Restrictions are regulatory measures to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance. A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration. Restrictions setting out conditions for the placing on the market of substances apply to both domestic production and imports.
Articles 69 – 73 of REACH set out the procedure for adopting restrictions. An EU country, or the European Chemicals Agency (ECHA) on request of the European Commission, can propose restrictions if they find that there are unacceptable risks that need to be addressed on a Union-wide basis. ECHA can also propose a restriction for articles containing substances that are in the authorisation list (Annex XIV).
Restriction proposals are subject to public consultations, which are organised by ECHA. Anyone can comment on a proposal to restrict a substance. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities. Comments from the EU or beyond are welcomed.
The ECHA Committees for risk assessment (RAC) and socio-economic analysis (SEAC) provide opinions on restriction proposals, taking into account the comments received from the public consultations. These opinions are transmitted to the European Commission, who together with the EU countries, take the final decision. Restrictions are enacted via amendments of Annex XVII to REACH.
If the Commission finds that the conditions for amending Annex XVII are not fulfilled at the end of the process, the closure of the restriction procedure is formally announced in the form of a Commission Communication.
These cases are as follows
Contact allergy has long been recognised as a frequent and potentially disabling problem for consumers and workers. In August 2015, Sweden proposed the skin sensitiser HDDA (hexane-1,6-diol diacrylate) for identification as substance of very high concern (SVHC) according to Article 57(f) of REACH. The substance was finally not identified as a SVHC as an equivalent level of concern could not be demonstrated. In a follow-up discussion, REACH competent authorities agreed on the need to explore regulatory options to better protect workers and consumers from skin sensitisers.
On 5 December 2017, the Commission organised a workshop on regulatory options for skin sensitisers.
Article 68(2) of REACH provides a simplified procedure which the Commission may use in relation to substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), categories 1A and 1B on their own, in mixtures or in articles that could be used by consumers. The procedure differs from the standard restriction procedure of Articles 69 to 73, which requires the preparation of an Annex XV dossier to initiate the restriction process, public consultation, opinions by RAC and SEAC and the consultation of the forum.
The Commission adopted a restriction (Dec 2013) following the procedure of Art. 68(2) for polycyclic aromatic hydrocarbons (PAHs) in rubber and plastic.
Building on that experience, the Commission developed a structured approach to the implementation of Art. 68(2) for articles, which was presented in a paper (421 kb) (Nov 2014) and discussed with the EU countries' competent authorities and the stakeholders.
Implementing the approach developed in 2014, the Commission started to work on a potential restriction of CMRs 1A and 1B in textiles. This included a public consultation and a technical workshop organised on 8 February 2017.
The restriction of 33 CMRs in clothing, textiles and footwear is set out in entry 72 of Annex XVII to REACH by Regulation (EU) 2018/1513, applicable from 1 November 2020.
The restricted substances may be present in these articles either from the production process or because they have been added intentionally to give specific properties such as to prevent shrinkage or make fabric crease-resistant. Consumers can be exposed to these hazardous substances through skin contact, inhalation or unintentional ingestion of dust released from the textile fibres. Small children are also at risk due to a possible oral exposure.
An explanatory guide on the restriction was endorsed by the competent authorities for REACH and CLP (CARACAL) on 27 June 2018 [CA/44/2018]. It aims to clarify the scope of the articles intended to be covered by the restriction and provides a list of available analytical methods in certain matrixes that can be used for the determination of the different substances.
REACH contains a safeguard clause (Article 129) which enables an EU country to take provisional measures (e.g. a restriction) where it has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a mixture or in an article, even if satisfying the requirements of REACH. The following necessary steps to take are
The safeguard clause has been applied twice so far
Title VIII and Annex XVII of REACH replaced the earlier legislation setting out restrictions on chemicals, i.e. Directive 76/769/EEC as of 1 June 2009. In the frame of the provisions on transitional measures from the pre-REACH restriction regime, which are set out in Article 137 of REACH, 2 measures were adopted.
The first prohibits the placing on the market of acrylamide for grouting applications (Regulation (EU) No 366/2011). The second prohibits cadmium in jewellery, brazing fillers, and plastics (Regulation (EU) No 494/2011 with related Corrigendum OJ L 136/105).
Article 67(3) of REACH provides that until 1 June 2013, an EU country may maintain any existing and more stringent restrictions in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified according to the treaty. The Commission had to compile and publish an inventory of these restrictions by 1 June 2009. Read the Communication on Article 67(3) of Regulation (EC) No 1907/2006
Chemicals in tattoo ink are of concern for public health causing allergies and possible long-term adverse effects such as cancer. This restriction aims to achieve a harmonised high level of protection of human health and free movement of goods within the EU and to ensure that EU citizens are equally protected independently of the country where they get the tattoo and whether the ink is manufactured in the EU or not.
