Compliance with REACH restriction and authorisation measures (Signal)

Key messages: 82% of the products inspected complied with the restrictions set under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation based on targeted enforcement projects. The presence of phthalates in toys and cadmium in brazing fillers were the two REACH restriction entries with the highest rates of non-compliance. The non-compliance rate is higher in products which originates from outside the European Economic Area (EEA) or whose origin is not known.  High level of non-compliance (up to 40%) with authorisation requirements has been identified in another targeted enforcement project.

Non-compliance rate (%) and number of products checked per restriction entry in Annex XVII of the REACH Regulation

Restriction entry in Annex XVII of REACH	Non-compliance rate (%)	Number of products checked
Phthalates in toys - diethylhexyl phthalate (DEHP), Dibutyl phthalate (DBP) and Benzyl Butyl Phthalate (BBP) (entry 51) - Di-isononyl phthalate (DINP), Di-isodecyl phthalate (DIDP) and Di-n octyl phthalate (DNOP) (entry 52)	19.7 10.4	1,202 (toys and childcare articles)
Cadmium in brazing fillers (entry 23)	14.1	86 mixtures
Asbestos fibres (entry 6)	13.6	213 articles
Chromium VI in leather articles (entry 47)	13.3	467 articles
Nickel in metal parts of clothes (entry 27)	11.1	27 articles
Polycyclic aromatic hydrocarbon (entry 50)	7.9	382 articles
Heavy metal in jewellery - cadmium (entry 23) - nickel (entry 27) - lead (entry 63)	12.1 7.9 6.7	1,134 articles 888 articles 1,173 articles

When the EU establishes regulatory risk management measures, the next step is to ensure that duty holders (those who must follow the rules) implement those measures. Enforcement is the process by which national authorities check whether duty holders comply with regulations such as the REACH, Regulation, the Classification, Labelling and Packaging (CLP) Regulation and the Biocidal Products Regulation.

Under the REACH Regulation, duty holders are either importers, manufacturers, downstream users or distributors of chemical substances. Enforcement is the responsibility of national authorities. Consequently, there is some variation in the way checks are carried out by different national authorities. Coordinated and harmonised enforcement is key to the success of the regulations and is provided for by the Forum for Exchange of Information on Enforcement (Forum).

On top of regular enforcement done by national authorities, some coordinated projects are initiated at EU level by the Forum. The Forum’s Reach-en-Force (REF) projects are one-time enforcement initiatives carried out by inspectors from the participating EU Member States and European Economic Area (EEA) countries. Three REF projects are looked at:

REF-4 on harmonised enforcement project on restrictions;
REF-10 on compliance with several chemical regulations (including restrictions);
REF-9 on enforcement of compliance with REACH authorisation obligations.

Harmonised enforcement projects on REACH restrictions

The REF-4 project aimed to raise awareness of the restrictions under Annex XVII of the REACH Regulation; to identify non-compliance related to restrictions in the EU; to follow-up with enforcement actions; and to achieve a greater degree of compliance, and thus a greater degree of health and environmental protection.

The restrictions are provided in Annex XVII of the REACH regulation because the substances pose a risk to health and/or the environment in the use that is restricted. Preventing this risk is the duty holders' task along all steps in the supply chain.

Some 82% of the products checked complied with the inspected REACH Regulation restrictions (22 restrictions out of 67 entries in REACH Regulation’s Annex XVII were checked during the project). The two entries with the highest rates of non-compliance were phthalates in toys and cadmium in brazing fillers.

There were also entries where all checked products were found to be compliant (for example, volatile esters of bromoacetic acid). An overview of the restriction entries where most non-compliances were found is provided in Table together with the number of products checks and non-compliance rates.

When tracking non-compliance based on a product’s origin, those originating from EU and EEA countries were non-compliant in 10% of cases. The highest non-compliance rate (39%) was observed for products whose origin could not be identified.

