union severely restricts the industrial use of mercury in several sectors through different Directives and Regulations. The Minamata Convention on Mercury aims to protect human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds . The Convention addresses all aspects of the life cycle of mercury , including: the direct mining of mercury, its export and import, its safe storage and its disposal once it becomes waste , the r educ tion and where feasible the eliminat ion of the use and release of mercury from artisanal and small-scale gold mining , the c ontrol of mercury air emissions from coal-fired power plants, coal-fired industrial boilers, certain non-ferrous metals production operations, waste incineration and cement production , the p hase-out or reduc tion of mercury use in certain products such as batteries, switches, lights, cosmetics, pesticides and measuring devices, and creat ing initiatives to reduce the use of mercury in dental amalgam , and the p hase out or reduc tion of the use of mercury in manufacturing processes such as chlor-alkali production, vinyl chloride monomer production, and acetaldehyde production Trade names Colloidal mercury, Quicksil v er, Liquid silver, Hydrargyrum . This is an indicative list. It is not intended to be exhaustive. Formulation types Elemental Mercury Uses in other categories Use as a chemical intermediate in the manufacture of various industrial chemicals and processes (UNEP 2017) . Basic manufacturers Avantor, Inc. ( Thermo Fisher Scientific), AHSA, Aldrett Hermanos SA de CV., Merck KGaA . This is an indicative list of current and former manufacturers. It is not intended to be exhaustive. 2. Reasons for inclusion in the PIC procedure Me rcury is included in the PIC procedure as a n industrial chemical . It has been listed on the basis of the final regulatory actions to severely restrict its use, notified by Colombia and the European Union . Contact details of the designated national authorities of these two Parties are set out in annex 3 to the decision guidance document. 2.1 Final regulatory action (see Annex 2 for further details) Colombia Based on Law 1658 of 15 July 2013, the government of Colombia prohibited the marketing and use of mercury. The regulation eradicates the use of mercury in the national territory in: 1) all industrial and production processes within a period not exceeding 10 years ( until 15 July 2023), and 2) for mining within a maximum period of 5 years ( until 15 July 2018). T he deadline for industrial uses other than mining has not been met; this is the reason why the use of mercury in the production of dental amalgam will continue d until 15 July 2023. Reason: Human Health and Environment European Union The use of mercury as an industrial chemical is severely restricted in the European Union pursuant to Regulation (EU) 2017/852 on mercury, Regulation (EC) 1907/2006 (REACH), Directive 2011/65/EU (RoHS) and Directive 2006/66/EC (batteries and accumulators). More specifically: In 2006, Directive 2006/66/EC introduced a prohibition on the placing on the market of batteries and accumulators containing mercury; In 2007, Directive 2007/51/EC introduced a restriction under Directive 76/769/EEC on the placing on the market of mercury in fever thermometers and in other measuring devices intended for sale to the general public; Regulation (EC) No 1907/2006 (REACH) repealed Directive 76/769/EEC. Commission Regulation (EC) No 552/2009 amended Annex XVII to REACH by incorporating in entry 18.a the restrictions on certain measuring devices containing mercury that was adopted under Directive 2007/51/ EC; In 2011, Directive 2011/65/EU (RoHS) established a restriction on the placing on the market of electric and electronic equipment to a maximum concentration value of 0.1% of mercury, allowing exemptions for certain applications for a limited time period; Commission Regulation (EU) No 847/2012 amended Annex XVII to REACH by incorporating in entry 18.a. a restriction on the placing on the market of mercury-containing and mercury- using measuring devices intended for industrial and professional uses. The restriction started to apply from 10 April 2014 . Regulation (EU) 2017/852 on mercury was adopted in May 2017. This regulation complements the European Union acquis and lays down the provisions that are needed to ensure the complete alignment of the European Union acquis with the Minamata Convention on Mercury establishing measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste. Reason: Human Health and Environment 2.2 Risk evaluation (see Annex 1 for further details) Colombia According to the evaluation related to human health and the environment, the following information was identified: The data includes extensive neuro-epidemiological studies in exposed populations (occupational and general population) and studies in different environmental compartments (freshwater, soil, sediment, biota, etc.), food (fish), with a view of establishing the levels of mercury and the perception of risk, and generating scientific, regulatory and technical evidence on the mercury problem both at the national and international level of the health sector and other related sector s . Mercury measurements have been made in humans, mainly in workers and communities surrounding mining activities or adjacent to riverine areas ; The evaluation conducted establish that mercury is a toxic substance, that when entering the human body produces disorders, mainly at the central nervous system level. The presence of mercury in the air, water, soil and food (mainly fish) in concentrations above the allowed limit has caused a serious public health problem in Colombia. Regions such as the Northeast of Antioquia, the South of Bolívar, Chocó, Santander, Nariño, Caldas, Vaupés, among others, carry out artisanal gold mining and for the final extraction of this precious metal, mercury is used. Its use occurs in an indiscriminate and poorly controlled way, a situation that has caused environmental contamination and has affected people's health. Exposure to mercury is also increased in industrial areas that use this substance ; Studies conducted by the Government of Antioquia in the municipalities of Segovia and Remedios, in the Northeast of the department, found a concentration of mercury of approximately 340 μg /m³ in the air (300 times higher than the guideline of the World Health Organization for public maximum exposure to vapour of mercury). Approximately 26 to 6,118 ppm of Hg is discharged into rivers by miners in the region. Additionally, the main food of these communities is fish, which has been shown to be affected by the emission of mercury. Studies completed by Corantioquia , the University of Antioquia, and the University of Cartagena have revealed a concentration above 1.06 μg Hg/g in most of the species found in the rivers of the surrounding area ; Mercury contamination in Colombia was originated in the gold benefit processes in which the mineral containing the precious metal is extracted by joining with the mercury, forming the amalgam. During the process, mercury spills into water bodies and the environment. Subsequently, the amalgam obtained is burned in the open air, leaving the gold and releasing the toxic mercury vapour s into the atmosphere. All these activities are performed very close to the miners' households, in such a way that families breathe a large part of the volatilized mercury vapour. Even remote populations can be affected by the mobilization of this substance (Protocol for Surveillance and Control of Acute Mercury Poisoning ) ; Studies carried out in exposed populations (occupational and general population) to mercury have made it possible to establish its relationship in the development of the observed manifestations (Fawer et al 1983, Piikivi 1989, Marh et al 1987). The neuroepidemiological and toxicological study of the Suratá river pollutants carried out in the mining population of that region (Santander, 1992) raised the possible relationship of chronic exposure to mercury with the presence of neurological diseases. Tirado et al (2000) suggest that this form of exposure can cause neuropsychological and behavioural deficits in the population. In 1995, Olivero et al reported that the inhabitants of southern Bolívar presented signs of mercury intoxication such as hand tremors, neurological disorders and visual problems, among others. In this region, frequent cases of congenital malformations have also been reported, although without evidence of association with mercury exposure ; According to National Public Health Surveillance System - SIVIGILA, during 2010 and in the first half of 2011, 201 cases of mercury poisoning were reported in Colombia- 96% of the cases were of occupational or accidental origin as follows: 85% (n = 171) occupational, 11% (n = 22) accidental ; Occupational exposure is the most frequent in the reported cases, where mining and quarrying occupations are the ones with the highest number of cases associated with the use of mercury as an input for gold mining. The most significant conclusions indicate that the most frequent notifiers during the period were Antioquia, followed by Bogotá, Bolívar, Risaralda, Santander and Valle del Cauca. The highest percentage of intoxications reported were occupational, been respiratory the most frequent route of exposure, and according to the analysis by occupation, the highest number of intoxicated were miners or stonemasons (Scientific, Regulatory and Technical Evidence on the Mercury Problem at the Level National and International Health Sector and Other Related Sectors ) ; It was identified that there are some population groups that deserve special attention in relation to exposure to mercury, since they have a greater probability of exposure to dangerous levels, or because carriers of disease, the intoxication effects can be exacerbated: Workers exposed to mercury; General population next to sources of mercury contamination (mines, industries); Populations in areas contaminated by mercury, especially indigenous and riverine, whose main source of proteins is fish; People using mercury-containing medications for a long time; People with central nervous system diseases, patients with chronic kidney and bronco pulmonary failure; Pregnant women and toddlers . European Union According to the evaluation related to human health and the environment, the following information was identified: While this risk assessment was conducted in the context of the restriction on mercury-containing measuring devices intended for industrial and professional uses, it includes information on the risks associated with mercury that is not limited to those measuring devices and that could support the other Directives and Regulations that comprise the final regulatory action notified by the European Union. According to the ECHA Committee for Risk Assessment ( RAC ) O pinion and its background document, mercury and its compounds are highly toxic to humans, ecosystems and wildlife, with amongst others serious chronic irreversible adverse neurotoxic and neurodevelopmental effects. The RAC opinion includes a PBT assessment for mercury-methylmercury concluding an equivalent level of concern in terms of persistency, due to mercury cycling and methylation versus demethylation rates under anaerobic conditions, as well as the clear potential for bioaccumulation and toxicity identified for methylmercury . The hazard and fate of mercury and its compounds are described in numerous peer-reviewed reports, which were referenced in the Document ation provided: ‘Global Mercury Assessment’, published by UNEP in 2002 (and UNEP 2008a and b); ‘Methylmercury’ (WHO, 1990); ‘Risks to Health and the Environment Related to the Use of Mercury Products’ prepared for the Commission by RPA in 2002. It is estimated that 3.5–7.6 tonnes of mercury are placed on the market in mercury containing measuring devices in 2010. These amounts are used to estimate the maximum potential for mercury emissions to the environment that might ultimately occur. This assumption is considered appropriate because of an estimated low separate collection rate of mercury waste and resulting inadequate waste treatment of a substantial part of the devices. This inappropriate waste collection leads in the long term to a relatively high share of mercury used in these devices being released to the environment. For measuring equipment using mercury (porosimeters, mercury probes used for capacitance-voltage determinations and mercury electrodes used in voltammeters) the total use is 5–15 tonnes per year (mostly porosimeters 5–14 tonnes per year). It should be noted that these figures are the amount of mercury the laboratories purchase and cannot be used to estimate maximum potential for emission as is the case for the measuring equipment containing mercury. To estimate emissions several additional factors need to be considered. These include number of measurements carried out, practices to purify and regenerated used mercury and the risk management measures and operational conditions applied to control the emissions and exposures . The total mercury consumption in Europe was in 2007 estimated to be 320–530 tonnes. 160–190 tonnes of the total amount were used in the chlor-alkali production and 90–110 were used in dental amalgams. The amount used in mercury measuring devices thus equals about 4% of the total, while the restricted devices will be lower due to the large use in porosimeters . Once released to the environment, mercury persists in the environment, where it circulates between air, water, sediments, soil and biota in various forms. Mercury can be transformed to methylmercury, the most toxic form, which biomagnifies especially in the aquatic food chain, making populations and wildlife with a high intake of fish and seafood particularly vulnerable . Several existing pieces of legislation in the European Union abate the risks arising from mercury in different stages of the life cycle of measuring devices. However, none of the measures currently in place is sufficient to remove the concern fully, although there is a difference between their observed effectiveness with regard to measuring devices containing mercury and measuring devices using mercury . The emissions from mercury measuring devices, although relatively small, contribute to the overall emissions of mercury to the environment and thereby also to the exposure of species and of humans via the environment. Therefore, measuring devices containing or using mercury are of concern . 3 . Protective measures that have been applied concerning the chemical 3 . 