(fra kommisjonsforordningen)

(1)    Annex XVII to Regulation (EC) No 1907/2006 lays down restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles. Entry 63 of that Annex contains restrictions with respect to lead (CAS No 7439-92-1, EC No 231-100-4) and lead compounds (‘lead’), including a restriction on lead in gunshot in or around wetlands that was introduced by Commission Regulation (EU) 2021/57 .

(2)    Lead is classified under Regulation (EC) No 1272/2008   as very toxic to aquatic life, and toxic for reproduction, due to its adverse effects on fertility and the development of the nervous system of the foetus and the child, leading to permanent damage and intelligence quotient (IQ) loss. No safe lead-concentration threshold has been identified under which lead has no ill effects on human health. Lead is also associated with an increased risk of cardiovascular, kidney and central-nervous-system diseases in adults. Moreover, exposure to lead can have a range of acute and chronic toxicological effects, including death, in animals, particularly in birds  . 

(3)    The Union and its Member States are Contracting Parties to the Convention on the Conservation of Migratory Species of Wild Animals   (CMS). The Preventing Poisoning Working Group (PPWG) developed Guidelines to Prevent the Risk of Poisoning to Migratory Birds (‘Guidelines’), which were adopted in 2014 by CMS Resolution 11.15. The Guidelines recommend both the phasing-out of the use of lead in ammunition across all habitats and the phasing-out of the use of lead in fishing weights in areas where migratory birds have been shown to be particularly at risk of lead poisoning.

(4)    On 16 July 2019, the Commission asked   the European Chemicals Agency (‘the Agency’), pursuant to Article 69(1) of Regulation (EC) No 1907/2006, to prepare a dossier (‘the Annex XV dossier’) to address the concerns regarding human health and the environment posed by lead in (i) ammunition, including gunshot used in terrains other than wetlands and bullets used both in wetlands and in terrains other than wetlands and (ii) fishing tackle. The mandate did not extend to uses of ammunition for indoor shooting, or to uses by the police, the military and other security forces.

(5)    On 24 March 2021, the Agency published its Annex XV dossier   in which it concluded that lead in ammunition and fishing tackle poses a risk to the environment and human health, in particular to vulnerable populations such as children, that is not adequately controlled and needs to be addressed on a Union-wide basis. With regard to the risk to the environment, the ingestion by birds and other animals of unrecovered lead-based ammunition (‘lead ammunition’), lead-based sinkers (‘lead sinkers’) and lead-based lures (‘lead lures’) from hunting, sports shooting and fishing activities results in the poisoning and frequent death of animals. Furthermore, lead accumulation at sports-shooting ranges can result in the leaching of lead-polluted surface water into local watercourses and may affect groundwater, potentially poisoning people, livestock and wildlife. The Agency also concluded that there are human health risks associated with consuming the meat of animals killed with lead ammunition, particularly for children aged seven years and younger, or when making lead ammunition or sinkers or lures at home. 

(6)    The Agency estimated that, if the current releases of lead from shooting and fishing in the Union continue, approximately 876 000 tonnes of lead will be released into the environment over the next 20 years. This will place at least: (i) 135 million birds at risk of poisoning from the ingestion of lead-based gunshot (‘lead gunshot’); (ii) 14 million birds at risk of poisoning from the ingestion of lead via the consumption of food; and (iii) 7 million birds at risk of poisoning from ingestion of sinkers and lures. In addition, the Agency estimated that, each year, about 13.8 million individuals from hunters’ families, including 1.1 million children aged seven years or younger, are vulnerable to lead exposure from game meat.

(7)    Against this background, the Agency proposed a restriction of lead in ammunition and certain fishing tackle which included, inter alia, a restriction on the placing on the market and use of lead in a concentration of equal to or greater than 1% in gunshot, and a restriction on the use of lead in a concentration of equal to or greater than 1% in projectiles other than gunshot (such as bullets and airgun pellets). Moreover, the Agency proposed imposing information obligations on retailers of those products and labelling obligations on ammunition suppliers. The proposed restriction is intended to reduce lead emissions by approximately 630 000 tonnes over the 20 years following its introduction. This would be a reduction of 72% compared with a situation without the proposed restriction. The restriction would also prevent IQ loss in about 7 000 children in the Union per year, leading to a welfare saving of roughly EUR 70 million per year.

