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REACH restrictions underway for lead and tattoo inks – where are we?
REACH restriction is a regulatory tool that is used when the risks from a substance are not controlled by other regulatory means and need to be addressed Union-wide. It means that the manufacture, placing on the market or use of a substance is limited or banned. We share with you the latest developments with the most topical restriction proposals.
Overview: lead and its compounds
Lead is highly regulated in the EU and worldwide. Restrictions or total bans for a range of uses in several sectors apply in the EU. For example, lead carbonates and lead sulphates have been restricted in paints for more than twenty years. The hazards of lead are well known both to human health and the environment. It affects the blood, the nervous, immune, renal and cardiovascular systems as well as accumulates in soils and sediments. It is also toxic to plants, animals and micro-organisms.
The list of substances restricted under REACH (Annex XVII) already contains an entry for lead and its compounds. This entry covers the uses of lead and its compounds in jewellery and in some consumer goods, with parts that children can put in their mouths. The latter restriction applies from 1 June 2016. The costs and benefits of these two restrictions are shown in Table 1.
Table 1. Monetised benefits of two lead restrictions. Lead negatively affects the central nervous system and causes, for example, a loss of IQ when jewellery is put in the mouth. Source: Cost and benefit assessments in the REACH restriction dossiers
Lead and its various compounds also have harmonised classifications in the Classification, Labelling and Packaging (CLP) Regulation for their human health and environmental effects.
Different lead compounds have also been scrutinised under the SVHC Roadmap, where the best options for controlling the risks for substances are analysed through the risk management option analysis (RMOA). As a result, many lead compounds are already on the Candidate List of substances of very high concern (SVHCs).
Some, for example lead chromate, have already ended up on the Authorisation List and now need permission before they can be used. In addition, the European Commission has requested ECHA to prepare new restriction proposals for lead in shot and lead used as stabilisers in polyvinylchloride (PVC).
Lead in shot over wetlands
Lead in gun shot may pose a risk to human health and the environment, in particular to aquatic bird species. Several reports link the eating of spent shot with the deaths of ducks and all species of birds. Reports are also warning about possible risks to people who eat game meat, such as pheasants. Many EU Member States already have national legislation in place to restrict the use of lead in shot. In addition, there is an International Agreement on the Conservation of African-Eurasian Migratory Waterbirds (AEWA) under the auspices of the UN Environment Programme, to which the EU is a party.
To manage the risks, harmonise the conditions of use throughout the EU and adhere to the international agreement, the European Commission requested ECHA to assess the risk and the need for phasing out lead shot in wetlands.
The intention to prepare a restriction dossier was announced in April 2016. There is also a call for evidence to gather more information on the issue. In the coming months, ECHA will organise a workshop to inform its stakeholders of the restriction initiative and to gather further information on lead in shot.
Furthermore, the Agency is now collecting information for the assessment of the risk and the socio-economic impact for other uses of lead in ammunition. These include hunting in terrains other than wetlands, target shooting as well as using lead weights for fishing. In its assessment, ECHA will pay special attention to aspects related to animal welfare in hunting and preventing accidents to hunters and sport shooters. If the risk is demonstrated, this might lead to the preparation of a separate dossier for restriction.
Did you know?
Lead in PVC
Lead is used as a stabiliser in polyvinylchloride (PVC) plastics and is released when articles produced from PVC are used. The Commission has asked ECHA to assess the potential risk of lead in PVC plastics.
ECHA will consider issues like the concentration limits of lead in recycled PVC, the availability of analytical methods and the potential impact on humans exposed through the environment (including workers). The intention to restrict lead in PVC has already been published in the registry of intentions. ECHA has already carried out a call for evidence to gather further information. The Annex XV restriction dossier is foreseen for submission in October 2016. The eventual restriction will complement a voluntary EU agreement to stop using lead stabilisers from 2015.
Many reports show significant concerns for public health stemming from the composition of inks used for tattooing. The most severe concerns are allergies caused by the substances in the inks and possible carcinogenic, mutagenic or reproductively (CMR) toxic effects.
As tattoo inks are currently not subject to harmonised control in the EU, ECHA has been asked to assess the risks, the relevant socio-economic impacts and the need for Union-wide action by preparing a dossier for restriction. The potential restriction would not control risks from poor hygiene that may also be an issue with tattooing. The intention for a restriction dossier is likely to be published in July 2016 and is likely to be developed in cooperation with several Member States.
Other ongoing restriction work
Formaldehyde and formaldehyde releasers
The European Commission has requested ECHA to investigate formaldehyde releasers and their uses. The aim is to help the Commission consider whether there are grounds to request ECHA to prepare a restriction proposal on formaldehyde. Another aim is also to support the Member States (France and the Netherlands) in analysing formaldehyde under substance evaluation and the SVHC Roadmap.
Polycyclic aromatic hydrocarbons (PAHs) and other substances in synthetic sports pitches
The European Commission and the Member States clarified in March 2016 that the rubber crumb used as infill material on synthetic turf sports pitches does not fall within the scope of an existing restriction of PAH substances. Being a mixture, rubber crumb needs to fulfil the conditions under the restriction on CMRs.
The Commission is now expected to ask ECHA to assess the remaining risks posed to human health by synthetic turf to determine whether a further restriction is needed.
Guideline for lead in consumer articles
To help manufacturers, importers, distributors and users of articles as well as Member State competent authorities, ECHA has prepared a guideline on the restriction for lead and its compounds in articles. The restriction will apply as of 1 June 2016.
The guide focuses on giving descriptions and examples of article types, which fall within or beyond the scope of the restriction. The document is endorsed by the Member States and will be published shortly.
- Restriction under REACH
- Current restriction intentions
- List of substances restricted under REACH
- Lead info card
- Terminology - in 23 languages
Text by Nedyu Yasenov
Top image: Fotolia
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What to know about...REACH authorisation, Newsletter 4/2015
Explaining REACH: Restricting substances – how is it done? Newsletter 3/2013
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)