1 Regulatory measures to reduce exposure Colombia The government of Colombia prohibited the marketing and use of mercury in the different industrial activities under Law 1658 on July 15, 2013, the use of mercury in mining activities from 15 July 2018, and all other industrial activities including the manufacture of dental amalgams from 15 July 2023 . European Union The final regulatory action notified by the European Union severely restricts the industrial use of mercury in several sectors through different Directives and Regulations. More specifically: In 2006, Directive 2006/66/EC introduced a prohibition on the placing on the market of batteries and accumulators containing mercury; In 2007, Directive 2007/51/EC introduced a restriction under Directive 76/769/EEC on the placing on the market of mercury in fever thermometers and in other measuring devices intended for sale to the general public; Regulation (EC) No 1907/2006 (REACH) repealed Directive 76/769/EEC. Commission Regulation (EC) No 552/2009 amended Annex XVII to REACH by incorporating in entry 18.a the restrictions on certain measuring devices containing mercury that was adopted under Directive 2007/51/EC; In 2011, Directive 2011/65/EU (RoHS) established a restriction on the placing on the market of electric and electronic equipment to a maximum concentration value of 0.1% of mercury, allowing exemptions for certain applications for a limited time period; Commission Regulation (EU) No 847/2012 amended Annex XVII to REACH by incorporating in entry 18.a. a restriction on the placing on the market of mercury-containing and mercury- using measuring devices intended for industrial and professional uses. The restriction started to apply from 10 April 2014 . Regulation (EU) 2017/852 on mercury was adopted in May 2017. This regulation complements the European Union acquis and lays down the provisions that are needed to ensure the complete alignment of the European Union acquis with the Minamata Convention on Mercury establishing measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste. 3 . 2 Other measures to reduce exposure Colombia None reported. European Union None reported. 3 . 3 Alternatives Colombia N o information was provided . European Union No information was provided . General The Minamata Convention on Mercury addresses all aspects of the life cycle of mercury, including requiring controls and reductions across a range of products, processes and industries. Updated information on the phase out of products containing mercury and available alternatives to these products , including alternatives to the use of mercury in manufacturing processes and mining is available on the Convention’s website at https://minamataconvention.org 3 . 4 Socio-economic effects Colombia No assessment of socio-economic effects was reported . European Union No assessment of socio-economic effects was reported . 4 . Hazards and r isks to human health and the environment 1 4 . 1 Hazard Classification WHO / IPCS Mercuric chloride, Class Ib Mercuric oxide, Class Ib Mercurous chloride, Class II IARC Group 3 ( not classifiable as to their carcinogenicity to humans ) Methylmercury, Group 2B (possibly carcinogenic to humans) European Union Acute Tox 2 : H330 - f atal if inhaled. STOT RE 1: H372 – causes damage to organs through prolonged or repeated exposure . Aquatic Acute 1 : H400 – very toxic to aquatic l ife. Aquatic Chronic 1: H410 – very toxic to aquatic life with long lasting effects. Repr . 1B: H360D – may damage the unborn child. US EPA Carcinogenicity classification : Mercury, elemental D ( IRIS 1995 a) Mercuric chloride C ( IRIS 1995 b) Methylmercury C (IRIS2001) 1 : E lemental mercury is ionized and methylized in the environment and therefore this chapter includes information on hazard, exposure and risk of mercury compounds. 4 . 2 Exposure limits WHO (20 21 ) In 2003 the Joint FAO/WHO Expert Committee on Food Additives (JECFA) established a tolerable intake of 1.6 µg/kg body weight per week for dietary exposure to methylmercury in order to protect the developing foetus from neurotoxic effects. In 2006, JECFA clarified that life stages other than the embryo and foetus may be less sensitive to the adverse effects of methylmercury. For adults, up to about twice the tolerable intake per week would not pose any risk of neurotoxicity. However, available data did not allow firm conclusions to be drawn for children (aged up to about 17 years), as they may be more sensitive than adults. Hence the tolerable intake established in 2003 applies also to children. In 2010 JECFA established a provisional tolerable weekly intake for inorganic mercury of 4 μg /kg body weight, applicable to dietary exposure to total mercury from foods other than fish and shellfish . Drinking w ater: 6 µg/litre for inorganic mercury. Air: 1 µg/m3 (annual average). WHO estimated a tolerable concentration of 0.2 µg/m3 for long-term inhalation exposure to elemental mercury vapour, and a tolerable intake of total mercury of 2 µg/kg body weight per day (17). SCOEL/ SUM / 84 (2007) Occupational exposure: 8-hour T otal W eight A verage (TWA) : 0.02 mg mercury/m 3 Biological limit values (BLV): 10 µg Hg/l blood; 30 µg Hg/g creatinine in urine 4 . 3 Packaging and labelling The United Nations Committee of Experts on the Transportation of Dangerous Goods classifies the chemical in: Hazard Class and Packing Group: UN Hazard Class: 8 UN subsidiary risk: 6.1 UN pack Group III Source: ICSC 0056 - MERCURY (inchem.org) UN shipping names ADR/RID/IMDG : MERCURY International Maritime Dangerous Goods (IMDG) Code According to UN GHS Criteria INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/acid_red.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/acid_red.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/skull.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/skull.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/silhouete.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/silhouete.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/aquatic-pollut-red.gif" \* MERGEFORMATINET INCLUDEPICTURE "http://www.ilo.org/webcommon/dyn/images/icsc/ghs-pictograms/aquatic-pollut-red.gif" \* MERGEFORMATINET DANGER May be corrosive to metals Fatal if inhaled May damage fertility or the unborn child Causes damage to central nervous system and kidneys Causes damage to the central nervous system and the kidneys through prolonged or repeated exposure Very toxic to aquatic life with long lasting effects Transport Emergency Card ICSC 0056 - MERCURY (inchem.org) 4 . 4 First aid NOTE: The following advice is based on information available from the World Health Organisation and the notifying countries and was correct at the time of publication. This advice is provided for information only and is not intended to supersede any national first aid protocols. International Chemical Safety Cards (ICSCs): ICSC 0056 - MERCURY (inchem.org) Description of first aid measures AVOID ALL CONTACT! IN ALL CASES CONSULT A DOCTOR! SYMPTOMS PREVENTION FIRST AID Inhalation Cough. Sore throat. Shortness of breath. Fever. Vomiting. Diarrhoea. Abdominal pain. Headache. Weakness. Use local exhaust or breathing protection. Fresh air, rest. Artificial respiration may be needed. Refer immediately for medical attention. Skin MAY BE ABSORBED! Redness. Protective gloves. Protective clothing. Remove contaminated clothes. See Notes. Rinse and then wash skin with water and soap. Refer for medical attention. Eyes Wear face shield or eye protection in combination with breathing protection. First rinse with plenty of water for several minutes (remove contact lenses if easily possible), then refer for medical attention. Ingestion Do not eat, drink, or smoke during work. Wash hands before eating. Refer for medical attention. Fire- f ighting m easures In case of fire in the surroundings, use appropriate extinguishing media. In case of fire: keep drums, etc., cool by spraying with water. Spillage disposal Evacuate danger area! Consult an expert! Personal protection: chemical protection suit and filter respirator for mercury adapted to the airborne concentration of the substance. Ventilation. D O NOT let this chemical enter the environment. Collect leaking and spilled liquid in sealable non-metallic containers as far as possible. Then store and dispose of according to local regulations. Storage Provision to contain effluent from fire extinguishing. Separated from food and feedstuffs. Well closed. Store in an area without drain or sewer access . 4 . 5 Waste management Regulation (EU) 2017/852 on mercury was adopted in May 2017. This regulation complements the European Union acquis and lays down the provisions that are needed to ensure the complete alignment of the European Union acquis with the Minamata Convention on Mercury establishing measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste. Basel Technical guidelines on the environmentally sound management of wastes consisting of, containing or contaminated with mercury or mercury compounds are available - Adopted by COP-15, June 202 2 ( Technical guidelines ). Annexes Annex 1 : Further information on the substance Annex 2 : Details on f inal regulatory action Annex 3 : Address of designated national authorities Annex 4 : References Annex 1 : Further information on the substance The information presented in this annex reflects the conclusions of the notifying Parties: Colombia and the European Union . The notification from Colombia was published in PIC Circular LII of December 2020. The notification from the European Union was published in PIC Circular L V I of December 20 2 2. This information has been taken from the notifications of the final regulatory actions to ban mercury and the supporting documents. The toxicity of mercury is very well documented internationally and only a brief summary of data to supplement information provided in the notifications is included in this annex . This annex is not meant to be a comprehensive review of the toxicological profile of mercury. More detailed information is available in the following UNEP Mercury Assessments: Global Mercury Assessment 2002 ; The Global Atmospheric Mercury Atmospheric Assessment 2008 : Sour c e s , Emissions and Transport ; Global Mercury Assessment 2013: Sources, emissions, releases, and environmental transport ; Global Mercury Assessment 2018 . The global lifecycle of mercury is addressed under the Minamata Convention on Mercury. 1. Physico -chemical properties 1.1 Identity Mercury 1.2 Formula Hg 1.3 Mol e cular weight 200.6 g/mol 1.4 Colour and Texture Silver-white liquid at room temperature 1. 5 Melting point Melting point: -39 C (at 101 325 Pa) 1.6 Boiling point Boiling point: 357 C (at 101 325 Pa) 1. 7 Density 13 . 5 g/cm 3 at 25 C 1.8 Solubility in water none 1. 9 Vapour density (air=1) 6.93 1.10 Vapour pressure 0.26 Pa at 20C 1. 11 Viscosity 1.55 mPa s at 20 C 1. 12 Relative density vapour /air-mixture 1.009 (ait=1) at 20 C 2 . Toxicological properties 2.1 General European Union Mercury is a chemical of global concern owing to its long-range atmospheric transport, its persistence in the environment once anthropogenically introduced, its ability to bioaccumulate in ecosystems and its significant negative effects on human health, which include significant adverse neurological and other health effects, with particular concerns expressed about its harmful effects on infants and unborn children. Mercury can be transformed to methylmercury, the most toxic form, which biomagnifies especially in the aquatic food chain, making populations and wildlife with a high intake of fish and seafood . 2.1.1 Mode of Action European Union Elemental mercury is very toxic to humans via inhalation. About 80 percent of inhaled vapours are absorbed by the lung tissues. This vapour easily penetrates the blood-brain barrier and is a well documented neurotoxicant causing neurological and behavioural disorders in humans when inhaled. Specific symptoms include tremors, emotional lability, insomnia, memory loss, neuromuscular changes, and headaches. Intestinal absorption of elemental mercury is low . WHO (2003) At high levels of exposure, elemental mercury induces adverse effects in most organ systems in the body. Respiratory failure, cardiac arrest, and cerebral oedema are the causes of death in fatal cases. The central nervous system is the most sensitive target for elemental mercury vapour exposure. Similar effects are seen following all durations of exposure, but their severity increases as exposure duration and/or concentration increase. Long-term exposure to elemental mercury may lead to changes in renal function . 2.1.2 Symptoms of poisoning WHO (2003) Prominent symptoms include tremors, emotional lability, insomnia, memory loss, neuromuscular changes, headaches, polyneuropathy, and performance deficits in tests of cognitive or motor function. 2.1.3 Absorption, distribution, excretion and metabolism in mammals WHO (2003) Inhalation is the primary route of entry into the body for elemental mercury, while oral exposure is the primary route for inorganic mercury salts. Dermal penetration is usually not a significant route of exposure to inorganic mercury. Approximately 80% of inhaled elemental mercury is absorbed through the lungs by rapid diffusion. In contrast, only 0.01% of elemental mercury is absorbed through the gastrointestinal tract, possibly because of its enterogastric conversion to divalent mercury and subsequent binding to sulfhydryl groups. Dermal absorption of elemental mercury is limited. D ermal absorption is estimated to contribute approximately 2.6% of the absorbed mercury following exposure to elemental mercury vapour in the air; the other 97.4% occurs through inhalation. T he absorption, blood levels, and excretion of mercury evaluated in nine healthy volunteers (two males, seven females) exposed to mercury vapour in air at 400 µg/m3 for 15 min corresponded to a dose of 5.5 nmol mercury/kg body weight. Samples of exhaled air, blood, and urine were collected for 30 days after exposure. The median retention of elemental mercury after 30 days was 69% of the inhaled dose. This corresponds to the estimated half-life of approximately 60 days for elemental mercury . The lipophilic nature of elemental mercury results in its distribution throughout the body. Elemental mercury dissolves in the blood upon inhalation, and some remains unchanged. Elemental mercury in the blood is oxidized to its divalent form in the red blood cells. The divalent cation exists as a diffusible or non-diffusible form. The non-diffusible form exists as mercuric ions that bind to protein and are held in high-molecular-weight complexes, existing in equilibrium with the diffusible form. In the plasma, the mercuric ion is predominantly non-diffusible and binds to albumin and globulins . The high lipophilicity of elemental mercury in solution in the body allows it to readily cross the blood– brain and placental barriers. In mice, the uptake of mercury across the placenta appears to increase as gestation progresses. Levels of mercury in the f o etus are approximately 4 times higher after exposure to elemental mercury vapour than after mercuric chloride administration for mice and 10– 40 times higher for rats. The transport of the mercuric ion is limited at the placental barrier by the presence of high-affinity binding sites. Mercury distributes to all tissues and reaches peak levels within 24 h, except in the brain, where peak levels are achieved within 23 days . The longest retention of mercury after inhalation of mercury vapour occurs in the brain. Japanese workers who died 10 years after their last exposure to elemental mercury vapours still had high residual levels of mercury in their brains. While the primary organs of mercury deposition following inhalation exposure to elemental mercury vapours are the brain and kidney, the extent of deposition is dependent upon the duration of exposure and, to a greater extent, the concentration to which the organism is exposed. The available evidence indicates that the metabolism of all forms of inorganic mercury is similar for humans and laboratory mammals. Once absorbed, elemental and inorganic mercury enter an oxidation– reduction cycle. Elemental mercury is oxidized to the divalent inorganic cation in the red blood cells and lungs. Evidence from animal studies suggests the liver as an additional site of oxidation. Absorbed divalent cation from exposure to mercuric mercury compounds can, in turn, be reduced to the metallic or monovalent form and released as exhaled elemental mercury vapour. Elimination of mercury occurs primarily through the urine and faeces, with the expired air, sweat, and saliva contributing to a much lesser extent. 