(8)    In its Annex XV dossier, the Agency concluded that alternative ammunition for hunting (such as steel and bismuth gunshot, and copper and brass bullets): (i) are widely used; (ii) are technically feasible; (iii) are comparable in price with lead ammunition; and (iv) have better human health and environmental hazard and risk profiles than lead ammunition. On sports shooting with gunshot, the Agency found that it would be feasible to substitute steel for lead while maintaining a comparable performance, but that such a shift would require the approval of the relevant international sports-shooting federations. By contrast, alternatives for lead-based bullets (‘lead bullets’) and lead-based airgun pellets (‘lead pellets’) in sports shooting were not found to perform as well as lead. The Agency noted that lead is currently difficult to replace in certain applications, such as small-calibre centrefire ammunition, rimfire ammunition, airgun ammunition, ammunition for muzzle-loading rifles, full metal jacket bullets and open tip match bullets.

(9)    The Agency recommended to defer the entry into application of the restrictions on other articles within the scope of the Annex XV dossier and the information and labelling obligations. This would allow operators to adapt to the new rules and put in place the necessary risk management measures. The Agency proposed a five-year transitional period for the ban on placing on the market and use of gunshot for hunting. It proposed a deferred application period for the ban on the use for hunting of large-calibre and small-calibre projectiles other than gunshot of 18 months and five years respectively.

(10)    The Agency suggested a derogation from the ban on the use of lead bullets for sports shooting, on condition that specific risk management measures are implemented at sports shooting ranges and no agricultural activity takes place there. The Agency also did not support optional derogations from the ban on the placing on the market and the use of lead gunshot in sports shooting. The Agency supported a ban on the use of lead gunshot for sports shooting, but also included the derogations as optional and assessed their costs and benefits in the event that the Commission did not consider such a ban appropriate and required an assessment of the impact of allowing the continued use of lead gunshot for sports shooting under conditions that would minimise the identified risks to human health and the environment. The conditions for the optional derogation included: (i) the licensing of sports shooters by Member States; (ii) the authorising of sports-shooting ranges by Member States; (iii) frequent recovery of more than 90% of the lead gunshot discharged in the shooting range; (iv) the presence of strict measures for the protection of water from lead contamination, and remediation from such contamination; (v) a ban on any agricultural activity in the shooting range; (vi) records of compliance with conditions (iii) to (v); (vii) the labelling of cartridge packaging and of individual cartridges with warning statements; and (viii) a requirement on Member States to report to the Commission the number of licensed users, authorised shooting ranges and quantity of lead gunshot used on their territory.

(11)    The Agency indicated that the restriction should not apply to indoor shooting, uses by police and the military, and uses for security purposes, as indicated in the Commission request to the Agency of 16 July 2019, as well as uses related to testing, development, research and investigation. 

(12)    Following the public consultation on the Annex XV dossier, the Agency revised  its initial proposal to take into account the comments received during the consultation. In particular, it proposed an increase in the permissible concentration limit for lead in projectiles other than gunshot containing copper or copper alloys from less than 1% to less than 3% by weight. This was proposed to allow the continued use of alternative ammunition made of brass (a copper alloy), which currently contains up to 3% lead. The revised Annex XV dossier also included additional derogations for seal hunting with bullets and for hunting with full metal jacket bullets, under certain conditions.  

(13)    Only a limited number of Member States currently have national provisions in place that prohibit the use of lead in hunting and outdoor shooting to reduce lead emissions and exposure. The Annex XV dossier demonstrated that Union-wide action to address the risk associated with lead in ammunition is necessary to ensure a harmonised level of protection across the Union.

