EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 re levance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 U nion,  
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, ame nding 
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/EC1, and in particular Arti cle 
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 respec t 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 -Eurasi an Migratory Waterbirds2 (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 Council3 
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 occu rring 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 compound s 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 
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2 https://www.unep -aewa.org/sites/default/files/basic_page_documents/agreement_text_english_final.pdf  
3 Directive 2009/147/EC of the European Pa rliament and of the Council of 30 November 2009 on the 
conservation of wild birds (OJ L 20, 26.01.2010, p.7).  EN 2  EN 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 dossier4 proposing  the 
introduction of a restriction on the use of lead and lead compounds in gu nshot 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 po ssession of 
lead gunshot in wetlands  in order to enhance enforceability of the proposed restriction 
on the use of lead gunshot for shooting . The Agency  concluded that the use of lead 
gunshot in  wetlands le ads to a risk to waterbirds that ingest spent lead gunshot, leadin g 
to toxicological effects, including death .  
(6) The number of water birds estimated to die in the Union from lead poisoning  is in the 
order of  one million  every year . The use of lead gunshot also leads to a risk t o species 
that feed on  birds co ntaminated 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 
envir onmental 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) Legislation preventing or reducing the use of lead gunshot in wetlands exist s in the 
majority of Member States , but the disparities between them result in different levels 
of risk reduction.  The Annex XV dossier demonstrated that Union -wide action is 
necessary to address the risks  arising from the use of lead gunshot in wetlands  in a 
harmonised manner . 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 . 
(9) The Agency suggested a transitional 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 tha t opinion , RAC concurred with the Agency’s conclusion that 
ingestion of spent lead gunshot by waterbirds caus es 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 risk s. 
(11) RAC strongly supported  a shorter transitional 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 . 
                                                 
4 https://echa.europa.eu/documents/10162/6ef877d5 -94b7 -a8f8-1c49 -8c07c894fff7  EN 3  EN (12) On 14 June 2018, the Agency’s  Committee for  Socio -economic 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 socio -economic 
benefits of the measure would be proportionate to the socio -economic 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 transition al 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, that infrastructure for proofing gunshots is available in nearly all 
Member States and that, in terms of increased costs for early replacement of guns, a 
shorter transition al period wou ld have only a minor impact . 
(14) The Forum for Exchange of Information on Enforcement  was consulted during the  
restriction s process  in accordance with Article 77(4)(h) of Regulation (EC) No 
1907/2006  and its recommendations were taken into account . 
(15) On 17 Augus t 2018, the Agency submitted the opinions of RAC and SEAC5 to the 
Commission.  
(16) Taking into account the Annex XV dossier , the opinions of RAC and SEAC, the 
socio -economic impact and the availability of alternatives, the Commission considers 
that t here is an unacceptable risk to the environment and a potential  risk to human 
health  stemming from the discharge  of lead gunshot in or around wetlands , which  
needs to be  addressed on a Union -wide basis . It is therefore appropriate to introduce a 
restriction on the act of discharging lead gunshot in or around wetlands.  
(17) Given the difficulty for enforcement authorities in catching hunters in the act of 
actually discharging gunshot, t he Commission agrees wi th the Agency that the 
restriction should also include the act of being in possession of lead gunshot . This will 
make it possible to enforce the restriction on discharging gunshot  far more effectively 
and will therefore ensure the effectiveness of the restriction in addressing the risks 
identified to the environment and human health.  
(18) As noted in the RAC and SEAC opinions, a restriction on being in possession of lead 
gunshot should, however, apply specifically to possession whilst shooting, as opposed 
to po ssession in some other context, for example when transporting gunshot across 
wetlands for delivery elsewhere. The Commission considers , moreover, that the 
restriction on possession should be directly linked to the particular type of shooting 
within the sco pe of the restriction (shooting  in or around wetlands ). This is  in view of 
the fact that  comments submitted during the public consultation on the Annex XV 
dossier  indicated that , in some Member States, hunters involved in other types of 
shooting are quite likely to walk through different types of terrain, wetlands as well as 
other terrains, on a typical day’s shooting. The Commission also considers that , in 
order to aid enforcement, the restriction on possession should cover not only 
possession while out wetland shooting, but also possession as part of going wetland 
shooting , in other words where there is a close connection with the actual shooting. 
