Regulation

REACH Regulations for registration of chemicals in EU

The REACH regulation, to be implemented from June 1 this year, gives greater responsibility to industry to manage risks from chemicals and to provide safety information on substances. Manufacturers of chemical based companies who supply to EU based clients will have to register their chemicals under this regulation

Parminder Kaur

REACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. It came into force on 1st June 2007 and replaces a number of European Directives and Regulations with a single system.

REACH covers both "new" and "existing" substances. The new regime also creates a European Chemicals Agency in Helsinki, Finland and amends currents legislation. The Existing Substances (Regulation 793/93/EEC) will continue alongside REACH for one year in order to help facilitate the transition to REACH, and then be replaced from 1 June 2008. Similarly the Marketing and Use Directive (76/769/EEC) will continue for two years until 1 June 2009 and then also be replaced.

The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.

Aims of REACH

REACH has several aims:

• To provide a high level of protection of human health and the environment from the use of chemicals.
• To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
• To allow the free movement of substances on the EU market.
• To enhance innovation in and the competitiveness of the EU chemicals industry.
• To promote the use of alternative methods for the assessment of hazardous properties of substances ie. QSAR (Quality safety assessment report) and read across.

No Data, No Market

A major part of REACH is the requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency. A registration package will be supported by a standard set of data on that substance. The amount of data required is proportionate to the amount of substance manufactured or supplied.

If substances are not registered, then the data on them will not be available and as a result, the manufacturing or supply will no longer be permitted, ie. no data, no market!

Who is impacted by REACH?

REACH applies not only to chemical companies (either manufacturer or importer), but to all sectors using chemicals. Electronic and electrical equipment, automotive, aerospace, cosmetics, textiles, and paints are just a few examples of sectors that will be impacted by REACH.

Exemptions

Some industrial sectors and chemical substances are excluded from or are temporarily exempt from REACH so as to avoid overlap with other EU regulations or conflict with regulations that are specific to the industrial sector. Industry sectors or substances excluded or exempted from REACH include:

Excluded from REACH regulation due to low quantities produced:

• Chemical volumes produced in less than 1 tonne/year
• Additives in polymers if presence is less than two percent

Excluded from REACH because other EU regulations already apply:

• Pharmaceuticals
• Pesticides
• Food additives
• Flavouring in food products
• Agricultural feed additives
• Animal nutrition
• Waste
• Radioactive substances

Exempted from REACH for practical reasons:

• Non-isolated intermediates

Temporarily exempt:

• Chemicals used in research
• Polymers (however, the Commission may introduce requirements for the registration of polymers once a practicable and cost-effective method of safety evaluation has been established)

Registration

Registration is a requirement on industry (manufacturers/importers) to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above one tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki.

Evaluation

Dossiers submitted in support of registration will be subject to evaluation under REACH as follows:

• Compliance checking: This is a check of the quality of the information submitted by industry. It will be undertaken by the European Chemicals Agency (ECHA) in Helsinki and will be on a sample (at least five percent) of dossiers submitted at each tonnage level.
• Dossier Evaluation: For substances registered at the highest tonnage levels (=100 tonnes/annum) a proposal is made by the registrant detailing those animal tests they consider are required from the list of standard tests. The ECHA will evaluate these testing proposals to prevent unnecessary animal testing.
• Substance evaluation: This is undertaken by national Competent Authorities on substances that have been prioritised for potential regulatory action because of concerns about their hazardous properties. A key regulatory outcome of evaluation could be the imposition of restrictions on the manufacture, supply or use of a substance. Substance evaluation may also lead to a substance being added to the priority list for authorisation or a proposal to change the classification and labelling.

All dossiers will undergo an automated completeness check to ensure that all the relevant pieces of information are present. This completeness check will not assess the quality or suitability of the information.

Authorisation

In order to place on the market or use substances with properties that are deemed to be of "very high concern" industry must apply for an authorisation. The European Chemicals Agency (ECHA) in Helsinki will publish a list containing substances to be considered for the authorisation process by 1 June 2009. A company wishing to market or use such a substance must submit an application to the ECHA for an authorisation. The European Commission makes decisions on authorisation. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyse whether there are safer suitable alternatives or technologies. If there are then they must prepare substitution plans and if not then they should provide information on research and development activities if appropriate.

Substances of Very High Concern

Some substances have hazards that have serious consequences, eg. they cause cancer (carcinogenic), or they have other harmful properties and remain in the environment for a long time (persistent) and gradually build up in animals (bio-accumulative). These are 'substances of high concern'. This category also includes substances demonstrated to be of equivalent concern, such as "endocrine disruptors". One of the aims of REACH is to control the use of such substances via authorisation and encourage industry to substitute these substances for safer ones.

Information in the Supply Chain

The passage of information up and down the supply chain is a key feature of REACH. Users should be able to understand what manufacturers and importers know about the dangers involved in using chemicals and how to control risks. However, in order for suppliers to be able to assess these risks they need information from the users about how they are used. REACH provides a framework in which information can be passed both up and down supply chains.

REACH adopts and builds on the previous system for passing information - the Safety Data Sheet. This should accompany materials down through the supply chain, providing the information users need to ensure chemicals are safely managed. In time these safety data sheets will include information on safe handling and use.

Restrictions

Any substance that poses a particular threat can be restricted. Restrictions take many forms, for example, from a total ban to not being allowed to supply it to the general public. Restrictions can be applied to any substance, including those that do not require registration.

Classification and Labelling

An important part of chemical safety is clear information about any hazardous properties of a substance. The classification of different chemicals according to their characteristics (for example, those that are corrosive, or toxic to fish, etc.) currently follows an established system, which is reflected in REACH.

Registration Options for Non-EU "Only Representative (OR)"

Although companies from outside the EU cannot register substances themselves directly, there is a provision in REACH Directive, which allows chemical manufacturers from outside the EU to appoint a person or company based in the EU to act as their "Only Representative".

Only Representative

The only representative will take on the obligations under REACH, which would otherwise fall on the EU importer(s).

A non-EU manufacturer may choose to appoint an only representative, rather than have their importer register the substances, in order to have more control over the registration process without having to disclose potentially sensitive information to an importer.

For EU importers this may have advantages, if the non EU manufacturer nominates an only representative to register the substances they export to the EU, the importer will be relieved from the obligation to act as the registrant under REACH and will be regarded as a downstream user.

References

• Regulation 1907/2006/EC ( "REACH Regulation").
• Directive 2006/121/EC contains technical adaptations of Directive 67/548/EEC
• Directive 67/548 concerning classification, packaging and labelling of dangerous substances and applies in parallel to REACH Directive.

(The author is a regulatory affairs consultant based in The Netherlands and can be contacted at parminder.kaur@consultant.com)