(14)    On 2 June 2022, the Agency’s Committee for Risk Assessment (RAC) adopted an opinion pursuant to Article 70 of Regulation (EC) No 1907/2006 with respect to the Annex XV dossier. In its opinion, RAC concurred with the Agency’s conclusion that the use of lead ammunition, including gunshot, in hunting and outdoor shooting poses a wide range of risks to both human health and the environment. RAC concluded that the restriction proposed by the Agency would be the most appropriate Union-wide measure to address the identified risks.

(15)    RAC strongly supported a shorter transitional period than the five years proposed by the Agency for the restriction on the use of gunshot in hunting because the use of lead gunshot in wetlands is already regulated in the Union as a whole and because the shorter the transitional period is, the less lead is released into the environment.

(16)    RAC did not support the optional derogations for the placing on the market of lead gunshot and for the use of lead gunshot for sports shooting. It considered that the enforcement of the proposed restriction, as well as the restriction on lead in gunshot in or around wetlands introduced by Commission Regulation (EU) 2021/57, would increase in complexity if those optional derogations were introduced. However, should those derogations be granted, RAC indicated that it would support the suggestion by the Agency’s Committee for Socio-Economic Analysis (SEAC) that their scope should be limited to shot sizes between 1.9 and 2.6 mm. 

(17)    RAC supported the labelling and information requirements proposed by the Agency for lead ammunition. However, RAC recommended avoiding confusion by increasing the lead concentration limit that would trigger the requirements from 0.3% to 1% by weight, so as to align it with the concentration limit that triggers the ban on placing on the market and use.

(18)    On 1 December 2022, RAC adopted a supplementary opinion, at the request of the Agency’s Executive Director and in accordance with Article 77(3), point (c), of Regulation (EC) No 1907/2006  . This opinion reassessed RAC’s evaluation of a specific dataset concerning the presence of lead in game meat and the human intake of game meat provided by the European Food Safety Authority. RAC reiterated its conclusion that there is a moderate to high risk from exposure to lead in game meat for children in hunter families but that risks for adults are likely to be low.

(19)    On 2 December 2022, SEAC adopted an opinion pursuant to Article 71(1) of Regulation (EC) No 1907/2006. It concluded that the proposed restriction would be the most appropriate Union-wide measure to address the identified risks as concluded by RAC, provided that the conditions are modified as proposed by SEAC. The conclusion takes into account the proportionality of the socio-economic benefits of the measure to its socio-economic costs. 

(20)    SEAC supported RAC’s view that, for the restriction on the use of lead gunshot in hunting, a transitional period significantly shorter than the five years proposed by the Agency would be justified because there is insufficient evidence that increasing the production volumes of alternative ammunition to replace lead gunshot in hunting would require five years. The available information supported the argument that the volumes of lead gunshot used for hunting could be replaced sooner. Substantive and credible evidence to reach a conclusion on the specific length of the transitional period was not available to SEAC, so it considered that the minimum period required to ensure the smooth transition to alternatives would be 18 months.

(21)    In order to make it easier to enforce the ban on the use of lead gunshot while hunting, SEAC recommended a ban on the carrying of such gunshot while hunting or as part of going hunting. 

(22)    In order to maximise the effectiveness of the proposed restriction, SEAC suggested limiting the optional derogations for lead gunshot for sports shooting to shot sizes between 1.9 and 2.6 mm because those are the shot sizes used for that activity. 

(23)    Regarding the ban on the use of lead ammunition in muzzle loaders or other historic firearms, SEAC noted that non-lead alternatives are not yet available for use in historic firearms. It nevertheless considered that a conclusion on whether a derogation for that use would be justified on the basis of cultural values, as had been suggested during the public consultation, would not be possible due to a lack of information on the socio-economic impacts of such a derogation. 

(24)    SEAC did not have sufficient information to reach a conclusion as to whether the cost of providing information at the point of sale as proposed by the Agency and supported by RAC would be fully justified, or whether other educational measures could more effectively influence purchasing behaviour. SEAC agreed with RAC that the same concentration limit of 1% by weight proposed for restricting the placing on the market and use of lead ammunition should also apply to labelling and information the restriction on ammunition containing a concentration of lead equal to or greater than 1% by weight. 

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