                                                 
5 https://echa.europa.eu/documents/10162/b092e670 -3266 -fb5d-6296 -544eaccb5d4a  EN 4  EN This would cover , for example , possession while heading out on, or returning home 
from , a day’s wetland shooti ng or possession by someone helping hunters on a 
shooting expedition . 
(19) Given the practical difficulties in proving the particular type of shooting that a person 
found in possession of lead gunshot is intending to do, it is appropriate to establish a 
legal p resumption that anyone found  in or around wetlands in possession of lead 
gunshot while out shooting, or as part of going shooting, is presumed to be in 
possession of that gunshot while out wetland shooting, or as part of going wetland 
shooting. In other words, it would be for that person to show that he or she was 
actually intending to go shooting elsewhere and was merely passing through the 
wetland area in order to go shooting elsewhere . 
(20) As regards geographical scope, t he Agency proposed that the restric tion on 
discharging lead gunshot should apply not only in wetlands but also in areas where 
“spent gunshot would land within a wetland”. The Commission notes that there was 
some support in RAC for quantitatively defining a fixed buffer zone around wetlands 
(of, say, 300 metres) rather than relying on a test based on where spent gunshot would 
land. The Commission agrees that a fixed buffer zone is likely to make it easier to 
enforce the restriction. The restriction should therefore apply to discharging lead 
gunshot not only in wetlands but also in a fixed buffer zone around wetlands, defined 
quantitatively. Given the nature of the identified risks to the environment and human 
health, the Commission considers it appropriate to proceed on the side of caution in 
setting the size of the buffer zone. The Commission notes that, during the public 
consultation on the Annex XV dossier , the German Environment Agency suggested 
that a safety zone of at least 500 metres around wetlands should be established to 
address the r isk of lead gunshot flying into and contaminating wetlands . The 
Commission also notes that  legislation in the German state of Mecklenburg -
Vorpommern prohibits the use of lead gunshot in a buffer zone of 400 metres 
enclosing all types of wetland . In view of  these comments and considerations, the size 
of the fixed buffer zone should be set at 400 metres around wetlands.  
(21) The Agency proposed that the restriction on being in possession of lead gunshot 
should be confined to possession actually in wetlands. RAC  noted in its opinion that a 
prohibition also on possession in the fixed buffer zone around wetlands could improve 
enforcement . In view of the enforcement advantages and effectiveness of the 
restriction  as a result of not having to catch hunters in the actual  act of discharging 
lead gunshot, the Commission considers it appropriate to apply the restriction on being 
in possession of lead gunshot not only to possession in wetlands but also to possession 
in the fixed buffer zone  around wetlands . 
(22) As gunshot is generally not designed or placed on the market specifically  or 
exclusively  for use in or around wetlands , a restriction on the placing on the market of 
lead gunshot would  affect shooting in all terrains . Therefore, the restriction should be 
limited  to the discharge  and being in possession  of lead gunshot . 
(23) The restriction should apply to gunshot containing a concentration of lead equal to or 
greater than 1%. 1% is the concentration limit applied for the purposes of the  “non -
toxic” gunshot approval pr ocess in the United States of America in order to avoid a 
significant toxicity danger to migratory birds and other wildlife, or their habitats . 
Moreover , a 1% concentration threshold for the restriction is considered to be 
sufficient to address the risks posed by lead -containing shot material whilst also being EN 5  EN readily achievable by producers of alternative gunshot, given that some of those 
alternatives are likely to contain lead as an impurity . 
(24) It is appropriate to mirror the definition of “wetlands ” used in the Convention on 
Wetlands of International Importance (Ramsar Convention ) signed in Ramsar  on 2 
February 1971  for the purposes of the restriction , as was propo sed by the Agency  and 
confirmed in the opinions of RAC and SEAC , since  that definition i s comprehensive, 
covering all types of wetlands (including  peatlands , where many waterbirds are also 
found , and since  the Ramsar Convention has also developed a classification system for 
wetland types to help in the identification of wetlands . 