2.2 Toxicology studies ECHA Registration Dossier 5169 2.2.1 Acute toxicity In an acute oral toxicity study in rats of different age groups, the highest oral toxicity was found in the youngest group of rats (two - week-old sucklings ) as indicated by the lowest LD 50 value of 35 mg/kg bw mercury chloride (26 mg Hg/kg bw ). In six - week-old animals, a LD 50 of about 92 mg/kg bw HgCl 2 (78 mg Hg/kg bw ) was determined, and in older animals (up to 54 weeks) the LD 50 values were only about 1.4 times higher than in sucklings (50 mg/kg bw HgCl 2 corresponding to 37 mg Hg/kg bw ). The LD 50 (rats) was higher than 2000 mg/kg for the test item MISCELA HY-TQS. Since only about 24.8% of mercury are included in the test item, this can be recalculated to &gt; 496 mg/kg mercury. A concentration level of 27 mg/m 3 Hg was lethal in the majority of animals exposed by inhalation for 2 hours, but no death occur r ed in animals exposed only for 1 hour. Limited information on acute dermal toxicity in rabbits indicated lethality after application of high dermal doses of mercury from ointments. Mild to moderate morphological changes were observed in the kidneys of rats at lower oral dose levels in the range of 10.0 and 12.5 mg/kg bw (7.4 and 9.2 mg Hg/kg bw /d). Morphological changes in kidneys were also found in animals treated dermally with high doses of mercury. Biochemistry revealed decreased levels of lactate dehydrogenase (LDH) activity and an increase in serum cholesterol and phosphorus, and hematology showed decreases in red blood cell parameters in the oral study. 2.2.2 Short term toxicity ECHA Registration Dossier 5169 Repeated dose toxicity, oral: Data on repeated dose toxicity by the oral route in animals are available. In a NTP study, mice and rats were administered orally by gavage for 2 weeks, 26 weeks or 2 years. The lowest LOAEL of 0.312 mg HgCl 2 /kg bw /d (0.23 mg Hg/kg bw /d) was identified in the 26-week NTP study in rats based on effects on kidney weights and nephropathy. Results from the subsequent 2-year carcinogenicity study in rats revealed the lowest dose level of 2.5 mg/kg bw /d HgCl 2 (1.9 mg Hg/kg bw /d) representing also only a LOAEL based on morphological changes of nephropathy. Repeated dose toxicity, dermal: T here is almost no information available on systemic toxicity resulting from repeated dermal exposure of animals. The evaluation of human literature revealed some information about clinical findings in subjects using skin lightening creams containing mercuric ammonium chloride. It could be concluded that a urinary mercury concentration of 29 µg/l (range 0 -90 µg/l) must be regarded as a LOAEL based on established mercury induced nephrotic syndrom e . However, absorption through the skin is very limited [“... a very small amount of mercury (about 2% of what is taken up by the lungs) enters the body through the skin”], and thus systemic toxicity following repeated dermal exposure appears to be not of major concern. Repeated dose toxicity, inhalation: The biological effects of long-time low to moderate exposures to metallic mercury vapours under occupational settings were evaluated in depth by EuroChlor (2009): It was concluded that with the exception of urinary excretion of N-acetyl-beta-D- glucosamidase (NAG) fr o m the proximal tubular kidney cells , it seems from the review of scientific literature that effects on the central nervous system are the most sensitive indicator of Hg toxicity. It is considered that the toxic effects from high level exposure are sufficiently well known. Sufficient knowledge for defining reasonably tenable occupational exposure limits also seems to be in place. This is based on recent epidemiological studies on cohorts under current or historical low - level exposures. The conclusion of the author of this review, putting a particular emphasis on the latest Ellingsen et al studies encompassing the magnitude of reversibility after cessation or reduction of exposure, there are reasons to support a NOAEL (no adverse effect level) of 30 μg Hg/g creatinine. 2.2.3 Genotoxicity (including mutagenicity) ECHA Registration Dossier 5169 In vitro and in vivo genotoxicity studies showed equivocal results. 2.2.4 Long term toxicity and carcinogenicity ECHA Registration Dossier 5169 The evidence for a mutagenic or carcinogenic potential of Hg in both animal (oral exposure) and epidemiological studies (occupational inhalation exposure) is equivocal, and it is so far lacking in humans at low exposure concentrations &lt; 50 µg/g creatinine in urine. The mutagenic or carcinogenic potential of Hg seems to be related to metal induced oxidative stress and thus, if a potential is present in humans, a threshold effects is hypothetically possible. IARC (1993) Metallic mercury is not classifiable as to its carcinogenicity to humans (Group 3) 2.2.5 Effects on reproduction ECHA Registration Dossier 5169 T oxicokinetic animal data has shown that mercury does penetrate the placental barrier and accumulates in the f o etus when the mother is exposed to metallic Hg vapour. Even though there are inter-species differences, limited epidemiological studies in humans show that there is a transfer from mother to f o etus during Hg vapour exposure. Only a few epidemiological studies have been performed and these were mostly in the field of dentistry. As a whole, the limited data presently available provide no conclusive evidence for occupational exposure to mercury vapour being harmful to reproduction. There is no link to an increase in teratogenic or other adverse pregnancy outcomes . 2.2.6 Neurotoxicity/ delayed neurotoxicity, Special studies where available E uropean Union Methylmercury is highly toxic especially to the nervous system. Methylmercury toxicity has been demonstrated at low exposure levels. In adults, the first effects at the lowest doses are non specific symptoms such as paresthesia , malaise and blurred vision. This may progress to cerebellar ataxia (clumsiness or unsteadiness), dysarthria (speech disorder), constriction of the visual fields and loss of hearing. With increasing exposure there are signs such as construction of the visual field, deafness, dysarthria and ataxia, and ultimately leading to coma and death . Methylmercury exhibits severe neurodevelopmental effects. It passes both the placental barrier and the blood-brain barrier. The developing nervous system in unborn and newborn children is the most sensitive target organ. The effects can take place even at exposure levels where the mother remains healthy or suffers only minor symptoms due to mercury exposure. At lower exposure levels, the effects may only become apparent later during the development as psychomotor and mental impairment and persistent pathological reflexes. In infants exposed to high levels of methylmercury during mothers pregnancy, the clinical picture can be indistinguishable from cerebral palsy caused by other factors, the main pattern being microcephaly, hyperreflexia and gross motor and mental impairment, and in rare cases, blindness or deafness. Some studies suggest even small increases in methylmercury exposures may cause adverse effects on the cardiovascular system, thereby leading to increased mortality. The examples of mercury poisoning in Japan and Iraq have shown on a population scale the severe neurological effects of methylmercury to humans. ECHA Registration Dossier 5169 Marked cellular degeneration and widespread necrosis were observed in the brains of rabbits following exposures to elemental mercury vapour at 28.8 mg/m3 for durations ranging from 2 to 30 h, whereas exposure of rabbits to mercury vapour at 6 mg/m3 for periods ranging from 1 to 11 weeks produced effects ranging from mild, unspecified pathological changes to marked cellular degeneration and some necrosis in the brain. More serious degenerative changes were observed at longer exposure durations (i.e., 8 and 11 weeks). Mild to moderate pathological changes were observed in the brains after exposure to 0.86 mg/m 3 for 12 weeks. S light tremors and clonus were observed in two of six rabbits exposed for 13 weeks to an elemental mercury vapour concentration of 4 mg/m 3 . Neurobehavioural deficits were also observed in the offspring of mother monkeys and rats that were exposed to mercury vapours during gestation . Exposure of neonatal rats to elemental mercury vapour at 0.05 mg/m 3 for 1 or 4 h/day for 1 week during a period of rapid brain growth (postpartum days 11–17) resulted in subtle behavioural changes when the rats were tested at 4 and 6 months of age. The severity of effect was directly related to the duration of individual exposures. 2.2.7 Summary of mammalian toxicity and overall evaluation WHO 2021 Elemental mercury and methylmercury are toxic to the central and peripheral nervous system. The inhalation of mercury vapour can produce harmful effects on the nervous, digestive and immune systems, lungs and kidneys, and may be fatal. The inorganic salts of mercury are corrosive to the skin, eyes and gastrointestinal tract, and may induce kidney toxicity if ingested. Neurological and behavioural disorders may be observed after inhalation, ingestion or dermal application of different mercury compounds. Symptoms include tremors, insomnia, memory loss, neuromuscular effects, headaches and cognitive and motor dysfunction. Mild subclinical signs of central nervous system toxicity can be seen in workers exposed to an elemental mercury level in the air of 20 µg/m 3 or more for several years. Kidney and immune effects have been reported. There is no conclusive evidence linking mercury exposure to cancer in humans. Children are especially vulnerable and may be exposed directly by eating contaminated fish. Methylmercury bioaccumulated in fish and consumed by pregnant women may lead to neurodevelopmental problems in the developing foetus. Transplacental exposure is the most dangerous, as the fetal brain is very sensitive. Neurological symptoms include intellectual disability, seizures, vision and hearing loss, delayed development, language disorders and memory loss. In infants and young children, a condition called acrodynia (or “pink disease”), characterized by red and painful extremities with local swelling and intense itching, and which can be accompanied by insomnia, irritability, and sensitivity to light, has been reported to result from chronic mercury exposure 3. Human exposure/risk evaluation 3.1 Food WHO (2003) Eating contaminated fish and shellfish is the main source of methylmercury exposure, especially in populations that rely heavily on consumption of predatory fish. Cooking does not eliminate mercury from fish. FAO and WHO guidance exists for national food safety authorities to assess the net health benefits or risks of fish consumption, taking into account the existing information on the benefits of eating fish 3.2 Air Colombia Studies conducted in Colombia by the Government of Antioquia in the municipalities of Segovia and Remedios, in the Northeast of the department, found a concentration of mercury of approximately 340 μg /m³ in the air (300 times higher than the guideline of the World Health Organization for public maximum exposure to vapour of mercury). WHO (2000) The atmosphere and dental amalgam are the sole sources of exposure to mercury vapour, whereas the diet is the dominant source of methylmercury compounds. Current levels of mercury in outdoor air, except for regional “hot spots”, are typically in the order of 0.005–0.010 µg/m 3 and thus are marginal compared to exposure from dental amalgam. The exposure to mercury from outdoor air at these air levels is not expected to have direct effects on human health. The LOAELs for mercury vapour are around 15–30 µg/m 3 . Applying an uncertainty factor of 20 (10 for uncertainty due to variable sensitivities in higher risk populations and, on the basis of dose–response information, a factor of 2 to extrapolate from a LOAEL to a likely NOAEL), a guideline for inorganic mercury vapour of 1 µg/m 3 as an annual average has been established. Since cationic inorganic mercury is retained only half as much as the vapour, the guideline also protects against mild renal effects caused by cationic inorganic mercury. Present knowledge suggests, however, that effects on the immune system at lower exposures cannot be excluded. 3.3 Water Colombia Studies conducted in Colombia by the Government of Antioquia in the municipalities of Segovia and Remedios, in the Northeast of the department, reported that a pproximately 26 to 6,118 ppm of Hg is discharged into rivers by miners in the region. Additionally, the main food of these communities is fish, which has been shown to be affected by the emission of mercury. Studies completed by Corantioquia , the University of Antioquia, and the University of Cartagena have revealed a concentration above 1.06 μg Hg/g in most of the species found in the rivers of the surrounding area . 3.4 Occupational exposure Colombia Occupational exposure is the most reported ca u se of mercury poisoning in Colombia , m ining and quarrying occupations have the highest number of cases due to the use of mercury in gold mining. The most frequent notifiers of poisoning cases during the review period were Antioquia, followed by Bogotá, Bolívar, Risaralda, Santander and Valle del Cauca. The highest percentage of intoxications reported were occupational, predominantly miners or stonemasons, with inhalation being the most frequent route of exposure . 3.5 Medical data contributing to regulatory decision Colombia According to the National Public Health Surveillance System - SIVIGILA, during 2010 and in the first half of 2011, 201 cases of mercury poisoning were reported in Colombia- 96% of the cases were of occupational or accidental origin as follows: 85% (n = 171) occupational, 11% (n = 22) accidental . 3.6 Public exposure Colombia Studies on populations with known exposures to mercury, including occupational and general population exposures, show a link between exposure and adverse health effects. The neuroepidemiological and toxicological study of the Suratá river pollutants carried out in the mining population of that region raised the possible relationship of chronic exposure to mercury with the presence of neurological diseases. It was further reported that the inhabitants of southern Bolívar presented signs of mercury intoxication such as hand tremors, neurological disorders and visual problems, among others. In this region, frequent cases of congenital malformations have also been reported, although without evidence of association with mercury exposure . 