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. A Member State, 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 Member States, 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 listed below:
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 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 Member States 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.
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 Member State 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 steps must be taken:
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 Member State 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 from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006
Restrictions concerning nickel are set out in entry 27 of Annex XVII to REACH. In order 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 two ECHA Committees confirmed an inadequately controlled risk to human health from the exposure to the four phthalates DEHP, BBP, DBP and DIBP in articles. The restriction proposal took into account the cumulative effects and combined exposure to these four 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 Member States 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 Member State in which the relevant electrolysis installation is located, as well as on monitoring results for chrysotile in air, is so required by the Member State in order 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 Member States had to communicate the national measures to the Commission by June 2011. The information communicated by EU Member States 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 Member States to grant derogation for professional use under certain conditions. The following Member States have made use of this possibility:
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.