National, international and EU law and the regulation of lead in hunting ammunition
Regulations on lead shot
Denmark was a pioneer in regulating lead shot used for hunting (details and lessons learned are described by ). The USA and Norway enacted laws requiring the use of lead-free shot over wetlands in 1991. Since then, an increasing number of countries have enacted similar restrictions to the same conservation end . California required the use of gunshot for all hunting from 2019 onward . The national approaches to regulating hunters’ lead shot in Europe are as follows: the Netherlands (since 1993) and Denmark (since 1996) have a total ban of lead gunshot use in all types of habitats; 16 members states have a total ban in wetlands and/or for waterbird hunting; and 5 have a partial ban implemented only in some wetlands [24, 26] (Table 2).
Regulations on lead bullets
California is currently the only country which has banned lead in rifle bullets used for hunting , while Mauritania prohibits all forms of lead ammunition since 1975 for large game and sport hunting . In Europe the use of lead-based rifle bullets is regulated only in some regions, sites or National Parks in Germany, Italy and Spain in order to avoid contamination of game meat and/or to protect raptors from lead poisoning . For instance, several German states have required use of non-lead rifle ammunition when hunting in state forests, and are examining the implementation of this transition . Details on the regional provisions on the use of lead rifle bullets the European member states are given in .
EU conventions and agreements
In its 7th Environmental Action Program , the EU calls for strategies to achieve a non‐toxic environment and proposes that “by 2020, chemicals are produced and used in ways that lead to the minimisation of significant adverse effects on human health and the environment”. Allowing hunters to use lead—a well-known SVHC—in hunting ammunition results in direct environmental emissions above 18 000 tons per year in Europe, which is clearly incompatible and inconsistent with the EC’s stated goal of minimizing the use of hazardous chemicals.
Many provisions and agreements of other European directives, conventions and action plans are relevant to lead ammunition and sustainable hunting practice, and make statements regarding the wise or prohibited use and phase out of lead ammunition. These include the ‘Bern Convention’  and the Birds  and Habitats Directives  (details are given in ). The Action Plan of the of the African-Eurasian Migratory Waterbird Agreement (AEWA, ) requires that “parties shall 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’’ (Annex 3, Action Plan point 4.1.4). The agreed final phase out date was 2017 .
Also, the Conference of the parties to the Convention on Migratory Species  resolved in November 2014 that all contracting parties, including the European Union, must replace lead ammunition (lead shot and bullets) used for hunting in all habitats with non-toxic substitutes, in order to reduce significant poisoning of migratory birds . So far, no European party complies with the provisions of AEWA and CMS to replace all lead ammunition, even though these are politically binding for contracting countries.
Risk management options for regulating lead shot under REACH
Recently, Sweden proposed to identify metallic lead as SVHC based on its classification as being toxic for reproduction. After the adoption of this proposal, metallic lead was candidate listed in June 2018. This means that risk information for lead content above 0.1% in articles, including lead shot and lead-containing bullets, must be provided to professional users and be made available on request to consumers (Article 33 in REACH). “Article” is the REACH term for products with a special shape, surface or design, which determines its function to a greater degree than does its chemical composition. REACH would impose significantly different duties and obligations if hunting ammunition were classified as an article and not as a mixture. Specifically, the duty to communicate information (e.g., to respond to consumers request whether a product contains a SVHC) only applies to products defined as articles and not to mixtures. Discussions 2014 among stakeholders, member states’ experts and the EC revealed that there is no EU-wide consensus as to whether lead in cartridges and as the core of bullets is to be regarded as an article or as a mixture. The EC finally specified that ammunition should rather be considered as articles . ECHA supported this view, stating that “ammunition cartridges that are designed to launch a bullet are considered to be articles with an integral substance/mixture (the propellant) because the shape, surface and design of such ammunition cartridges determine their function to a greater degree than do their chemical composition” . For all lead ammunition regarded as articles the SVHC status would theoretically place pressure on manufacturers and distributers to communicate the hazard information to users further downstream. Practically, however, these obligations of better risk communication (which include also providing information to hunters upon request) may remain ineffective as long as the global scientific consensus on the risks from lead is denied by certain hunting and ammunition organizations [31, 37, 38].