3.7 Summary-overall risk evaluation Colombia Data in the Colombian notification includes extensive neuro-epidemiological studies in exposed populations (occupational and general population) and studies in different environmental compartments (freshwater, soil, sediment, biota, etc.) and food (fish). Mercury measurements have been made in humans, mainly in workers and communities surrounding mining activities or adjacent to riverine areas. The evaluation establish ed that mercury is a toxic substance, that when entering the human body produces disorders, mainly at the central nervous system level. The presence of mercury in the air, water, soil and food (mainly fish) in concentrations above the allowed limit has caused a serious public health problem in Colombia. Regions such as the Northeast of Antioquia, the South of Bolívar, Chocó, Santander, Nariño, Caldas, Vaupés carry out artisanal gold mining using mercury for the final extraction of gold form ore . Its use occurs in an indiscriminate and poorly controlled way that has caused environmental contamination and has affected people's health. Exposure to mercury is also increased in industrial areas that use this substance . European Union While th e European Union’s risk assessment was conducted in the context of the restriction on mercury-containing measuring devices intended for industrial and professional uses, it includes information on the risks associated with mercury that is not limited to those measuring devices and that could support the other Directives and Regulations that comprise the final regulatory action notified by the European Union. A ccording to the ECHA Committee for Risk Assessment ( RAC ) O pinion and its background document, mercury and its compounds are highly toxic to humans, ecosystems and wildlife, with amongst others serious chronic irreversible adverse neurotoxic and neurodevelopmental effects. The RAC opinion includes a PBT assessment for mercury-methylmercury concluding and equivalent level of concern in terms of persistency, due to mercury cycling and methylation versus demethylation rates under anaerobic conditions, as well as the clear potential for bioaccumulation and toxicity identified for methylmercury . 4. Environmental fate and effects 4.1 Fate European Union Once released to the environment, mercury persists in the environment, where it circulates between air, water, sediments, soil and biota in various forms. Mercury can be transformed to methylmercury, the most toxic form, which biomagnifies especially in the aquatic food chain . 4.1.1 Soil European Union Mercury in soil is mostly bound to bulk organic matter and is susceptible to wash out in runoff only when attached to suspended soil or humus. Mercury has a long retention time in soil and as a result, the mercury accumulated in soil may continue to be released to surface waters and other media for long period of time, possibly hundreds of years. 4.1.2 Water UNEP (2002) From open ocean studies, it is apparent that elemental mercury, dimethylmercury and, to a lesser extent, methylmercury are common constituents of the dissolved mercury pool in deep ocean waters. In open ocean surface waters dimethylmercury is lacking, maybe as a result of decomposition in the presence of light and an additional potential loss via e vapour ation from the water surface. R esults suggest that low oxygen conditions are not necessary for the formation of dimethylmercury in the open oceans. This contrasts with temperate lake waters where methylmercury is more commonly occurring than dimethylmercury. Studies in freshwater and estuarine environments have shown that methylation of mercury is primarily taking place under low oxygen conditions and mainly by sulphate-reducing bacteria. Here methylmercury is the product of methylation of ionic mercury . 4.1.3 Air European Union Once released into the atmosphere, mercury can undergo long-range atmospheric transport, hence the atmosphere is the most important pathway for the worldwide dispersion and transport of mercury in the environment. Elemental mercury in the atmosphere can undergo transformation into inorganic mercury forms, providing a significant pathway for deposition of emitted elemental mercury. Mercury vapour has an atmospheric residence time that is between 0.4 and 3 years. Emitted mercury vapour is converted to soluble forms, these soluble forms have residence times of a few weeks. Soluble forms of mercury are deposited by rain into soil and water. 4.1.4 Bioconcentration European Union The bioconcentration factor (BCF) of methylmercury in fish can range from 8140 to 85 700. Methylmercury' biomagnification is very high with a typical increase of more than 1 log unit between trophic levels, and the bioaccumulation factor BAF can reach values 10 7 times higher than the concentration measured in water . 4.1.5 Persistence European Union Elemental mercury can be considered persistent , as it is not removed from the environment through degradation processes and will always be potentially available for cycling into methylmercury (through complex processes under appropriate conditions, even at equilibrium there is a near constant level of methylmercury in sediment). Any increase in the environmental pool of inorganic mercury will provide an additional source of methylmercury, and this source will persist for many years. 4.2 Effects on non-target organisms N/A 4.2.1 Terrestrial vertebrates European Union As in humans, mercury exposure of animals may result in severe neurological effects. These effects were clearly seen in the Minamata poisoning, where birds experienced severe difficulties in flying, and domestic animals, especially cats, showed signs of severe neurological intoxication. In birds, methylmercury has been associated with eggshell thinning in the 1950's and 1960's. Methylmercury was used as a fungicidal seed dressing, and severe poisoning of wildlife was observed in Scandinavia and North America. Populations of pheasants and other seed-eating birds, as well as birds of prey were drastically reduced and , in some areas , nearly disappeared. Adverse effects of mercury on reproduction can occur at egg concentrations as low as 0.05 to 2.0 mg/kg (wet weight). Eggs of certain Canadian species were reported to be in this range, and concentrations in the eggs of several other Canadian species were said to continue to increase and were approaching these levels. 4.2.2 Aquatic species European Union To adult fish, direct exposure to methylmercury from the surrounding water is generally not a serious concern. However , evidence suggests that mercury exposure to early life stages of some fish can affect growth, development and hormonal status at levels within a factor of 10 of levels encountered in “pristine” lakes. Effects from indirect exposure via dietary uptake and maternal transfer of methylmercury to eggs and developing embryos might be of concern . 4.2.3 Honeybees and other arthropods Not available 4.2.4 Earthworms Not available 4.2.5 Soil microorganisms European Union Mercury is toxic to micro-organisms and has long been used to inhibit the growth of bacteria in laboratory experiments. Evidence suggests that mercury is responsible for a reduction of micro-biological activity vital to the terrestrial food chain in soils over large parts of Europe – and potentially in many other places in the world with similar soil characteristics . 4.2.6 Terrestrial plants UNEP (2002) Terrestrial plants are fairly insensitive to the toxic effects of mercury compounds. Mercury is, however, accumulated in higher plants, especially in pere n nials. The primary effect observed in plants is associated with root tips. 5. Environmental exposure/risk evaluation 5.1 Terrestrial vertebrates UNEP (2002) On the global scale, the Arctic region has been in focus because of mercury’s particular tendency to long-range transport. It is important to acknowledge, however, that impacts of mercury are by no means restricted to the Arctic region. The same food web characteristics and similar dependence on a mercury contaminated food source are found in specific ecosystems and human communities in many countries around the world, particularly where a fish diet is predominant. Consequently, fish-eating birds and mammals are more highly exposed to mercury than any other known denizens of the aquatic ecosystem . 5.2 Aquatic species European Union The elimination of methylmercury from fish is very slow, which causes fish to accumulate methylmercury over time. Moreover, methylmercury biomagnifies throughout the many aquatic trophic levels. The highest levels in the aquatic food web are found in fish that are apical predators of older age (such as king mackerel, pike, shark, swordfish, walleye, barracuda, large tuna, scabbard, and marlin) and fish-consuming mammals such as seals and toothed whales . 5.3 Honeybees Not available 5.4 Earthworms Not available 5.5 Soil microorganisms Not available 5.6 Summary – overall risk evaluation European Union Mercury occurs both naturally and as an introduced contaminant in the environment. Anthropogenic emissions have widespread impacts on human and environmental health. Mercury is a globa l pollutan t that cannot be broken down in the environment to any harmless form. Once emitted, mercury enters the complex biogeochemical cycle. After intensive use of mercury over many years mercury can be found in almost all environmental compartments, like the atmosphere, soil and water systems and in biota all over the world. The formation of methylmercury and subsequent biomagnification in food chains considerably increases risks posed by mercury causing, among others, chronic intoxications of people, although it is difficult to determine the proportion of mercury contaminating the environment, which is turned into methylmercury. Therefore , it is necessary to reduce the risk of exposure to mercury for humans and the environment. The key, long term benefit of reducing mercury emissions will be decreased levels of mercury in the environment. This, in turn, will lead to lower levels of human exposure to mercury, including methylmercury in fish, with resultant health benefits. It will also reduce the impacts of mercury on soils and biodiversity. Annex 2 : Details on final regulatory actions reported Colombia 1 . Effective date(s) of entry into force of actions 15 July 2013 Reference to the regulatory document Ley 1658 de 2013 (Anexo I) DIARIO OFICIAL A Ñ O CXCLIX. N. 48.852. 15, JULIO, PAG.6 http://www.suin-juriscol.gov.co/viewDocument.asp?ruta=Leyes/1685943 2 . Succinct details of the final regulatory action(s) Based on Law 1658 of 15 July 2013, the government of Colombia prohibited the marketing and use of mercury. The regulation eradicates the use of mercury in the national territory in: 1) all industrial and production processes within a period not exceeding 10 years (till 15 July 2023), and 2) for mining within a maximum period of 5 years (till 15 July 2018). Currently the deadline for industrial uses other than mining has not been met; this is the reason why the use of mercury in the production of dental amalgam will continue until 15 July 2023 . 3 . Reasons for action The government of Colombia prohibited the marketing and use of mercury under Law 1658 of 15 July 2013. It was determined that in order to protect and safeguard the human health and preserve renewable natural resources and the environment, the use, import, production, marketing, handling, transportation, storage, final disposal and release into the environment of mercury in industrial activities, whatever they may be, must be regulated throughout the national territory. Specifically, Article 3 of the law establishes the measures to reduce and eliminate the use of mercury in the country as follows: "Article 3. Reduction and elimination of the use of mercury. The Ministries of Environment and Sustainable Development; Mines and Energy; Health and Social Protection and Work, will establish the necessary regulatory measures that will allow to reduce and eliminate, in a safe and sustainable way, the use of mercury in the different industrial activities of the country. Eradicate the use of mercury throughout the national territory, in all industrial and productive processes within a period not exceeding ten (10) years and for mining within a maximum period of five (5) years. 4 . Basis for inclusion into Annex III The final regulatory action was taken to protect human health and the environment. The regulatory action was based on a risk evaluation taking into account the prevailing conditions in Colombia. 4.1 Risk evaluation According to the evaluation related to human health and the environment, the following information was identified (UNEP/FAO/RC/CRC.19/11 and UNEP/FAO/RC/CRC.19/INF/24): The data includes extensive neuro-epidemiological studies in exposed populations (occupational and general population) and studies in different environmental compartments (freshwater, soil, sediment, biota, etc.), food (fish), with a view of establishing the levels of mercury and the perception of risk, and generating scientific, regulatory and technical evidence on the mercury problem both at the national and international level of the health sector and other related sector. Mercury measurements have been made in humans, mainly in workers and communities surrounding mining activities or adjacent to riverine areas. The evaluation conducted establish that mercury is a toxic substance, that when entering the human body produces disorders, mainly at the central nervous system level. The presence of mercury in the air, water, soil and food (mainly fish) in concentrations above the allowed limit has caused a serious public health problem in Colombia. Regions such as the Northeast of Antioquia, the South of Bolívar, Chocó, Santander, Nariño, Caldas, Vaupés, among others, carry out artisanal gold mining and for the final extraction of this precious metal, mercury is used. Its use occurs in an indiscriminate and poorly controlled way, a situation that has caused environmental contamination and has affected people's health. Exposure to mercury is also increased in industrial areas that use this substance. Studies conducted by the Government of Antioquia in the municipalities of Segovia and Remedios, in the Northeast of the department, found a concentration of mercury of approximately 340 μg /m³ in the air (300 times higher than the guideline of the World Health Organization for public maximum exposure to vapour of mercury). Approximately 26 to 6,118 ppm of Hg is discharged into rivers by miners in the region. Additionally, the main food of these communities is fish, which has been shown to be affected by the emission of mercury. Studies completed by Corantioquia , the University of Antioquia, and the University of Cartagena have revealed a concentration above 1.06 μg Hg/g in most of the species found in the rivers of the surrounding area. Mercury contamination in Colombia is mostly caused by its use in the extraction of gold from ore . In this process, elemental mercury is added to gold containing ores and minerals to form a gold amalgam. M ercury used this way may spill into water bodies and the environment. Subsequently, the gold amalgam is recovered and burned in the open air to extract the gold , which release toxic mercury vapour s into the atmosphere. All these activities are performed very close to the miners' households, in such a way that families breathe a large part of the volatilized mercury vapour. Even remote populations can be affected by the mobilization of this substance (Protocol for Surveillance and Control of Acute Mercury Poisoning . INF/30, Annex III) . Studies