This REACH restriction covers all substances banned by the EU Cosmetic Products Regulation, substances with harmonised classification as CMRs or as skin sensitiser, skin irritant or corrosive, eye damaging and irritant substances, as well as a list of impurities, aromatic amines and colorants. The restriction includes practical concentration limits established either for groups of substances or for individual substances such as certain azodyes and carcinogenic aromatic amines, polycyclic aromatic hydrocarbons (PAHs), metals and methanol as well as harmonised labelling requirements to give consumers and tattooists additional information, to facilitate implementation of the restriction, to prevent fragmentation of the internal market and to ensure that investigations can be properly carried out in the event of adverse health effects.
There is a general transitional period of 12 months before the entry into application of the restriction. 12 additional months are granted for the entry into application of the ban for Pigment Blue 15:3 and Pigment Green 7, for which industry highlighted the need of more time to find safer and technically adequate alternatives whilst ensuring the availability of the inks on the market in the meantime.
The restriction was prepared by the European Chemicals Agency (ECHA) together with the Norwegian Environment Agency, the Italian Istituto Superiore della Sanità, and the Danish Environmental Protection Agency and with the contribution of the German Federal Institute for Risk Assessment (BfR) and Federal Institute for Occupational Health and Safety (BAuA) following a request from the European Commission in 2015.
Restrictions concerning nickel are set out in entry 27 of Annex XVII to REACH. To monitor compliance with the restriction, specific analytical standards have been developed
A restriction proposal of four phthalates DEHP, BBP, DBP and DIBP in articles was prepared in 2016 by the European Chemicals Agency (ECHA) and Denmark. The assessment of the proposal by the 2 ECHA Committees confirmed an inadequately controlled risk to human health from the exposure to the 4 phthalates DEHP, BBP, DBP and DIBP in articles. The restriction proposal took into account the cumulative effects and combined exposure to these 4 phthalates from different articles.
The restriction of the placing on the market of articles containing the four phthalates in a concentration equal to or above 0.1% by weight individually or in any combination in any plasticised material is set in a revised entry 51 of Annex XVII to the REACH Regulation.
Previous restrictions concerning certain phthalates are set out in entries 51 and 52 of Annex XVII to REACH, both of which contained an obligation to review the restrictions initially adopted
The use of asbestos fibres and articles containing the fibres is prohibited by entry 6 in Annex XVII to the REACH Regulation. Specifically, 6 types of asbestos are listed: chrysotile, crocidolite, amosite, anthophyllite, tremolite, and actinolite.
This last amendment set 1 July 2025 as the final date for the possibility for EU countries to maintain exemptions granted for the use of diaphragms containing chrysotile in electrolysis installations which were in use on 13 July 2016. The derogation applies to the use of such diaphragms in those specific installations as well as to chrysotile used exclusively for their maintenance, subject to the conditions of a permit set in accordance with Directive 2010/75/EU (the Industrial Emissions Directive).
Downstream users of chrysotile benefiting from the exemption have to report yearly on the amount of chrysotile used in diaphragms to the EU country in which the relevant electrolysis installation is located, as well as on monitoring results for chrysotile in air, is so required by the EU country to protect the health and safety of workers.
EU Member States may also allow the placing on the market of articles in their entirety containing asbestos fibres, which were already installed and/or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health.
When using this possibility, EU countries had to communicate the national measures to the Commission by June 2011. The information communicated by EU countries to the Commission is contained in the report below.
In 2014/2015, ECHA assessed whether the use of grill lighter fluids and fuels for decorative lamps labelled R65 or H304, intended to be supplied to the general public should be restricted and presented the outcome in the form of an Annex XV restriction dossier (927 kB). ECHA concluded that in the light of the available evidence, no further action in addition to the existing restriction was required.
The restriction on dichloromethane in paint strippers contained in entry 59 of Annex XVII to REACH allows EU countries to grant derogation for professional use under certain conditions. Before its withdrawal from the Union, the UK was the only EU country who made use of this possibility.
The restriction on lead in gunshot in or around wetlands contained in entry 63, paragraphs 11 to 14, will apply after 15 February 2023. It allows EU countries to maintain stricter national legislation already in force on 15 February 2021. When using this possibility, EU countries must communicate texts of such stricter national legislation to the Commission. See the texts received by the Commission.
The ECHA forum has developed a document listing analytical methods that it recommends as valid to check compliance with restriction listed in Annex XVII of REACH. This document intends to be a living document and will be periodically reviewed.