If metallic lead were prioritized for inclusion in Annex XIV, all uses of the substance above the concentration limit of 0.1% would require authorisation. This means, that by definition an authorisation would cover all manufacturing and use of lead ammunition, not only the use resulting in the identified risk, i.e., the use of lead ammunition in hunting. However, the authorisation does not cover imported articles. Thus, lead in hunting ammunition would still be accessible for purchase within the EU and this option may in isolation possibly result in increased import of lead ammunition. A combined restriction on imported lead would solve this problem, but would need additional efforts and time. Based on these considerations, authorisation of lead appears practical but less effective than a restriction.
So far, no harmonized environmental classification (CLP) has been established for lead in its metallic form. Therefore, Denmark proposed in 2017 to classify metallic lead as an aquatic toxic compound (acute 1 and chronic toxic 1). This suggestion for classification is currently in the process of being adopted. However, as the substances are already classified as toxic to reproduction in Category 1A, the additional classification of aquatic toxicity will neither decrease exposure from lead—either from articles or from indirect sources of exposure—nor trigger further risk management measures. As discussed above, it is unlikely that any additional classification or improved risk communication along the supply chain will significantly discourage hunters from buying lead ammunition if lead-based ammunition is still purchasable.
During the past decades it has become obvious that voluntary or partial restrictions on the use of lead ammunition have been largely ineffective, and that national and international legislation is required in order to ensure effective compliance and to create a market for non-toxic ammunition . Though the ecological risks from lead ammunition are well described, there is little evidence that hunters or other stakeholders have made substantial voluntarily progress towards transitioning to lead-free substitutions. Furthermore, a voluntary approach appears unfeasible because it does not provide the legal assurance that manufacturers require to produce, distribute and market new lines of non-lead ammunition .
A restriction could include the manufacturing, certain uses and/or the placing on the market. A mayor part of lead shot is produced and imported from outside the EU and traded between Member States. Consequently, a restriction covering also imports of lead ammunition for hunting appears to be most effective to implement and faster than authorisation.
REACH restriction of lead shot in wetlands
Due to the well-grounded environmental and human health concerns about exposure to lead shot used for hunting, and in the interest of complying with the aforementioned AEWA and CMS agreements, the EC requested in 2015 that ECHA prepare an Annex XV restriction proposal on lead in shot used in wetlands. Taking into account other legal acts already in place, ECHA concluded that an EU-wide restriction would be the most appropriate measure . However, the restriction covered only “the use of lead and its compounds in shot (containing lead in concentrations greater than 1% by weight) for shooting with a shot gun within a wetland or where spent gunshot would land within a wetland, including at shooting ranges or shooting grounds in wetlands” .
During the restriction process, several stakeholders asked why the restriction is limited to wetlands. The EC argued that (1) the scientific knowledge on lethal and sub-lethal effects of lead is most well-established with regard to waterbirds, (2) waterbirds are expected to feed mainly in wetlands, and (3) harmonization of the conditions of use of lead in shot in wetlands is a priority at EU level since national legislation has already been enacted by some Member States or regions to implement the AEWA .
In June 2018, ECHA’s scientific committees (RAC and SEAC) adopted ECHA’s proposal that lead gunshot requires restriction in wetlands [41, 42]. Before adoption into law, the restriction needs to be agreed on by the EU REACH Committee representing Member States presumably in April 2020. The restriction will come into operation 36 months after the final adoption by the EC.
Evaluation of the proposed restriction of lead shot in wetlands compared to a full restriction including non-wetlands
Majority of lead shot emitted to non-wetlands The proposed restriction will minimize the discharge of lead gunshot into wetland environments, which is currently estimated to be 357 t per year. The emission of lead shot in non-wetlands not covered by the current restriction is approximately 14,000 t per year (40 times higher than that in wetlands) (Fig. 3). Thus, the proposed restriction will only reduce a minor part of total lead shot emissions into the environment.
Species feeding in terrestrial areas need protection Many birds, including many non-waterbirds, ingest grit. Shot can be mistaken by birds for stones or grit in areas where hunting takes place [43, 44] (Table 3). In Europe, many bird species feed in both agricultural and terrestrial landscapes, especially outside of the breeding season . The loss of aquatic habitats in recent time likely exacerbated by global warming, will further reduce the availability of wetland habitats for wintering  and for foraging, for many bird species. In most remaining high-quality wetlands, strong competition for food will in turn force birds to forage outside the main wetland . More recent research (reviewed by [8, 13, 15]) revealed that the ingestion of lead shot by different wildlife taxa feeding in dryland is widespread and results in annual deaths of 1–2 million waterbirds. Therefore, more targeted action is necessary to address harms from the use of lead shot, including in terrestrial habitats.
Enforceability and practicality
With a partial restriction in wetlands, lead shot will still be distributed throughout the EU and will remain easy to purchase. Field inspections by national authorities to enforce compliance with the restriction appear rather impractical and expensive. A complete restriction of lead gunshot in the entire EU territory (prohibiting the placing on the market and use of any lead gunshot) would be more practical, because it would allow REACH authorities to enforce compliance at the point of sale, e.g., retailers, and not in the field . SEAC  concluded that for hunters, a total ban would be easier to comply with compared to the current proposal, because they will not have to identify the wetland area covered by the restriction. Denmark and the Netherlands have shown that total bans can be successfully implemented and enforced .
Finally, considering a total restriction on the use of lead shot in all areas, not only wetlands, or a full ban of lead in all hunting ammunition including rifle bullets would have saved time and efforts since now a follow-up restriction process needs to be initiated.
Costs and benefits The socio-economic analysis under REACH serves as a voluntary “decision-support tool to evaluate the costs and benefits an action will create for society”, i.e., the social costs, by comparing what will happen if this action is implemented as compared to the situation where the action is not implemented [46,47,48]. Within the socio-economic analysis a distinction is made between costs to the private sector (e.g., hunters) and to the society and the environment as a whole. The social cost in Europe of the restriction of lead shot in wetlands is in the order of 30–60 million euros per year, which attribute mainly to EU hunters (including costs for mandatory testing, technical adjustments to shotguns, replacement of shotguns, and the overall cost of more expensive alternative ammunition) . Currently, between 4,00,000 and 1500,000 waterbirds of 33 species are estimated to die every year from ingesting lead shot in EU wetlands . The total social benefits of the proposed restriction, in relation to preventing these deaths, are estimated to be greater than 100 million euros per year . Most recently, Andreotti et al.  estimated that the annual cost of releasing captive-bred birds in order to replace the estimated 700,000 wild waterbirds killed by lead poisoning in the EU would be around 105 million euros. These figures establish the proportionality of the suggested restriction as applied only to wetlands.
For terrestrial habitats, only preliminary estimates of costs and benefits exist. 1–2 million birds die annually due to lead poisoning in EU territory [8, 49]. Extrapolating the costs and benefits of a lead restriction from wetlands to non-wetlands, based on the number of birds killed, yields a preliminary estimate of 200 million euros in savings per year. Finally, the enforcement costs would be lower for a total ban than for a partial restriction, because enforcement would be targeted at retailers (which are stationary) rather than at hunters while hunting . The overall benefits from a total restriction are expected to considerably outweigh the costs, and it may therefore be more effective than the proposed partial restriction covering only wetlands.
Availability and suitability of non-lead substitutes The most common non-lead shot type is currently made of steel, although bismuth, tungsten, nickel and copper are also used . It should be noted, that also non-lead substitutes might be toxic to a certain degree when ingested by wildlife or humans. For instance, nickel in lead shot should be avoided as an incidental component because of potential carcinogenicity concerns about such embedded shot in birds and other animals . Bismuth shot contains traces of lead that is shown to be deposited with bismuth in the target animal . Generally, substitutes for lead products must be non-toxic to all wildlife, which assumes that criteria exist for the evaluation of their toxicity . However, the chemical composition of non-lead gunshot used for hunting waterfowl is regulated only in Canada and the USA. Compositional basic criteria for non-toxicity for alternative gunshot have recently been proposed by Thomas  and are based on established experimental toxicity protocol by the U.S. Fish and Wildlife Service . Applying these criteria would support the transition to non-lead alternatives since they would facilitate the production and international trade in non-lead products, and promote easier enforcement and user compliance with non-lead standards .
Alternatives to lead shot cartridges are available to purchasers in most European countries (22 of 29), and these can be used as effectively as lead shot [53,54,55]. Many studies have demonstrated that steel and other alternatives are as effective as lead ammunition; shooting efficacy and the success of the shot are related to the shooter rather than the ammunition, though shooters may need to adapt to using different ammunition . Reports of positive experiences with the use of non-lead ammunition are increasingly available from countries that have enforced regulations for three decades, including North American countries, the Netherlands, Spain and France .
Adaption costs The adaptation cost for an individual hunter of using lead shot alternatives for hunting in wetlands is relatively low (estimated at 50–60 euros per year) compared to the overall budget (estimated to be approximately 3000 euros per year) spent on hunting . The cost of alternatives to lead shotgun ammunition in terrestrial areas would likely be comparable to the cost of using alternatives in wetland hunting. In general, legislation and prices are the driving forces behind public consumption and availability of goods. Thus, a total restriction of lead shot (and lead bullets) would likely result in greater market demand for non-toxic alternatives, and would encourage enhanced technical development, production, and availability of these alternatives .
Acceptance Usually, hunters are well-organized at national and international levels, and are represented effectively by industry and politically influential groups, including heads of state and royalty . The polarization and resistance of certain stakeholder groups [31, 37, 38] may be one reason why no union-wide solution has been reached so far, in contrast to restriction of other substances with similar socio-economic importance. However, at least Denmark  demonstrated that within a few years of the implementation of the first regulations, hunters and their organizations changed their attitude towards the regulation, with many of them becoming positive and constructive. Since the complete ban of the use, trade and possession of lead shot in Denmark in 1996, there is now full compliance: not a single lead shot was detected in 690 mallards that were examined (Anas platyrhynchos) . Similarly, Valverde et al.  recently demonstrated that in Spain, the ban of lead ammunition in wetlands since 2001 has been effective and successful, based on decreasing lead body burden in birds. Assuming a similar change of mind in Europe, the acceptance of a future Europe-wide restriction of lead shot and lead bullets in all habitats appears achievable. This assumption is substantiated by the supportive comments provided by organizations representing hunters and ammunition lobbyists during the public consultation on the restriction .
Proposal for solution
The proposed restriction on lead gunshot in and over wetlands, beyond any measures already in place, is a good first step to trigger further action towards the reduction of lead emissions in wetlands and the protection of birds from the acute and sub-lethal effects of lead exposure via ingestion. There is, however, a large body of evidence showing that many different wildlife species can be poisoned by lead ammunition when feeding outside wetlands. In accordance with SEAC and ECHA [6, 42] we argue that the most effective, economic, practical and enforceable measure to limit the identified risks and protect these species completely, would be to enforce a prompt total restriction under REACH on the use of lead shot. To prevent that lead gunshot remains available, since placing on the market and use for non-hunting shooting would be exempted, a restriction of all uses of lead shot, and the placing on the market, would be most efficient. Even though the mandate from the EC addressed the use of lead shot in wetlands only, and a total ban was not further assessed by ECHA, this measure should now be considered during the follow-up restriction activities on lead shot in terrestrial areas. It should be noted, however, that the economic costs and benefits of a total restriction have not been evaluated in detail in the present study but will be assessed during the ongoing restriction activities. Until the total restriction enters into force, Member States could consider making use of paragraph 5 of the restriction of shot in wetlands, that they “may on grounds of human health protection and environmental protection, impose more stringent measures than those set out in paragraphs 1 and 2 [use and possession of lead shot]”.
Outlook—risk management of lead in rifle bullets
Bullets are used for hunting large game such as deer, wild boar and other mammals. Some calibers are also used for smaller game and pest control. In general, the use of lead-based rifle bullets raises well-described concerns similar to those arising from the use of lead shot. The principal concern with lead bullets is that the lead core can disintegrate upon entering the animal and spread fragments into adjacent organs and tissues [15, 59]. Small fragments of the lead core and sometimes of the jacket can be left behind, producing a large cloud of lead particles around the wound channel [59, 60]. Thus, contrary to common belief, the lead dispersed throughout the flesh can only be partly removed by cutting away and discarding tissue from around the wound channel (Krone, personal communication). Higher lead levels and massive dispersion of bullet fragments were recently detected in the flesh of wild boar (Sus scrofa) and roe deer (Capreolus capreolus) shot with lead bullets, as compared to individuals shot with lead-free ammunition [61, 62]. As lead is considered a non-threshold toxicant, the consumption of contaminated game meat results in risks to humans. Most notably, it poses a risk of harm to neurodevelopment in children and may lead to reduced intelligence quotients in exposed groups.
