Article 1 April 2016

Enforcement of REACH authorisation has started!

The network of EU Member States' enforcement authorities – by its formal name The Forum for Exchange of Information on Enforcement ("Forum") – has conducted a pilot enforcement project in the sphere of REACH authorisation. It found a low level of non-compliance with respect to the two substances appraised: out of 235 companies inspected in 18 Member States, three cases of breach of the rules were found. Fines were imposed on one of the infringing companies. Of the inspected companies, the great majority were downstream users.

Background on the REACH authorisation process

The REACH provisions on authorisation aim at ensuring the proper control of risks flowing from substances of very high concern ("SVHC") and the progressive replacement of such substances by suitable alternatives and technologies where economically and technically viable.

Following a process of, first, identifying and including SVHCs on the Candidate List for Authorisation, ECHA recommends to the European Commission the inclusion of Candidate List SVHCs into the Authorisation List. The list is, in essence, an Annex to the REACH Regulation that is updated whenever the European Commission places a new substance on the Authorisation List. Once on the Authorisation List, the use of the substance will be prohibited after a specific date (the so-called sunset date), save for where an exemption applies or an authorisation has been granted by the European Commission for one or more specific uses.

In accordance with Article 56 of the REACH Regulation, a manufacturer, importer or downstream user shall not place on the market for use a substance that is included on the Authorisation List. However, the following exceptions apply. First, where the specific use of the substance, (either on its own, in a mixture or incorporated into an article), has been authorised by the European Commission in accordance with the provisions and process provided for in the REACH Regulation, a substance from the Authorisation List can be placed on the market.

Second, the use (again, on its own, in a mixture or in an article) has been exempted from the authorisation requirement. Further, use is permitted until the sunset date has been attained (or even post-sunset date where the decision-making process for a timely application for authorisation has not yet been completed).

Finally, a substance on the Authorisation List may be placed on the market where an authorisation has been granted to the immediate downstream user.

Moreover, the use of substances in scientific R&D is altogether exempted, while the European Commission's decision placing a substance on the Authorisation List may exempt process and product orientated research and development (so-called PPORDs). Finally, the provisions on REACH authorisation should not, in principle, apply to certain intermediate substances.

Forum's pilot project on enforcement of REACH authorisation

The Forum is established pursuant to the REACH Regulation, and co-ordinates, as its main task, the network of Member States' authorities responsible for the enforcement of REACH obligations. In the pursuit of this objective, the Forum, inter alia, co-ordinates and evaluates harmonised enforcement projects and joint inspections as well as identifies enforcement strategies and best practices for enforcement.

The Forum's pilot project on the enforcement of REACH authorisation was limited to two specific substances on the Authorisation List, namely MDA (4,4'-Diamoniodiphenylmethane) and musk xylene. The sunset date for these two substances expired in August 2014 with no authorisations having been granted for their use. The focus of the pilot enforcement project was to check whether these two substances were present on the market beyond the sunset date of August 2014.

On-site inspections were conducted in the first half of 2015. A total of 235 companies were inspected in the 18 participating Member States. A narrow majority (52%) of the companies inspected were manufacturers of chemicals and chemicals products, while 26% were manufacturers of non-chemical products and the remaining 18% were active in the wholesale and retail level of the trade. In terms of the companies' role pursuant to the REACH Regulation, the vast majority, 81%, were downstream users.

Of the 235 companies inspected, the enforcement authorities found three instances of non-compliance, all relating to musk xylene. More specifically, out of eight companies that were active with musk xylene (either by placing it on the market or using it), two companies were found to have placed the substance on the market, and one downstream user was found to have made use of it, in breach of Article 56 of the REACH Regulation. The other companies were found to have placed on the market, and used, the substance for an exempted use.

Sanctions were imposed on the three companies found to have breached the prohibition of Article 56 of the REACH Regulation. These included a fine in one instance and the issuing of written advice and administrative orders in two others.

In addition to the specific objectives related to the two individual substances, the aim of the pilot project was for the authorities to gain experience and to build practice and processes for the enforcement of REACH authorisation-related obligations. The pilot project and its conclusions give reason to believe that the national authorities may intensify their enforcement action. In this context, it is worth noting that downstream users may very well find themselves in the focus – if the pilot project is anything to by.

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