The results from this enforcement project show that there are significant amounts of non-compliant products — products containing restricted substances — on the EU/EEA market. As non-compliance relating to REACH Regulation restrictions cannot be determined by just looking at a product, the only way to increase compliance is to influence companies and enhance their responsibilities along the supply chain.

They need to get information on the chemical composition of products they buy from their suppliers. In tandem, measures must be implemented in the supply chain that will emphasise that it is not worth selling non-compliant products. In addition, enforcement authorities need to continue enforcing REACH Regulation restrictions by further analysing products on the market.

The REF-10 project identifies very similar concerns as the REF-4 project. This more recent project aimed at checking how different types of products placed on the EU market comply with chemical regulations. The project checked 2,047 products and assessed both articles and mixtures. The overall non-compliance rate was 18%. The non-compliance rate for articles was 20% and for mixtures 9%.

Within the articles category, the highest non-compliance rate was found for electrical products (52%) followed by toys (23%), fashion (15%) and sport articles (18%). The mixtures with the highest non-compliance rate were paint strippers (38%) containing dichloromethane, followed by glues (12%) containing toluene and chloroform.

Restricted substances within the articles category were predominantly found in metals and soft plastics. The restricted substances most often found in metal were lead in soldering points in electrical products and cadmium in jewellery. Phthalates and Short Chain Chlorinated Paraffins (SCCP) were most often found in soft plastics. Most non-compliances (49%) fell under the Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive followed by the REACH Regulation (13%), the Toy Safety Directive (10%) and the Persistent Organic Pollutants (POPs) Regulation (9%). In addition, as in the REF-4 project, the non-compliance rate was higher in products which originated from outside the European Economic Area (EEA) or whose origin was not known. 

The alerts reported by the EU’s Rapid Alert System for products posing a risk to human health and the environment (see the corresponding indicator Alerts for products posing a risk to human health and the environment) cover very similar restricted chemicals and types of products such as phthalates (in toys particularly) and lead.

Enforcement of compliance with REACH authorisation obligations

The REF-9 project aimed at checking compliance with REACH Regulation requirements on authorisation relating to the placing on the market and use of all substances from Annex XIV to the REACH regulation (the Authorisation List). These substances had sunset dates that had passed at the start of the project.

Of the 502 substances inspected by the project, 203 (40%) were found to be non-compliant with at least one of the REACH Regulation’s obligations checked in the scope of the project. REF-9 also found that of the 404 companies inspected, 162 (40%) were non-compliant. The substances from Annex XIV that were most frequently found in non-compliant cases were lead sulfochromate yellow (63% of cases were non-compliant), strontium chromate (51%) and chromium trioxide (35%).

The main non-compliant substances found in 203 inspections under REACH Regulation requirements were related to downstream user duties and are as follows:

26% of substance inspections were not in compliance with Article 56(2) (using the substance in accordance with the conditions of a granted authorisation to an actor upstream in the supply chain for that use);
26% of substance inspections were not in compliance with Article 37(5) (downstream user identifies, applies and, where suitable, recommends appropriate measures to adequately control identified risks); and
20% of substance inspections were not in compliance with Article 66(1) (notification of downstream users using the substance in accordance with Article 56 (2)).

In summary, the project found an overall non-compliance rate of 40% both for substance inspections and for companies, and a non-compliance rate of 26% for key authorisation duties. This is higher than the usual average of non-compliance for other provisions of EU chemicals legislation found by national inspectors from EU/EEA countries.

This difference can be partially explained by the complexity of the current situation. Placing authorised substances on the market and using authorised substances according to the conditions set by the authorisation decision are still new processes for duty holders. In many cases, these holders are small and medium-sized enterprises at the end of the supply chain. In general, the highest non-compliance rates observed by this project were for duties related to downstream users.

Forum for Exchange of Information on Enforcement (Forum): the Forum is a network of authorities responsible for the enforcement of a number of European regulations on chemicals (,,,,). It is a body of the European Chemicals Agency (ECHA) and aims to harmonise the enforcement of such regulations. Among other tasks, the Forum is mandated to identify best practices in enforcement, and develop enforcement strategies and tools for use by local inspectors.