(25) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with the restriction and Member States should be allowed sufficient time to prepare for 
its enforcement . Taking into account the views expressed by RAC and SEAC  
regarding  the feasibility and appropriateness of a shorter transitional period than the 
three years proposed by the Agency , and taking account particularly of the estimated 
impact each year of introducing more lead into wetlands through the use of lead 
gunshot, application of the restriction should be deferred for only 18 months . 
(26) In September 2018, the Agency published the results of an investigation report6 
reviewing the available information on various uses of lead including, among other  
thing s, in shot used in te rrestrial environments. Since the investigation report found, 
inter alia,  that the available information suggest ed that the use of lead gunshot in 
terrestrial areas posed a risk to both human health and the environment , the 
Commission requested the Agency in 201 9 to prepare an Annex XV dossier  with a 
view to a possible restriction on  the placing on the market and use  of lead in 
ammunition and in fishing tackle7. 
(27) Moreover, i n their opinions  on the Annex XV dossier on the use of lead gunshot for 
shooting in w etlands , RAC and SEAC indicated their agreement with the Agency’s 
view that a ban on the placing on the market and use of lead gunshot in all terrains 
would result in a higher level of environmental protection and would be more effective 
from the point of view of p racticality and enforceability.  
(28) In some Member States , the restriction introduced by this Regulation may give rise to 
particular difficulties due to the specific geographical conditions in that Member State. 
For Member States with a significant pr oportion of wetlands in their territory, a ban on 
discharging and being in possession of lead gunshot in and around wetlands could in 
practice have a similar effect to a total ban on all shooting across the whole territory  
since hunters of all kinds would almost inevitably find themselves frequently in or 
near wetlands . Moreover, the resources that would have to be devot ed to t he 
enforcement of a restriction targeted only at areas in and around wetlands may not be 
much smaller , and may indeed be greater , than the resources needed to enforce a 
restriction covering their territory as a whole.  
(29) Given the difficulties described in the preceding recital , the need for the measure to be 
not only effective, but also simple and fair on the hunting community as a whole , and 
also the results of the Agency’s investigation report and the views of RAC and SEAC 
summarised in recital (27), the Commission considers that those Member States where 
                                                 
6 https://echa.europa.eu/documents/10162/13641/lead_ammunition_investigation_report_en.pdf  
7 https://echa.europa.eu/documents/10162/13641/rest_lead_ammunition_COM_request_en.pdf/f607c957 -
807a -3b7c -07ae -01151001d939  EN 6  EN such difficulties are likely to arise should be given the option to impose a diffe rent 
restriction  in their territory  which would prohibit both the placing on the market of 
lead gunshot, and also the discharging  and being in possession  of lead gunshot  
throughout  their territory , whether in wetlands or elsewhere , in connection with any 
type of shooting . 
(30) In the interests of legal certainty, it is important to identify clearly the Members States 
who are to be eligible to make use of that option if they want. The option should be 
available to those Member States where at least 20% of their territory is made up of 
wetland areas. A 20% threshold equates broadly speaking to those Member States who 
are likely to experience the dif ficulties described in recital (28). 
(31) Since the restriction that could be imposed by those Member States making use of  the 
option would be more stringent  than the one limited to areas in and around wetlands , it 
is appropriate to set a longer transitional period for the introduction of that restriction. 
That longer transitional period should be set at 36 months , which corr esponds to the 
transitional period originally suggested by the Agency in the Annex XV dossier .  
(32) For reasons of transparency and legal certainty, the Member States making use of the 
option should be required to notify  the Commission of their intention and to 
communicate  the measures adopted by them to give effect to it  within certain 
deadlines , and the Commission should make  the notices of intention as well as copies 
of the adopted national measures  publicly available  without delay . 
(33) Regulation (EC) No 1907/2006 should therefore be amended accordingly . 
(34) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established by Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVI I to Regulation (EC) No 1907/2006 is amended in accordance wit h the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regula tion shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker