Registration, Evaluation and Authorisation of Chemicals
On 29 October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals – commonly know as REACH . This is probably one of the biggest and most important developments in chemical legislation for many years; the media certainly seemed to think so, with unprecedented coverage of the development. (For all REACH documents see the “ Europa” website).
It is estimated that only about 10% of all chemicals on the market have undergone full and stringent testing, with many of these substances having been used in everyday household products.
REACH will require companies manufacturing or importing chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. REACH will also reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.
An underlying aim of REACH is to phase out 'substances of very high concern' i.e. those that may cause cancer or damage genetic material, and to replace them with safer alternatives.
The proposed Regulation would also replace over 40 existing Directives and Regulations.
How many substances are affected?
• Registration : The European Commission estimates that around 30,000 marketed substances will need to be registered (of these, around 20,000 are produced or imported in volumes of between 1 and 10 tonnes). Also, approximately 40,000 intermediates will also need to be registered although for most of them the registration requirements will be significantly lighter than for other substances.
• Evaluation : It is estimated that about 20% of the 30,000 would go through this process.
• Authorisation : Up to 1500 substances of very high concern will be subject to authorisation.
Would REACH apply to you?
If you manufacture or import more than 1 tonne of chemical substance per year, you would be required to register it in a central database.
Some substances used in pesticides, cosmetics and pharmaceuticals will be included, but others will continue to be covered under existing EU legislation.
As for preparations (mixtures, for example, paints), REACH is substance based and it is the substances in preparations that will need to be registered, not the preparations themselves.
A new European Chemicals Agency is being established to setup and manage the core elements of REACH. The Agency will be funded mainly through fees charged for registrations and authorisations.
The Agency will setup the database of registered substances and will co-ordinate the evaluation procedures. It will also liaise with and advise the European Commission.
The European Commission see the manufacturers and importers role as follows: “[they] will be required to gather information on the properties of their substances, which will help them manage them safely, and submit the information in a registration dossier to a central data base. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer. [The European Chemicals Agency] will receive the dossiers and manage the database. Information requirements will largely depend on volume, but may be tailored to the intrinsic properties and conditions of use of certain substances
Registration will involve providing information on:
• The intrinsic properties and hazards of each substance (such as physicochemical, toxicological and eco toxicological properties). This information if not already available can be found through a variety of means such as computer modelling and epidemiological studies, or through testing. Where testing is necessary and involves animals, it will be kept to a minimum by requiring companies to share existing data. This will also reduce the associated costs. Any proposals for testing on animals will also be subject to a 'dossier evaluation'.
• The use(s) of the substance identified by the importer or manufacturer or by their customers. A report of an assessment of risks for human health and the environment, and how those risks are adequately controlled, for the identified uses for substances produced or imported in volumes of 10 tonnes or more per year per manufacturer or importer (known as chemical safety reports). For lower volumes, safety information produced for the safety data sheets will be submitted as part of the technical dossiers.”
There will be two types of evaluation: dossier and substance evaluation which will both be performed by competent authorities in the Member States. The European Commission comments:
• Dossier evaluation will be conducted to check proposals for testing on animals and ensure that unnecessary animal testing is avoided. Registration dossiers can also be subject to a dossier evaluation to ensure their compliance with the registration requirements.
Substance evaluations can be performed when there is reason to believe that a substance may present a risk to human health or the environment (for example, because of its structural similarity to another substance or for other reasons). Therefore, substance evaluations will look at all the registration dossiers submitted for the same substance and take into account any other available information. It is expected that substance evaluations will focus on those substances
• that may pose the greatest risk to human health and the environment. The Agency will develop risk-based criteria to assist with the prioritisation of substance evaluations.
Only substances of very high concern will be subject to authorisation and will apply to particular uses of the substance in question. The Commission comments:
“Authorisation will be granted only if the producer or importer can show that risks from the use in question can be adequately controlled, or that the socio-economic benefits of the use of the substance outweigh the risks. In the latter case, the possibility of substitution should be considered.
The authorisation decision will take into account substitution plans showing for example that the industry is researching substitutes. Third parties will also be able to provide information to the Agency about possible substitute substances or technologies.
Examples of substances that will be subject to authorisation are:
• CMRs (carcinogenic, mutagenic or toxic to reproduction), category 1 and 2,
• PBTs (persistent, bio-accumulative and toxic),
• vPvBs (very persistent, very bio-accumulative).
• Substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories, for example certain endocrine disrupting substances (substances disturbing the body's hormone system). These will be identified on a case by case basis and be subject to authorisation.”
The proposal will now be forwarded to the European Parliament and the EU's Council of Ministers for adoption under the so-called co-decision procedure.
For more information:
For more information on REACH and its effects on your business, contact the NCEC