The Forum also coordinates various enforcement projects. The main ones are Reach-en-Force (REF) projects, which are designed to harmonise enforcement in each Member State and check the current level of compliance of particular obligations imposed on industry by the REACH, CLP and Prior Informed Consent (PIC) regulations.

REF projects are enforcement projects prepared by a dedicated Forum Working Group and carried out by inspectors from the national authorities in participating Member States. The resulting information is collected by ECHA and the Forum Working Group, who then prepare the report on the findings of the REF project. Ultimately, the goal of RE projects is to improve the quality of enforcement by Member States and improve the compliance of registrants with the REACH, CLP and PIC regulations.

Restriction: Restrictions are instruments to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance. They can also impose any relevant condition, such as requiring technical measures or specific labels.

Authorisation: Substances that meet one or more of the criteria in Article 57 of the REACH Regulation can be identified as substances of very high concern (SVHCs). SVHCs are added to the Candidate List published on ECHA website and can be recommended for inclusion in the Authorisation List (Annex XIV), after which they are included in Annex XIV to the REACH Regulation. This means that companies need to apply for authorisation to continue using the substances after their sunset date.

Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive: The RoHS Directive aims to prevent the risks posed to human health and the environment related to the management of electrical and electronic equipment (EEE) waste. It does this by restricting the use of certain hazardous substances in EEE that can be substituted by safer alternatives. These restricted substances include heavy metals, flame retardants and plasticisers. The directive promotes the recyclability of EEE, as EEE and their components that have become waste contain fewer hazardous substances. At the same time, it ensures a level playing field for manufacturers and importers of EEE in the European market.

Toy Safety Directive: The directive on the safety of toys lays down the safety criteria that toys must meet before they can be sold in the EU. These requirements are designed to provide a high level of health and safety, to protect the public and to guarantee the free movement of toys in the EU. It identifies the particular responsibilities of different operators in the supply chain, from manufacturer to importer/retailer/distributor.

Persistent Organic Pollutants (POPs) Regulation: POPs are a group of organic compounds that have toxic properties, persist in the environment, accumulate in food chains and pose a risk to human health and the environment. Because of their persistence, these chemicals have the potential to be transported across international boundaries far from their source — through air, water and migratory species. To address the risks posed by POPs, the international community came together to conclude several agreements to reduce and eliminate these substances. The Stockholm Convention on POPs was adopted in 2001 and entered into force in 2004. It aims to protect human health and the environment from POPs. It promotes global action on these substances and requires parties and signatories of the agreement to take measures to eliminate or reduce the release of POPs into the environment.

Relevant objectives under the Chemicals Strategy for Sustainability

Minimise exposure of humans and environment to substances hazardous to health and the environment, through risk management measures and full information to users of chemicals

Return to the main pages:

Minimise and control

EU indicator framework for chemicals

Other relevant indicators and signals

REACH controls: percentage of compliant cases found in Member States (Indicator)

Percentage of REACH CLP-compliant cases found in imported goods (Indicator)

Alerts for products posing a risk to human health and the environment (Indicator)

Risks of chemical mixtures for human health in Europe (Signal)

References and footnotes

EU, 2006, 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, amending 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/EC (OJ L 396, 30.12.2006, pp. 1-849).
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EU, 2008, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance) (OJ L 353, 31.12.2008, pp. 1-1355).
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EU, 2012a, Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance (OJ L 167, 27.6.2012, pp. 1-123).
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EU, 2011, Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) Text with EEA relevance (OJ L 174, 1.7.2011, pp. 88-110).
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EU, 2009, Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance) (OJ L 170, 30.6.2009, pp. 1-37).
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EU, 2019, Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance.) (OJ L 169, 25.6.2019, pp. 45-77)
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EU, 2012, Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) Text with EEA relevance (OJ L 201, 27.7.2012, pp. 60-106).
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