In addition, many wildlife species are vulnerable to lead exposure from rifle shooting due to the traditional hunters’ practice of removing the entrails of quarry killed in the field and either leaving this on the ground or burying it. The poisoning of scavengers occurs from the ingestion of lead bullet fragments in these discarded gut piles, and in fatally shot-and-lost animals [15, 59]. As a consequence, in Germany lead poisoning from lead in rifle ammunition is the most common cause of death in white-tailed sea eagles (> 20% of animals found dead), which significantly impairs population growth . Due to the widespread use of lead bullets in the EU, similar threats to population levels likely exist for other species but have not yet been analyzed systematically.
Availability and suitability of substitutes
Non-lead rife bullets are broadly available throughout Europe [53, 64]. Most of the non-lead bullets developed to replace lead are made from pure copper or copper-zinc alloy, with or without other metal jacket coatings [71, 72]. They can be divided in monolithic copper- or copper alloy types, occasionally with nickel coating or aluminum or plastic tip and such with jacket–core construction, e.g., a tin core replacing lead [65,66,67]. These new developments allow hunters comparable performance and accuracy compared to traditional lead-based ammunition in most calibers [53, 64, 68,69,70,71]. Lead-free hunting rifle bullets are equal to conventional hunting bullets in terms of killing effectiveness for the target animals (usually roe deer, wild boar and red deer) and thus meet the welfare requirements of killing wildlife without superfluous pain . The recent study by Martin et al.  clearly demonstrated that the escape distance of an animal as an indicator for bullet effectiveness depends more on shot placement, shooting distance, hunting method or the age of the hunter than on the material . Similarly, Stokke et al. demonstrated that the relative killing efficiency of lead and copper bullets is similar in terms of animal flight distance after fatal shots .
No health risk due to the presence of copper, the principal component of non-lead bullets, and zinc in game meat at typical levels of consumer exposure was found for both types of ammunition . Therefore, it is unlikely that these elements pose health risks to wildlife as it these do also not accumulate in waterbirds . Paulsen et al. showed that most of the available rifle bullet types contain also lead in low concentration (< 0.02% of the bullet mass) and that bullets with nickel plating may release nickel during simulated digestion [66, 67]. Consequently, levels of aluminum, nickel, and lead should be kept as low as possible during bullets’ manufacture to avoid hazardous impact . As with lead shot, no national or international regulation exists for the composition of non-lead rifle ammunition [50, 51]. Only California regulations stipulate that non-lead bullets must contain less than 1% lead by mass . As long as no limits for hazardous substances in non-lead ammunition are determined and as proposed for non-lead gunshot above, these criteria could be used for regulating the composition of rifle ammunition in Europe.
An analysis for the European market concluded that product availability of non-lead rifle ammunition in a wide range of calibers is high in Europe and is suited for all European hunting situations  at least 13 major European companies make non-lead bullets for traditional, rare, and novel rifle calibers. It has often been suggested by hunters that the switch to non-toxic alternatives causes extra costs. However, a comparison of retail prices for lead-core and non-lead rifle ammunition of nine commonly used calibers (from .223 to .416) in different weights, types, and brands available across the USA found that prices were generally similar [53, 73]. Similarly, any increase in annual costs for a hunter due to alternative non-lead bullets is likely to be marginal when compared to their overall hunting budget and would not considerably affect individual hunters . It is important to consider that generally, the availability of lead substitutes is a direct consequence of regulation, because only legislation creates the required assurance that non-lead products will be made, distributed and used at the national level .
Copper bullets of caliber < 6 mm may not stabilize when fired from the same rifle barrel, which relates to the function of the twist rate of the barrel’s rifling [56, 74]. A transition to the lead-free use of rifle bullets, particularly small calibers, may take longer since hunters will need to change gun barrels to a more appropriate twist rate, or to await the development of denser lead-free bullets . Therefore, a realistic phasing-out period should be determined allowing all actors to comply, by reflecting inter alia the composition and suitability of available alternative ammunition types and the time needed by hunters to change gun barrels and train shooting.
Proposal for risk management of lead bullets
Consistent with the approach of regulating lead in shot, the most practical solution would be that ECHA (as currently done) thoroughly assesses the need for and the implications of a total restriction of lead bullets considering the socio-economic aspects and the effectiveness for human and environmental risk reduction. As with lead shot, a total restriction on the use and placing on the market of lead bullets appears to be the most appropriate management tool. A key factor determining acceptance of any restriction would be the timing and extent of the phase-out period for lead bullets, which should reflect the availability and suitability of substitute ammunition and the creation and application of education-awareness programs, ideally in close collaboration with hunter organizations .