on populations with known exposures to mercury, including occupational and general population exposures, show a link between exposure and adverse health effects (Fawer et al 1983, Piikivi 1989, Marh et al 1987). The neuroepidemiological and toxicological study of the Suratá river pollutants carried out in the mining population of that region (Santander, 1992) raised the possible relationship of chronic exposure to mercury with the presence of neurological diseases. Tirado et al (2000) suggest that this form of exposure can cause neuropsychological and behavioural deficits in the population. In 1995, Olivero et al reported that the inhabitants of southern Bolívar presented signs of mercury intoxication such as hand tremors, neurological disorders and visual problems, among others. In this region, frequent cases of congenital malformations have also been reported, although without evidence of association with mercury exposure. According to National Public Health Surveillance System - SIVIGILA, during 2010 and in the first half of 2011, 201 cases of mercury poisoning were reported in Colombia- 96% of the cases were of occupational or accidental causes as follows: 85% (n = 171) occupational, 11% (n = 22) accidental. Occupational exposure is the most reported cause of mercury poisoning in Colombia. Mining and quarrying occupations have the highest number of cases due to the use of mercury in gold mining. The most frequent notifiers of poisoning cases during the review period were Antioquia, followed by Bogotá, Bolívar, Risaralda, Santander and Valle del Cauca. The highest percentage of intoxications reported were occupational, predominately miners or stonemasons, with inhalation being the most frequent route of exposure (Scientific, Regulatory and Technical Evidence on the Mercury Problem at the Level National and International Health Sector and Other Related Sectors. Revision Systematics of Literature, INF/30, Annex IV) . S ome population groups may need special consideration in relation to exposure to mercury, since they have a greater probability of exposure to dangerous levels, or because carriers of disease, the intoxication effects can be exacerbated: Workers exposed to mercury; General population next to sources of mercury contamination (mines, industries); Populations in areas contaminated by mercury, especially indigenous and riverine, whose main source of proteins is fish; People using mercury-containing medications for a long time; People with central nervous system diseases, patients with chronic kidney and bronco pulmonary failure; Pregnant women and toddlers . 4.2 Criteria used Risks to human health and the environment . Relevance to other States and Region The notification states that mercury can be used in other countries for the manufacture of products with added mercury and in gold extraction, mainly in developing countries . T herefore , the considerations leading to the final regulatory action being taken are expected to be applicable to other geographical area where mercury is used in similar conditions. 5 . Alternatives None reported 6 . Waste management None reported 7 . Other None reported European Union 1 . Effective date(s) of entry into force of actions Directive 2006/66/EC entered into force on 26 September 2006 ; Directive 2007/51/EC started to apply on 3 April 2009 ; Commission Regulation (EC) No 552 /200 9 entered into force 27 June 2009 ; Directive 2011/65/EU entered into force 21 July 2011 ; Commission Regulation (EU) No 847/2012 started to apply on 10 April 2014 ; Regulation (EU) 2017/852 entered into force on 13 June 2017 . Reference to the regulatory document Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC . http://data.europa.eu/eli/dir/2006/66/2018-07-04 Directive 2007/51/EC of the European Parliament and of the Council of 25 September 2007 amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury . http://data.europa.eu/eli/dir/2007/51/oj Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII . http://data.europa.eu/eli/reg/2009/552/oj Commission Regulation (EU) No 847/2012 of 19 September 2012 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards mercury . http://data.europa.eu/eli/reg/2012/847/oj Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. http://data.europa.eu/eli/dir/2011/65/2020-09-01 Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008. http://data.europa.eu/eli/reg/2017/852/oj 2 . Succinct details of the final regulatory action(s) The use of mercury as an industrial chemical is severely restricted in the European Union pursuant to Regulation (EU) 2017/852 on mercury, Regulation (EC) 1907/2006 (REACH), Directive 2011/65/EU (RoHS) and Directive 2006/66/EC (batteries and accumulators). More specifically: In 2006, Directive 2006/66/EC introduced a prohibition on the placing on the market of batteries and accumulators containing mercury; In 2007, Directive 2007/51/EC introduced a restriction under Directive 76/769/EEC on the placing on the market of mercury in fever thermometers and in other measuring devices intended for sale to the general public; Regulation (EC) No 1907/2006 (REACH) repealed Directive 76/769/EEC. Commission Regulation (EC) No 552/2009 amended Annex XVII to REACH by incorporating in entry 18.a the restrictions on certain measuring devices containing mercury that was adopted under Directive 2007/51/EC; In 2011, Directive 2011/65/EU (RoHS) established a restriction on the placing on the market of electric and electronic equipment to a maximum concentration value of 0.1% of mercury, allowing exemptions for certain applications for a limited time period; Commission Regulation (EU) No 847/2012 amended Annex XVII to REACH by incorporating in entry 18.a. a restriction on the placing on the market of mercury-containing and mercury- using measuring devices intended for industrial and professional uses. The restriction started to apply from 10 April 2014; Regulation (EU) 2017/852 on mercury was adopted in May 2017. This regulation complements the European Union acquis and lays down the provisions that are needed to ensure the complete alignment of the European Union acquis with the Minamata Convention on Mercury establishing measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste. 3 . Reasons for action T he final regulatory action has been taken in order to protect human health and the environment and further explain s that mercury is a chemical of global concern owing to its long-range atmospheric transport, its persistence in the environment once anthropogenically introduced, its ability to bioaccumulate in ecosystems and its significant negative effects on the environment and on human health, which include significant adverse neurological and other health effects, with particular concerns expressed about its harmful effects on infants and unborn children. Mercury can be transformed to methylmercury, the most toxic form, which biomagnifies especially in the aquatic food chain, making populations and wildlife with a high intake of fish and seafood particularly vulnerable. 4 . Basis for inclusion into Annex III The final regulatory action was taken to protect human health and the environment. The regulatory action was based on a risk evaluation taking into account the prevailing conditions of use of mercury in the European Union. 4.1 Risk evaluation According to the evaluation related to human health and the environment, the following information was identified (UNEP/FAO/RC/CRC.1 9 /1 1 and UNEP/FAO/RC/CRC.19/INF/2 2) : While this risk assessment was conducted in the context of the restriction on mercury-containing measuring devices intended for industrial and professional uses, it includes information on the risks associated with mercury that is not limited to those measuring devices and that could support the other Directives and Regulations that comprise the final regulatory action notified by the European Union ; According to the ECHA Committee for Risk Assessment ( RAC ) O pinion and its background document, mercury and its compounds are highly toxic to humans, ecosystems and wildlife, with amongst others serious chronic irreversible adverse neurotoxic and neurodevelopmental effects. The RAC opinion does not explicitly conduct a PBT assessment for mercury-methylmercury , but it does note that it should be considered with an equivalent level of concern in terms of persistency, due to mercury cycling and methylation versus demethylation rates under anaerobic conditions, as well as the clear potential for bioaccumulation and toxicity identified for methylmercury ; The hazard and fate of mercury and its compounds are described in numerous peer-reviewed reports, which were referenced in the Document ation provided: ‘Global Mercury Assessment’, published by UNEP in 2002 (and UNEP 2008a and b); ‘Methylmercury’ (WHO, 1990); ‘Risks to Health and the Environment Related to the Use of Mercury Products’ prepared for the Commission by RPA in 2002 ; It is estimated that 3.5–7.6 tonnes of mercury are placed on the market in mercury containing measuring devices in 2010. These amounts are used to estimate the maximum potential for mercury emissions to the environment that might ultimately occur. This assumption is considered appropriate because of an estimated low separate collection rate of mercury waste and resulting inadequate waste treatment of a substantial part of the devices. This inappropriate waste collection leads in the long term to a relatively high share of mercury used in these devices being released to the environment. For measuring equipment using mercury (porosimeters, mercury probes used for capacitance-voltage determinations and mercury electrodes used in voltammeters) the total use is 5–15 tonnes per year (mostly porosimeters 5–14 tonnes per year). It should be noted that these figures are the amount of mercury the laboratories purchase and cannot be used to estimate maximum potential for emission as is the case for the measuring equipment containing mercury. To estimate emissions several additional factors need to be considered. These include number of measurements carried out, practices to purify and regenerated used mercury and the risk management measures and operational conditions applied to control the emissions and exposures ; The total mercury consumption in Europe was in 2007 estimated to be 320–530 tonnes. 160–190 tonnes of the total amount were used in the chlor-alkali production and 90–110 were used in dental amalgams. The amount used in mercury measuring devices thus equals about 4% of the total, while the restricted devices will be lower due to the large use in porosimeters ; Once released to the environment, mercury persists in the environment, where it circulates between air, water, sediments, soil and biota in various forms. Mercury can be transformed to methylmercury, the most toxic form, which biomagnifies especially in the aquatic food chain, making populations and wildlife with a high intake of fish and seafood particularly vulnerable ; Several existing pieces of legislation in the European Union abate the risks arising from mercury in different stages of the life cycle of measuring devices. However, none of the measures currently in place is sufficient to remove the concern fully, although there is a difference between their observed effectiveness with regard to measuring devices containing mercury and measuring devices using mercury ; The emissions from mercury measuring devices, although relatively small, contribute to the overall emissions of mercury to the environment and thereby also to the exposure of species and of humans via the environment. Therefore, measuring devices containing or using mercury are of concern . 4.2 Criteria used Risks to human health and the environment Relevance to other States and Region T he notification states that similar human health and environmental problems are likely to be encountered in other regions where the substance is used, particularly in developing countries and especially for women and children, and, through them, future generations. 5 . Alternatives None reported . 6 . Waste management Regulation (EU) 2017/852 on mercury was adopted in May 2017. This regulation complements the European Union acquis and lays down the provisions that are needed to ensure the complete alignment of the European Union acquis with the Minamata Convention on Mercury establishing measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste . 7 . Other None reported . Annex 3 : Addresses of designated national authorities Colombia Rotterdam Convention Designated national authority for industrial chemicals (DNA C ) Name: Ms. Andrea Patricia Soler Galindo Job title: Coordinadora Grupo Desarrollo y Salud Department: Subdirección de Salud Ambiental Institution: Ministerio de Salud y Protección Social Postal address: Carrera 13 # 32 - 76 Piso 14, Edificio Urano Bogotá D.C. Colombia Phone: +57 1 330 5000 ext. 1241 Email: [email protected] ; [email protected] o European Union Rotterdam Convention Designated national authority for industrial chemicals and pesticides (DNA CP), Rotterdam Convention Official contact point (OCP) . Name: Mr. Juergen Helbig Job title: International Chemicals Policy Coordinator Department: DG Environment, Unit ENV.B2 - Safe and Sustainable Chemicals Institution: European Commission Postal address: 1049 Brussels Belgium Phone: +32 2 298 8521 Fax: +32 2 298 8874 Email: [email protected] C Industrial chemicals CP Pesticides and industrial chemicals P Pesticides Annex 4 : References 1. Regulatory actions Colombia Ley 1658 de 2013 (Anexo I) DIARIO OFICIAL A Ñ O CXCLIX. N. 48.852. 15, JULIO, PAG.6 http://www.suin-juriscol.gov.co/viewDocument.asp?ruta=Leyes/1685943 European Union Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC . http://data.europa.eu/eli/dir/2006/66/2018-07-04 Directive 2007/51/EC of the European Parliament and of the Council of 25 September 2007 amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury http://data.europa.eu/eli/dir/2007/51/oj Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII http://data.europa.eu/eli/reg/2009/552/oj Commission Regulation (EU) No 847/2012 of 19 September 2012 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards mercury http://data.europa.eu/eli/reg/2012/847/oj Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. http://data.europa.eu/eli/dir/2011/65/2020-09-01 Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008. http://data.europa.eu/eli/reg/2017/852/oj 2. Supporting Documentation Mercury: n oti fications of final regu latory action . UNEP/FAO/RC/CRC.19/11 Supporting documentation provided by Columbia. UNEP/FAO/RC/CRC.1 9 /INF/ 22 Supporting documentation provided by the European Union s. UNEP/FAO/RC/CRC.1 9/INF/24 3. Other Documents E CHA registration dossier 5169 (Mercury) , accessed at: https://echa.europa.eu/registration-dossier/-/registered-dossier/5169 IARC (1993), IARC Monographs on the Evaluation of Carcinogenic Risks to humans, Beryllium, Cadmium, Mercury and Exposures in Glass Manufacturing Industry, Volume 58. https://publications.iarc.fr/_publications/media/download/1954/ed5ada49ff1536d1474abdb982ee69583dbf1bc2.pdf IRIS (1995a). Mercury elemental; CASRN 7439-97-6. https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0370_summary.pdf IRIS(1995b). Mercuric chlori d e (HgCl2); CVASRN 787-94-7. https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0692_summary.pdf IRIS (2001). Methylmercury ( MeHg ); CASRN 22967-92-6. https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0073_summary.pdf SCOEL /SUM / 84 (2007). Recommendation from the Scientific Committee on Occupational Exposure Limits for elemental mercury and inorganic divalent mercury compounds . May 2 0 07. http://ec.europa.eu/social/BlobServlet?docId=3852&amp;langId=en UNEP (2002): Global Mercury Assessment. UN Environment Programme, Chemicals Branch, Geneva, Switzerland. https://www.unep.org/globalmercurypartnership/resources/report/global-mercury-assessment-2002 UNEP (2008): The Global Atmosph e ric Mercury Assessment : Sources, Emissions and Transport. UN Environment Programme, Chemicals Branch, Geneva, Switzerland. https://www.unep.org/globalmercurypartnership/resources/report/global-atmospheric-mercury-assessment-sources-emissions-and-transport-2008 . UNEP (2013): Global Mercury Assessment 2013: Sources, Emissions, Releases and Environmental Transport. UNEP Chemicals Branch, Geneva, Switzerland. Global Mercury Assessment 2013: Sources, emissions, releases, and environmental transport (unep.org) UNEP ( 2017 ). Global mercury supply, trade and demand. United Nations Environment Programme, Chemicals and Health Branch. Geneva, Switzerland. https://www.unep.org/resources/report/global-mercury-supply-trade-and-demand UNEP (2019): Global Mercury Assessment 2018. UN Environment Programme, Chemicals and Health Branch, Geneva, Switzerland. https://www.unep.org/resources/publication/global-mercury-assessment-2018?