Commission Regulation (EU) 2021/57 of 25 January 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlands (Text with EEA relevance)

• Celex Number: 32021R0057
• ELI: http://data.europa.eu/eli/reg/2021/57/oj
• Published date: 26 January 2021
• Date: 25 January 2021
• Date of Signature: 25 January 2021
• Official Gazette Publication: Official Journal of the European Union, L 024, 26 January 2021

26.1.2021 EN Official Journal of the European Union L 24/19

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COMMISSION REGULATION (EU) 2021/57

of 25 January 2021

amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlands

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(1) thereof,

Whereas:

(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.

(2) The Union and 23 Member States are Contracting Parties to the Agreement on the Conservation of African-Eurasian Migratory Waterbirds (2) (AEWA). Contracting Parties are required under paragraph 4.1.4 of the Action Plan annexed to AEWA to endeavour to phase out the use of lead shot for hunting in wetlands as soon as possible in accordance with self-imposed and published timetables.

(3) Article 4(2) of Directive 2009/147/EC of the European Parliament and of the Council (3) requires Member States to pay particular attention to the protection of wetlands, and particularly to wetlands of international importance, in the taking of conservation measures with regard to regularly occurring migratory species.

(4) On 3 December 2015, the Commission asked the European Chemicals Agency (‘the Agency’) pursuant to Article 69(1) of Regulation (EC) No 1907/2006 to prepare a dossier with a view to extending the restriction on lead and lead compounds in Annex XVII to that Regulation in order to control the risk to the environment and human health posed by the use of lead or lead compounds in gunshot used for shooting in wetlands (‘the Annex XV dossier’). At the same time, the Commission also asked the Agency to start collecting information on other uses of lead ammunition, including hunting in terrains other than wetlands and target shooting, and on the use of lead weights for fishing.

(5) On 21 June 2017, the Agency published the Annex XV dossier (4) proposing the introduction of a restriction on the use of lead and lead compounds in gunshot for shooting with a shotgun within a wetland or where spent gunshot would land within a wetland. The Agency also proposed introduction of a restriction on the possession of gunshot containing a concentration of lead equal to or greater than 1 % (‘lead gunshot’) in wetlands in order to enhance enforceability of the proposed restriction on the use of lead in gunshot for shooting. The Agency concluded that the use of lead in gunshot in wetlands leads to a risk to waterbirds that ingest spent lead gunshot, leading to toxicological effects, including death.

(6) The number of waterbirds estimated to die in the Union from lead poisoning is in the order of one million every year. The use of lead in gunshot also leads to a risk to species that feed on birds contaminated with lead gunshot, and a risk to humans from consuming waterbirds shot with lead gunshot, although the latter risk was assessed by the Agency only qualitatively. Exposure to lead by humans is associated with neurodevelopmental effects, impaired renal function and fertility, hypertension, adverse pregnancy outcomes and death.

(7) The Agency concluded that lead-free gunshot alternatives, such as steel and bismuth gunshot, are widely available, technically feasible and have better human health and environmental hazard and risk profiles than lead gunshot. Moreover, steel gunshot, the most likely alternative to be used, is available at a comparable price to that of lead gunshot.

(8) Provisions prohibiting or restricting the use of lead in gunshot in wetlands exist in the majority of Member States, but the disparities between them result in different levels of risk reduction. Furthermore, the migration routes of migratory birds typically cross several Member States and therefore birds could ingest spent lead gunshot in Member States where no or more limited measures are in place. The Annex XV dossier demonstrated that Union-wide action is necessary to address the risks arising from the use of lead in gunshot in wetlands in a harmonised manner. Harmonisation legislation should however be based on a high level of protection. The outcome of harmonisation should therefore not be to oblige the Member States that have stricter national provisions on lead in gunshot to abandon those provisions, as this would imply a reduction in the level of protection of environment and health in those Member States.

(9) The Agency suggested a period of three years for introduction of the restriction.

(10) On 9 March 2018, 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 that opinion, RAC concurred with the Agency’s conclusion that ingestion of spent lead gunshot by waterbirds causes toxicological effects, including death. As to human health, RAC concluded that lead is highly toxic and that no threshold has been established either for neurodevelopmental effects in children or for blood pressure or renal effects in adults, so any exposure to lead therefore constitutes a risk. RAC concluded that the proposed restriction is an appropriate Union-wide measure to address the identified risks.

(11) RAC strongly supported a shorter period than the three years proposed by the Agency. The reason given was that each year of delay would result in approximately 4 000 additional tonnes of lead being released into wetland areas, resulting in the death of somewhere in the order of 1 million birds.

(12) On 14 June 2018, the Agency’s Committee for Socioeconomic Analysis (SEAC) adopted an opinion pursuant to Article 71(1) of Regulation (EC) No 1907/2006, concluding that the proposed restriction is an appropriate Union-wide measure to address the identified risks, taking into account the fact that the socioeconomic benefits of the measure would be proportionate to the socioeconomic costs. In addition, SEAC concluded that the cost of the proposed restriction would be borne mainly by hunters, and that the cost increase to hunters was reasonable.

(13) SEAC considered that a shorter period than the three years suggested in the Annex XV dossier could pose a challenge in terms of implementation for those Member States that currently have only a limited or no ban on the use of lead gunshot in wetlands, although SEAC did also acknowledge that a shorter transitional period might be feasible, having regard to the fact that lead-free gunshot is already available on the market and that, in terms of increased costs for early replacement of guns, a shorter period would have only a minor impact.

(14) The Forum for Exchange of Information on Enforcement was consulted during the restrictions process in accordance with Article 77(4)(h) of Regulation (EC) No 1907/2006 and its recommendations were taken into account.

(15) On 17 August 2018, the Agency submitted the opinions of RAC and SEAC (5) to the Commission.

(16) Taking into account the Annex XV dossier, the opinions of RAC and SEAC,

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