Reaching round Europe – the implications of REACH legislation

Materials World magazine
,
1 Aug 2008

New laws surrounding chemicals in materials will soon have a big impact on the trade of goods in the European Union. Here Jim King, Principal Inspector at the Health and Safety Executive in Northern Ireland, UK, discusses the implications.

The European Union (EU) is implementing a new chemicals regime that will have a significant impact on companies across the materials import and manufacturing sector. The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a regulatory framework as required by Regulation (EC) No. 1907/2006. The first deadline for compliance – ‘pre-registration’ of existing (so-called ‘phase-in’) substances – expires on 30 November.

Some 30,000 existing chemical substances, used on their own, in preparations or incorporated into finished articles, will be affected. Manufacturers or importers who fail to pre-register a phase-in substance must suspend marketing of that substance pending complete registration and may face penalties. A key impact of REACH is the transfer of responsibility for the generation and assessment of data on the safety of chemical substances from Government to those putting them on the EU market.

These regulations will provide more extensive, transparent, hazard and risk data on substances. This will be achieved initially by requiring registration of all substances manufactured or imported in quantities of one tonne or more per year. Registration with the newly established European Chemicals Agency (ECHA) will require submission of detailed information about the substance, its uses, related risks and guidance on safe use. Transparency also means making information available throughout the supply chain and to end users, such as data on dangerous substances (substances of very high concern [SVHC]) in the finished products they purchase. Substances of very high concern are defined as carcinogenic, mutagenic or toxic to reproduction classified in category 1 or 2 under the Chemicals Hazard Information and Packaging for Supply Regulations 2002, persistent, bioaccumulative and toxic or very persistent and very bioaccumulative as defined in REACH.

On the register

Registration responsibility is placed on manufacturers (M) within the EU and on importers (I) of substances into the EU. The duty is phased over time, depending on the hazards or the quantity of material being placed on the market, with registration of the most hazardous and/or highest quantity materials being required by 1 December 2010.

Access to the phased timelines is dependent on the M/I pre-registering the substance with the ECHA between 1 June 2008 and 30 November 2008. Requirements for pre-registration are not extensive – name of substance, the European Inventory of Existing Chemical Substances number, the name of legal entity, foreseen deadline for registration and tonnage band. This will be done electronically.

Users of chemicals, known as downstream users (DUs) – distributors, formulators (considered DUs), even retailers – while not required to register substances, have duties to supply information up and down the supply chain and to use substances in the manner approved by the registrant. Only companies with a legal presence in the EU will be able to register directly. Manufacturers outside the EU cannot register by themselves but can appoint an ‘Only Representative’ to ensure proper registration to protect their market.

Substances can include metals in massive form, constituents of alloys, and pure or impure chemicals, but not polymers. However, the constituent monomers do have to be registered and therefore pre-registered to meet the phased timelines. Only a few classes of substances are exempt from REACH registration, such as waste materials or pesticides, which are covered by the Plant Protection Directive.

Risky business

If properly pre-registered, the extended registration deadlines for phase-in substances are shown in the table (below).

Date

Action

1 Dec 2010

Deadline for registration of substances > 1000tpa, VT to aquatic organisms > 100tpa, CHIP CAT 1 or 2 CMR > 1tpa

1 June 2013

Deadline for registration of substances >100 tpa

1 June 2018

Deadline for registration of substances > 1tpa

 

Cases may arise where a manufacturer or importer has failed to pre-register a substance, or has decided that it is not commercially viable to continue with production or import. Those businesses which have particular concerns about continuity of supply because they use an unusual chemical or a common one in an unusual way may wish to consider contacting suppliers to find out whether those responsible for registering the substance(s) will be meeting their obligations under REACH.

The ECHA must publish a list of the pre-registered substances by 1 January 2009 and DUs can identify whether the substance of concern has been pre-registered. The DUs of a substance essential to their production process that has not been pre-registered can ask the ECHA to help them find a supplier or allow them time to pre-register the substance themselves as a first time M/I.

Phase-in substances that should be registered, but miss the pre-registration period, become subject to the ‘no data, no market’ rule. The substance is barred from the EU market until properly registered. The company may also face penalties under national law for the marketing that took place between the start of the pre-registration period and the suspension of marketing.

All shapes and sizes

For substances in articles, a special regime applies. An article is the legal term under REACH for any object that has been given a specific shape, surface or design so that it can be used for a specific purpose, such as manufactured goods such as cars, textiles and electronic chips. Registration of substances in articles is only required if there is intended release.

In addition, from June 2011, all substances included in the candidate list for authorisation and which are present in articles above a concentration limit of 0.1% w/w and above one tonne per year must be notified to the Agency, except when exposure to humans and environment can be excluded during normal conditions of use, including disposal, or it is already registered for that use. Notification of a substance in an article consists of sending a dossier to the Agency containing the identity of the notifier, the identity of the substance, its classification and labelling, a brief description of its use and the tonnage range.

As a safety net, the Agency can require that a substance in an article be registered at any time if it considers that the substance’s release poses a risk to human health or the environment. Retailers who supply articles containing more than 0.1% of a SVHC have to pass on sufficient information to recipients to allow safe use of the article.

Cause for concern

The SVHC will be gradually included in Annex XIV of the REACH regulation. Once included, they cannot be placed on the market or used after a certain date (called the sunset date) unless the company is granted an authorisation. There is no tonnage threshold for a substance to be subject to authorisation.

Member State Competent Authorities or the ECHA can identify a SVHC by preparing a dossier of information. Once in the Annex, industry can apply for authorisation of use by submitting a dossier to the ECHA. Interested parties can comment at all stages in the process of deciding whether the European Commission should issue authorisation, which will be granted if industry can demonstrate that the risk from the use of the substance is adequately controlled or that the benefits outweigh the societal risks. Downstream users may only use chemicals if properly authorised.

It is prudent for M/I to pre-register their substances to preserve the possibility of using the transitional deadlines. Users should check with their suppliers that business critical substances will continue to be available.

 

Further information:

Health and Safety Executive