_ga=2.172454499.1370957274.1702051132-948088036.1661281591 WHO ( 2000 ). Air quality guidelines for Europe, 2nd ed.. World Health Organization. Regional Office for Europe. https://iris.who.int/handle/10665/107335 WHO (2003) . Elemental mercury and inorganic mercury compounds: human health aspects, Concise International Chemical Assessment Document 50 . World Health organization . https://www.inchem.org/documents/cicads/cicads/cicad50.htm WHO ( 2021 ) . E xposure to mercury: a major public health concern , second edition. Preventing disease through healthy environments. World Health Organization. https://www.who.int/publications/i/item/9789240023567 ___________________ Excerpt from the Handbook of the Chemical Review Committee Working paper on preparing internal proposals and decision guidance documents for banned or severely restricted chemicals 1.2 Working paper on preparing internal proposals and decision guidance documents for banned or severely restricted chemicals Reference: UNEP/FAO/RC/CRC. 14/10 This document provides guidance to intersessional drafting groups of the Chemical Review Committee (CRC) in the preparation of decision guidance documents for banned or severely restricted chemicals. It is designed to clarify the purpose of each section of the decision guidance document and to characterize the information to be included. The working paper, originally developed by the interim CRC, was adopted at the first meeting of the CRC. Subsequent meetings of the CRC have reviewed and amended this working paper based on the experience gained in drafting decision guidance documents. This most recent version was approved by the fourteenth meeting of the CRC with the understanding that it would continue to evolve in the light of future experience. Purpose This working paper is to serve as guidance to drafting groups established by the Chemical Review Committee for the preparation of decision guidance documents for banned or severely restricted chemicals in accordance with Article 5 of the Rotterdam Convention. This working paper is intended: To clarify the purpose of each section of the decision guidance document; To characterize the information to be included; To define acceptable sources of information for each section. This working paper is expected to evolve as further experience is gained in the preparation of decision guidance documents. It is to be used by drafting groups preparing decision guidance documents for both pesticides and industrial chemicals. In this version of the working paper those sections which are potentially different for industrial chemicals and pesticides have been highlighted. If required, future versions of the working paper may be split into two separate working documents, one for pesticides and one for industrial chemicals. A separate working paper has been developed for the preparation of decision guidance documents for severely hazardous pesticide formulations in accordance with Article 6 of the Rotterdam Convention. In order to further facilitate the work of the drafting groups an electronic template of a draft decision guidance document has been prepared as a companion document to this working paper. General guidance In preparing each decision guidance document a standard cover/title page will be added as will a version of the standard introductory text developed at the fourth session of the interim Chemical Review Committee. This text provides a brief summary of the process through which the individual decision guidance document was developed and includes three separate sections an introduction, purpose and disclaimer. In cases where a decision guidance document includes more than one chemical ( e.g . asbestos), a table of contents will facilitate the use of the document. Similarly the insertion of footers identifying the chemical should be included on each page. A standard list of “core” abbreviations has been prepared based on experience in drafting decision guidance documents to date. It is intended that this core list should serve as the basis for decision guidance documents for both industrial chemicals and pesticides and that it should be augmented by abbreviations used in the individual decision guidance documents relevant to the chemical(s) in question. This core list of abbreviations is appended to this working paper (appendix 1). As a general rule it is preferable that acronyms used only once in the text be spelled out rather than included in the list of abbreviations. In preparing a decision guidance document, it may be that not all sections are relevant to the chemical under consideration. It is preferable, in this case, to include a phrase along the lines of ‘not applicable’, rather than deleting the section or leaving it blank. This clearly indicates that the drafting group had considered that section. 1. Identification and uses Purpose: To provide an unequivocal identification of the chemical subject to the PIC procedure and its use as either a pesticide or an industrial chemical, or both. This basic information should be obtainable from the submitted notifications and the supporting material available to the Committee prior to its decision to develop a decision guidance document. CAS numbers for all forms of the chemical covered in the relevant notifications of final regulatory action should be included here. The scope of the chemical identified in this section (chemical description and associated CAS numbers) must be consistent with the recommendation by the Chemical Review Committee (CRC) for inclusion of the chemical in Annex III of the Convention. Should additional CAS numbers be found during the development of the decision guidance document, they should be brought to the attention of the CRC. If they do not broaden the scope of the original notification, they could be included here. Chemical structural formula should be included if practicable. Structural formula may be found in standard references documents on pesticides e.g . The Pesticide Manual. Notes: Updated or additional information on trade names, formulation types and basic manufacturers for products moving in international trade may be identified through the responses to the call for information on on-going manufacture, use and trade of the chemical. The list of trade names, formulation types and manufacturers should, where possible, distinguish old products from those that are known to be moving in international trade. It is clear that a list of both manufacturers and trade names will be constantly changing, for this reason a generic disclaimer along the following lines should be considered: Under trade names: This is an indicative list of trade names. It is not intended to be exhaustive. Under basic manufacturers: This is an indicative list of current and former manufacturers of XXX. It is not intended to be exhaustive . In accordance with article 7, when a chemical may be used as both a pesticide and an industrial chemical (a dual-use chemical), the decision guidance document should provide information on uses in both categories. A statement on “reported use in X category” or “no reported uses in X category” should be given (where X is either an industrial chemical for a pesticide decision guidance document or a pesticide for an industrial chemical). 2. Reasons for inclusion in the PIC procedure Purpose: To provide a generic statement that clearly identifies the use category (pesticide or industrial chemical) and whether the chemical is subject to a ban or severe restriction in the notifying countries. References to any previous listing(s) under the PIC procedure should also be included, where relevant. For dual-use chemicals, it will also be important to note when the PIC obligations do not apply to the use category that was not regulated. Example: [Chemical X] is included in the PIC procedure as a pesticide. It is has been listed on the basis of the final regulatory actions to severely restrict its use, notified by [Country 1] , and to ban its use, notified by [Country 2] . No final regulatory actions relating to industrial chemical uses have been notified. List notifying countries alphabetically. 2.1. Final regulatory action Purpose: To provide a brief statement/summary of the final regulatory action(s) as reported by the notifying countries and the reasons for the actions taken ( e.g ., occupational health concerns, environmental concerns). The text should reflect the reasoning used by the regulatory authority to underpin the national regulatory action(s) – for example, as presented in national law, regulation, gazette, legal journal, code. Specific reference to the relevant directive or regulation for the reported regulatory action(s) should be included in annex 2. The reason(s) stated should set the stage for the subsequent description of the underlying risk evaluation. National authorities should ensure that any technical legal references, if they are used, are accurate. 2.2. Risk evaluation Purpose: To provide a brief summary (no more than 1-2 pages) highlighting the key reported finding(s) of the national risk evaluation(s) that led to the regulatory action(s). The text should reflect the reason(s) identified in the final regulatory action(s) by the notifying countries and include information on the uses that were permitted prior to the regulatory action. In the interests of brevity, the text may include references to Convention Annexes I and II for additional details. Note: Depending on the chemical and the finding(s) of the national risk evaluations, this section may provide information on an individual country basis, or, where there are multiple country notifications based on common human health or environmental concerns, the information may be summarized and combined. It would also be useful to highlight the differences in regulatory actions, if they are not already obvious. 3. Protective measures that have been applied concerning the chemical Purpose: To highlight measures taken to reduce exposure, in the first instance through regulatory controls or measures and secondly through other measures (administrative, non-legal/voluntary codes of practice, field practice, etc.) recalling that: A ban in the regulated category of use eliminates all exposure (occupational or environmental); and A severe restriction in the regulated category of use allows continued use in a manner that reduces risk to an “acceptable” level. 3.1. Regulatory measures to reduce exposure Purpose: To provide information on the regulatory measures taken to ban or severely restrict the chemical and associated products. for bans , the risk has been eliminated and therefore a simple explanation of the risk management strategy to deal with existing stocks may be enough; and for severe restrictions , briefly describe the regulatory measures taken/set in place to reduce the risk to acceptable levels - e.g . by restricting access to trained/certified applicators or requiring purchasers to be licensed. 3.2. Other measures to reduce exposure This section is primarily intended for additional information from the notifying country(ies) on chemicals that have been severely restricted e.g. chemicals where for which virtually all use has been prohibited. For most banned chemicals this section would not be completed. The exception is where there was relevant chemical specific information from either the notifying country or international sources on possible risk mitigation measures. Purpose: To provide information about non-regulatory measures (including technical and field-level arrangements) for severely restricted chemicals taken/set in place to reduce exposure and ensure that risk remains at an acceptable level for the uses that are permitted to continue. Information could include, for example changing the type of formulation or application equipment used, specifying the personal protective equipment or clothing required. Where available, information from the notifying country or international sources of information on chemical specific risk mitigation measures may also be referenced. Examples may include publications from the International Labo u r Organization or International Standards Organization. It is not intended that generic information on handling hazardous chemicals would be included in this section. Note: In order to maintain the timeliness and accuracy of this information, it is preferable to include references to additional sources of information (electronic links, etc) for a specific chemical on the Rotterdam Convention website. New sources of such information could also be included in a series of up-dates that could be distributed to designated national authorities along with the PIC circular. 3.3. Alternatives Purpose: To provide countries with brief information about alternatives that have been identified by the notifying country or countries and others where available. It is not be feasible for the decision guidance document to contain a comprehensive list of specific pest crop complexes and recommended pesticides or non-chemical alternatives, particularly for pesticides that have a broad spectrum of activity. As the available alternatives are constantly evolving, identifying sources of information is likely to be more useful and more reliable than a list of specific recommendations. Notifying countries may provide information about chemical and non-chemical alternatives that are being used within their jurisdictions. Detailed information can be included in annex 2. Information from sources other than the notifying country might be referenced here with details on where the information might be found provided to DNAs through the PIC Circular and the Rotterdam Convention website (see following note). Note: While recognizing that a range of chemical and non-chemical alternatives may be available, this section should include a generic statement on the need for caution in considering them or using them and should remind parties of the need to ensure that they are appropriate to national circumstances. In order to maintain the timeliness and accuracy of this information, it is preferable to include references to additional sources of information (electronic links, etc.) for a specific chemical on the Rotterdam Convention website. Such new sources of such information could be included in a series of up-dates that could be distributed to designated national authorities along with the PIC circular and also used in workshops. The following is an example of standard text for this section related to pesticides. There are a number of alternative methods involving chemical and non-chemical strategies, including alternative technologies available, depending on the individual crop-pest complex under consideration. Countries should consider promoting, as appropriate, integrated pest management (IPM) and organic strategies as a means of reducing or eliminating the use of hazardous pesticides. SAICM’s Fourth International Conference on Chemicals Management recommended that in replacing highly hazardous pesticides the focus should be on agroecologically-based practices. Advice may be available through National IPM focal points, the FAO, IFOAM (International Federation of Organic Movements) and agricultural research or development agencies. Where it has been made available by governments, additional information on alternatives to XXXX may be found on the Rotterdam Convention website www.pic.int . Information on such agroecologically-based practices can be found at the following websites: FAO Agroecology hub: http://www.fao.org/agroecology/en/ IPAM (International Peoples Agroecology Multiversity): http://ipamglobal.org/ OISAT (Online Information Service for Non-Chemical Pest Management in the Tropics): http://www.oisat.org/ Replacing Chemicals with Biology: Phasing out Highly Hazardous Pesticides with Agroecology: http://panap.net/2015/11/replacing-chemicals-biology-phasing-highly-hazardous-pesticides-agroecology/ It is essential that before a country considers substituting alternatives, it ensure that the use is relevant to its national needs and the anticipated local conditions of use. The hazards of the substitute materials and the controls needed for safe use should also be evaluated. For industrial chemicals , the final paragraph above should be used, to indicate the need to consider the hazards associated with possible alternatives. National alternatives should be included, and if international organizations have discussed alternatives in reviews etc. this information could also be included. 3.4. Social and economic effects This section would only be completed where Notifying Countries have undertaken specific studies of the social and economic effects related to their final regulatory action(s) and wish to report on their findings. Note: Most countries do not undertake rigorous social and economic studies that are relevant beyond their own jurisdictions, but they may provide information on alternatives when a country took an action to restrict a chemical. This information is optional. When reported, there will need to be a caveat that countries consider the results of this information in the context of their own national conditions. 4. Hazards and risks to human health and/or the environment 4.1 Hazard Classification Purpose: To provide a brief summary of internationally recognized classifications applied to the chemical(s) for which the decision guidance document has been prepared. This section should focus on internationally recognized standards such as IARC, WHO/IPCS classification systems. The standard reference for LD 50 values is the most recent edition of the WHO/IPCS publication, recommended classification of pesticides by hazard and guidelines to classification . The WHO classification schemes for pesticides as well as its formulations are based on oral or dermal toxicity. According to the WHO guideline, the route which indicate greater hazard would be chosen for its classification. As far as possible, information on the WHO hazard classification of liquid and solid formulations should be included. The US EPA and European Union classification systems have been included as they are widely used by many countries as a reference. All references should include the date when they were established. Note: It is not intended that national standards be included here, notifying countries should include their national classification schemes in Annex 2. The following is an example of how this information might be presented: 4. Hazards and Risks to human health and the environment 4.1 Hazard Classification WHO / IPCS Technical product a.i.: Insert classification e.g. Class Ia (extremely hazardous) Classification based on oral or dermal toxicity in rats LD 50: (WHO reference) Formulations a.i. (%) Hazard class Liquid Solid IARC Group 3: the agent is not classified as to its carcinogenicity to humans. (IARC reference) European Union Classification of the active substance is (Commission Directive reference): T (toxic) Xi (Irritant) N (dangerous for the environment) R 24/25 (Toxic in contact with skin/ if swallowed) R 36 (Irritating to eyes) R 50/53 (Very toxic to aquatic organisms / may cause long-term adverse effects in the aquatic environment) US EPA Toxicity Class I (formulation) (EPA reference) 4.2. Exposure limits Purpose: To provide a brief summary of internationally recognized exposure limits as applied to the chemical(s) subject to the decision guidance document. This section should focus on those exposure limits that are internationally recognized, e.g ., Codex levels in food, WHO drinking water guidelines, etc. All references should include the date when they were established and the date of any subsequent review by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR), etc. It is not intended to capture occupational exposure limits such as Threshold Limit Values (TLVs) for pesticides largely because of the widely differing ways in which they may be calculated Note: It is not intended that national standards be included here as their applicability to other countries is limited without a good understanding of how the limits were derived. Notifying countries could include them in Annex 2 if they feel it is appropriate and necessary. If no international exposure limits are available, the words ‘not applicable for this chemical’ could be inserted. 4.3 Packaging and labelling Purpose: To provide a quick reference to existing standards for packaging and labelling of the chemical. This section should focus on internationally recognized classifications established by the United Nations Committee of Experts on the Transport of Dangerous Goods, and on the Globally Harmonized System of Classification and Labelling of Chemicals (if used), the International Maritime Dangerous Goods Code, etc., along with relevant explanatory text if applicable ( i.e. for specific requirements). Note: In the case of pesticides, this section should include a generic statement on the availability of further specific guidance on appropriate symbols and label statements for individual pesticides and formulations in the FAO Guidelines on Good Labelling Practice for Pesticides . 4.3 Packaging and labelling The United Nations Committee of Experts on the Transportation of Dangerous Goods classifies the chemical in: Hazard Class and Packing Group: International Maritime Dangerous Goods (IMDG) Code Transport Emergency Card 4.4. First aid Purpose: To provide a quick reference to internationally recognized information on the treatment of chemical poisoning (pesticides and industrial chemicals) available at the time of publication of the decision guidance document. Reference should be generic and include the most recent WHO/IPCS recommendation. It should note any aspects specific to the chemical cited in the decision guidance document. A reference to the WHO website for other relevant information might also be included www.inchem.org Notes: For chemicals that are not acutely toxic, this section may not be relevant and could be completed with the statement “ not applicable to this chemical ”. Recognizing that a range of first-aid treatments may be available, this section should include a generic statement on the need for caution and should remind parties of the need to ensure that this information is in compliance with any national standards that may exist. 4.5. Waste management Purpose: To ensure that countries are aware of the need for appropriate management of wastes and to provide references to relevant guidance and other sources of information. This section should include references to appropriate internationally recognized guidelines such as those developed by FAO for pesticides. Particular attention should be drawn to the relevant terms of international agreements – the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal. Notifying countries may wish to note specific actions taken to avoid the creation of stockpiles, including arrangements to permit use of existing stocks during a phase-out period. Annex 1 . Further information on the chemical Annex 1 contains information submitted by the notifying countries based on the national assessments which were used to support the reported final regulatory action. The results of international reviews such as those of WHO/IPCS/JMPR/IARC should also be included in this section where available and considered relevant. Subsequent evaluations or reviews of the chemical from Parties, other than those that submitted the notifications of final regulatory actions may be submitted to the secretariat for posting on the Rotterdam Convention website. Purpose: To provide an overall summary of information on the chemical for which the reported regulatory action(s) have been taken, including physico-chemical properties of the substance and/or product(s) and the results of toxicological and ecotoxicity studies. The decision guidance document is not intended to be a scientific treatise on a chemical. The emphasis should be on the concerns that formed the basis of the reported final regulatory action(s). For example, if the sole basis of the reported regulatory action(s) is unacceptable occupational exposure, this annex section should focus on human health effects rather than environmental aspects. The principal headings in this annex generally reflect those used by OECD countries and the European Union in their monographs. This approach will assist all countries, especially developing countries, which may have used an OECD/European Union monograph as the basis for the risk evaluation supporting their final regulatory action(s). The generic headings and general guidance on content should facilitate consistency in the format and content of decision guidance documents. The introduction to the annex should describe its content. This should include reference to any relevant international reviews ( e.g . those of OECD, IPCS/WHO or IARC) and how this information has been incorporated into the document. For example whether or not the results of an international assessment (toxicological or ecotoxicological) are substantively different from those of the notifying countries should be noted. In the case of mammalian toxicity a summary of the two evaluations highlighting the similarities or differences as appropriate may be included in section 2.2.7 of this annex (see below). The level of detail within the subheadings may be adjusted to accommodate the information used to support the notified regulatory action and available to the drafting group. (See appendix 2 to the present note for a list of the headings and subheadings and an indication of the points that may be included under each.) Specific sections on exposure/risk evaluation have been included for both human health and environmental fate and effects. These sections should include specific information from notifying countries on the basis for their final regulatory action. General comments Tabular summaries of information should be used wherever possible; this should not, however, be at the expense of a clearly stated analysis that explains how the data were used in the risk evaluation that formed the basis for the reported regulatory action. The level of detail will be a function of the information that is available and will need to be determined on a case by case basis. As a guiding principle, however, the focus should be on those end points that were the basis for the risk evaluation underlying the notified final regulatory action. For example, in those instances where a chemical was found to be a reproductive toxin and this was the basis for the regulatory action, greater detail would be expected on the supporting studies e.g . NOEL/NOAEL/LOEL, than on end points for which the results may have been negative ( i.e. , simply stating “was not carcinogenic”). In the case of universally recognized regulatory guidelines or limits such as the acceptable daily intake (ADI) or acute reference dose (ARfD), details on the supporting studies on which they are based should be included. LD 50 and LC 50 data can vary widely for a chemical. In order to avoid apparent discrepancies in the information reported, it may be better to report a range of values wherever possible, particularly where the results from more than one source are combined. In reporting toxicity data reference should be made to the duration of exposure for all studies reported, including acute toxicity studies, where it is available or known. In some cases, the notifying parties may reach different conclusions on individual end points related to human health or the environment. Furthermore, the situation may arise where there has been an evaluation of the chemical at the international level e.g . by the OECD, WHO/IPCS or IARC that has reached conclusions that differ from those of the findings of the notifying parties. In such cases the following approaches should be considered: It is intended that these differences be clearly indicated in the decision guidance document, where they concern “pivotal end points” within the risk evaluation, that is those end points upon which the final regulatory action was based. Where there are differences in interpretation of data concerning specific end points, but the differences do not affect the outcome of the final regulatory action or the conclusions of the international review, the degree to which these details will be reflected in the decision guidance document will need to be considered on a case-by-case basis. Section 2.2.7 Summary of mammalian toxicity and overall evaluation – this section provides an opportunity to summarize the conclusions of the toxicological evaluations from the notifying countries as well as any relevant international reviews e.g . WHO/IPCS/IARC. Where information from an international evaluation such as an IPCS Environmental Health Criteria document is included, the reference in the text should be to this document, rather than to the individual papers quoted therein. Where information from the risk evaluations by the notifying Parties is included, it is sufficient if this source is indicated, rather than the specific studies or reviews referred to. Specific comments - details of proposed subheading may be found in appendix 2 1. Physico-chemical properties This section characterizes the chemical, based on national evaluations and recognized information sources e.g . Pesticides Manual, A World Compendium (Crop Protection Publications - ISBN 0 948404 79 5) 2. Toxicological properties 2.1. General information This section should provide brief information on the mode of action, symptoms of poisonings and on absorption, distribution, excretion and metabolism in mammals. It can be retrieved from the notifications as well as from internationally recognized sources such as the Pesticide Manual or WHO/IPCS/JMPR/IARC evaluations. 2.2 Toxicity studies This section lays out the toxicological profile of the chemical as assessed by the notifying countries at the time of their final regulatory actions(s). It should also include a comparative summary of any IPCS/WHO international evaluations, such as those of WHO/IPCS/JMPR, where they are available and considered relevant. This summary should be included in section 2.2.7 Summary of mammalian toxicity and overall evaluation. In the interests of brevity, where multiple studies for the same end point exist, the drafting group should report in a summary form, rather than report on each individual study. The level of detail will need to be considered on a case-by-case basis. It is generally accepted that where a review document has been used as the source of the information, the review document is cited rather than the individual studies. Under the heading Summary of mammalian toxicity and overall evaluation (section 2.2.7), the drafting group should provide a concise summary of key end points, in order to facilitate comparisons among different evaluations and to improve understanding of those end points considered in the human exposure/risk evaluation section (see the preceding section on General comments). 3. Human exposure/risk evaluation This section highlights in greater detail those human exposure and risk factors that led to the regulatory control action(s), focusing on the major exposure routes ( i.e. food, air, water and occupation). Information concerning epidemiological studies or poisoning incidents that were considered by the notifying country in taking the reported regulatory action could be inserted under the subheading Medical data (section 3.5). Note: Where the reported regulatory actions are based on environmental effects, it is anticipated that this section of the decision guidance document would be minimal. 4. Environmental fate and effects This section provides information on the environmental fate characteristics ( Fate , section 4.1) of the chemical and the results of ecotoxicity studies ( Effects on non-target organisms , section 4.2). Note : Specific subheadings for the parameters of persistence and bio-concentration have been included to facilitate the identification of chemicals with the characteristics of persistent organic pollutants (POPs) . 5 . Environmental exposure/risk evaluation This section highlights in greater detail those environmental fate factors that led to the regulatory control action(s) and should include a summary of the overall risk evaluation. Note: Where the reported regulatory actions are based on human health concerns ( e.g ., risks to workers), it is anticipated that this section of the decision guidance document would be minimal. Annex 2. Details on final regulatory actions reported Annex 2 reports expand upon the information presented regarding the final regulatory action(s) of each notifying country. This annex should reflect the information provided in the notification of regulatory action form and presented to the Chemical Review Committee for review. The annex represents an opportunity for notifying countries to provide increased detail on aspects of the regulatory decision that they may wish to include. Annex 3. Addresses of designated national authorities This annex should provide detailed information on how to contact the designated national authorities of the notifying countries, including the name of a contact person; mailing address; telephone, fax and telex numbers; and email address. Annex 4. References This annex includes a list of the sources of information cited in the decision guidance document. Where information from a review document has been used, the reference should be to the review document, rather than to the individual papers within the review. Original papers should only be cited where they have been considered individually, rather than as a component of the review. List References under headings as appropriate. The following is an example for a reference list: Regulatory actions Decision by the Norwegian Agricultural Inspection Service (NAIS) 22.10.2002 (200200430 IP/hmo). Supporting documentation provided by Country X Environmental Health Criteria No. 165: Inorganic Lead. IPCS/WHO 1995 ( an example of a review document) Supporting documentation provided by Country Y Sebastien P, Begin R, &amp; Masse S (1990) Mass number and size of lung fibres in the pathogenesis of asbestosis in sheep. Int J Exp Pathol, 71: 1-10. (individual paper cited if the original paper was used in the preparation of the DGD) Others WHO (2003): Health Risk of Persistent Organic Pollutants from Long-Range Transboundary Air Pollution. Relevant guidelines and reference documents FAO/WHO Food Standards (2010). CODEX Alimentarius. FAO (2006) Framework of FAO Guidelines on Pesticide Management in support of the Code of Conduct. http://www.fao.org/ag/AGP/AGPP/Pesticid/Code/Guidelines/Framework.htm Appendix I: Standard Core Set of Abbreviations STANDARD CORE SET OF ABBREVIATIONS &lt; less than &lt; less than or equal to &gt; greater than &gt; greater than or equal to µg microgram m micrometre ARfD acute reference dose a.i. active ingredient ADI acceptable daily intake AOEL acceptable operator exposure level b.p. boiling point bw body weight o C degree Celsius (centigrade) CAS Chemical Abstracts Service cc cubic centimetre cm centimetre DNA deoxyribonucleic acid DT 50 dissipation time 50% EC European Community EC 50 median effective concentration ED 50 median effective dose EEC European Economic Community EHC Environmental Health Criteria EU European Union FAO Food and Agriculture Organization of the United Nations g gram h hour ha hectare i.m. intramuscular i.p. intraperitoneal IARC International Agency for Research on Cancer IC 50 median inhibitory concentration ILO International Labour Organisation IPCS International Programme on Chemical Safety IPM Integrated Pest Management IUPAC International Union of Pure and Applied Chemistry JMPR Joint FAO/WHO Meeting on Pesticide Residues (Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and a WHO Expert Group on Pesticide Residues) k kilo- (x 1000) kg kilogram Koc soil organic partition coefficient Kow octanol–water partition coefficient kPa kilopascal L litre LC 50 median lethal concentration LD 50 median lethal dose LOAEL lowest-observed-adverse-effect level LOEL lowest-observed-effect level m metre m.p. melting point mg milligram ml millilitre mPa millipascal MRL maximum residue limit MTD maximum tolerated dose ng nanogram NOAEC no-observed-adverse-effect concentration NOAEL no-observed-adverse-effect level NOEC no-observed-effect concentration NOEL no-observed-effect level OECD Organisation for Economic Co-operation and Development PEC predicted environmental concentration Pow octanol-water partition coefficient, also referred to as Kow PPE personal protective equipment ppm parts per million (used only with reference to the concentration of a pesticide in an experimental diet. In all other contexts the terms mg/kg or mg/L are used). RfD reference dose (for chronic oral exposure; comparable to ADI) SMR standard(ized) mortality ratio STEL short-term exposure limit TER toxicity exposure ratio TLV threshold limit value TWA time-weighted average UNEP United Nations Environment Programme USEPA United States Environmental Protection Agency UV ultraviolet VOC volatile organic compound w/w weight for weight WHO World Health Organization wt weight Appendix 2: Headings for Annex I and a list of information points that could be included under each Physico-chemical properties Toxicological properties General Mode of action Symptoms of poisoning Absorption, distribution, excretion and metabolism in mammals Rate and extent of absorption Distribution Potential for accumulation Rate and extent of excretion Metabolism in animals Toxicologically significant compounds (animals, plants and environment) 2.2. Toxicology studies 2.2.1. Acute toxicity Rat LD 50 oral Rat LD 50 dermal Rat LC 50 inhalation Skin irritation Eye irritation Skin sensitization (test method used and result) 2.2.2. Short term toxicity Target /critical effect Oral Dermal Inhalation 2.2.3. Genotoxicity (including mutagenicity) 2.2.4. Long term toxicity and carcinogenicity Target /critical effect Relevant NOAEL/NOEL Carcinogenicity 2.2.5. Effects on reproduction Reproduction target/critical effect Lowest relevant reproductive NOAEL/NOEL Developmental target/critical effect Lowest relevant developmental NOAEL / NOEL 2.2.6. Neurotoxicity/delayed neurotoxicity Acute neurotoxicity Subchronic neurotoxicity Special studies (where available) could include human immunotoxicity studies 2.2.7. Summary of mammalian toxicity and overall evaluation include summary of key findings of relevant international reviews e.g . WHO/IPCS/IARC evaluations Human exposure/risk evaluation 3.1. Food 3.2. Air 3.3. Water 3.4. Occupational 3.5. Medical data contributing to regulatory decision – could include: Report on medical surveillance on manufacturing plant personnel Report on clinical cases and poisoning incidents Observations on exposure of the general population and epidemiological studies Environmental fate and effects 4.1. Fate 4.1.1. Soil Field dissipation Aerobic and anaerobic degradation Rate of degradation Adsorption/desorption Mobility 4.1.2. Water Route and rate of degradation 4.1.3. Air Fate and behaviour 4.1.4. Bioconcentration and bioaccumulation 4.1.5. Persistence 4.2. Effects on non-target organisms 4.2.1. Terrestrial vertebrates Acute/chronic toxicity mammals Acute/chronic toxicity birds Dietary toxicity birds Reproductive toxicity birds Other 4.2.2. Aquatic species Fish Invertebrates Algal species Aquatic plants Other 4.2.3. Honey bees and other arthropods 4.2.4. Earthworms 4.2.5. Soil microorganisms 4.2.6. Terrestrial plants 5. Environmental exposure/risk evaluation Specific reference as appropriate to the following 5.1. Terrestrial vertebrates Mammals/birds 5.2. Aquatic species Fish/invertebrates/algal species/aquatic plants 5.3. Honey bees Other arthropods 5.4. Earthworms 5.5. Soil microorganisms 5.6. Summary – overall risk evaluation. ROTTERDAM CONVENTION Secretariat of the Rotterdam Convention Secretariat of the Rotterdam Convention United Nations Environment Programme Food and Agriculture Organization of the United Nations Office Address: International Environment House 1 Viale delle Terme di Caracalla, 00153 Rome, Italy 11–13, chemin des Anémones, 1219 Châtelaine, Geneva, Switzerland Tel.: +39 06 5705 2061 ¦ Fax: +39 06 5705 3224 ¦ E-mail: [email protected] Postal Address: c/o Palais des Nations, 8-14, avenue de la Paix, 1211 Geneva 10, Switzerland Tel.: +41 (0) 22 917 8271 ¦ Fax: +41 (0) 22 917 8098 ¦ E-mail: [email protected] Date: 16 February 2024 Subject: Invitation for comments on the draft decision guidance document for mercury being prepared by the Chemical Review Committee of the Rotterdam Convention Dear Sir, Dear Madam, I am pleased to inform you that at its nineteenth meeting held from 3 to 6 October 2023 in Rome, the Chemical Review Committee adopted six decisions contained in annex I to the report of the meeting (UNEP/FAO/RC/CRC.19/14). The report has been made available on the Rotterdam Convention’s website: www.pic.int/crc19. The twelfth meeting of the Committee is scheduled to take place in Rome from 17 to 20 September 2024, back to back with the twentieth meeting of the Persistent Organic Pollutants Review Committee of the Stockholm Convention. In decision CRC-19/4, the Committee concluded that the notifications of final regulatory action for mercury submitted by Colombia and the European Union met the criteria set out in Annex II to the Convention and adopted the rationale for the Committee’s conclusion. The Committee recommended, in accordance with paragraph 6 of Article 5 of the Convention, that the Conference of the Parties list mercury in Annex III to the Convention as an industrial chemical. The Committee further decided to develop a draft decision guidance document for mercury and established an intersessional drafting group for this purpose. Following the agreed workplan, the intersessional drafting group has prepared a draft decision guidance document, enclosed in this letter, for review and comments by the Chemical Review Committee members and observers. Please review the draft decision guidance document for mercury and submit your comments to the Secretariat by 19 March 2024. The comments should be submitted to the Secretariat by e-mail to: Ms. Kei Ohno Woodall ([email protected]). Should you require additional information or clarification, please do not hesitate to contact the Secretariat by e- mail. Yours sincerely, Rolph Payet Executive Secretary Encl. Draft decision guidance document for mercury To: Chemical Review Committee members and observers Cc: Representatives of permanent missions to the United Nations Office at Geneva Saatja: "Kei Ohno Woodall" <[email protected]> Saaja: "Kei Ohno Woodall" <[email protected]> Teema: Rotterdam Convention: Invitation for comments on the draft DGD for mercury by 19 March 2024 Kuupäev: 2024-02-19 19:59 Dear Sir/Madam, Please find attached a letter inviting comments on the draft decision guidance document for mercury, prepared by the intersessional drafting group established by the Rotterdam Convention Chemical Review Committee. The nineteeth meeting of the Chemical Review Committee was held from 3 to 6 October 2023. The meeting report is available on the Convention’s website <http://www.pic.int/crc19> . At the meeting, the Committee adopted decision CRC-19/4, by which it adopted the rationale for the Committee’s conclusion that the notifications of final regulatory action submitted by Colombia and the European Union in respect of mercury in the industrial category met the criteria of Annex II to the Convention and recommended that the Conference of the Parties list mercury in Annex III to the Convention as an industrial chemical. In accordance with the workplan adopted at the meeting, the intersessional drafting group has prepared a draft decision guidance document for mercury. The Chemical Review Committee members and observers, inlcuding Parties to the Convention, are invited to review the attached draft and submit comments by e-mail to the Secretariat at [email protected] <mailto:[email protected]> by 19 March 2024. For your reference, the working paper on preparing internal proposals and decision guidance documents for banned and severely restricted chemicals is also attached. If you have any questions regarding this invitation, please contact the Secretariat. Kind regards, Kei --- Kei Ohno Woodall Secretariat of the Basel, Rotterdam and Stockholm Conventions United Nations Environment Programme Office address: 11-13, chemin des Anémones, 1219 Châtelaine, Genève, Switzerland Postal address: c/o Avenue de la Paix 8-14, 1211 Genève 10, Switzerland Tel.: +41 22 506 85 22 Email: <mailto:[email protected]> [email protected]