The New European Chemicals Regulation
How do you objectively assess the risk of a chemical? Ever tried to compare safety data sheets on the same substance from different suppliers? What are the risk management measures you need when using a chemical in your factory? What should you do to minimise the environmental impact of a chemical when it leaves your site? Who really decides what constitutes an acceptable risk of using a chemical? Are chemical users across Europe playing on a level playing field and just where did those lists of banned chemicals come from?
In 2001, the European Commission published a white paper on the Strategy for a future chemicals policy to try and address some of these issues. After a public consultation exercise and thousands of amendments, the Registration, Evaluation, Authorisation (and Restriction) of Chemicals went through its second reading in the European Parliament on December 13 2006 and came into force on June 1st 2007. It integrates chemicals regulation in the EU, and will replace 40 existing laws and regulations. It seeks to reverse the burden of proof with regard to chemical safety so that industry, rather than public authorities, will be responsible for identifying and controlling risks associated with chemicals manufactured and imported into the EU.
As it is a regulation, and not a directive, it will be implemented across all states at the same time. Across the whole of Europe, whether you are a user of chemicals, an importer of chemicals and a manufacturer of articles, you will be impacted by REACH. The extent of the burden on the individual companies is determined very much by the position in the supply chain.
What does it all mean?
The very name itself implies the stages which any chemical manufactured or imported into the EU may have to go through. The first of these is registration.
All chemical substances produced or imported in quantities of one metric ton or more per year will have to be registered in a central database, to be managed by the European chemicals agency. This will be based in Helsinki. Some groups of substances will not have to be registered such as certain intermediates, polymers, and some chemicals managed under other EU legislation. Manufacturers and importers are required to submit a “technical dossier” containing information on the properties, uses and safe handling of the chemicals. The amount of information required is dependent upon the volume produced and the risks that a substance poses. REACH places an obligation on manufacturers to pass safety information down the supply chain. For substances manufactured or imported in quantities over 10 metric tons per year, a chemical safety report, CSR, will be required. This report includes an assessment as to whether the substance is persistent, bio accumulative and toxic (PBT), or very persistent and very bio accumulative (vPvB). For PBT and vPvB substances, the report must include descriptions of potential exposure scenarios for identified uses, along with corresponding risk management measures. To reduce costs to industry, the legislation allows registrants to form consortia which would submit information on the properties and classification of a substance on behalf of their members. This consortia is known as the Substance Information Exchange Forum (SIEF). Registration deadlines range from 3 to 11 years after REACH goes into effect, depending upon volume (3 years if >1000 tons; 6 years if >100 tons; 11 years if >1 ton).
While the registration component of REACH will clearly require the evaluation of substances by industry, “evaluation” as it is referred to in the title of the legislation entails evaluation by Member State authorities of dossiers submitted by registrants and, in certain instances, of substances themselves. One of the primary goals of this step is to review any animal testing proposals to prevent unnecessary testing. This step is also intended as a compliance check to ensure that registration materials meet the requirements of the REACH. Member State authorities may also clarify suspicions of risks to human health or the environment by requesting further information from industry.
Authorisation (and restriction)
For substances of “very high concern,” an authorisation from the EU Commission is required for use and marketing. Substances of very high concern are those which are: carcinogenic, mutagenic or toxic for reproduction category 1 and 2; PBTs and vPvBs; and substances identified as causing serious and irreversible effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters. Once it has been determined that a substance must be authorised, the registrant must apply for an authorisation, and in so doing must demonstrate that the risk from the use of the substance is adequately controlled or that the socio-economic benefits outweigh the risks, taking into account alternative substances and processes. Based on these factors, the Commission will decide whether a substance will be authorised, and can impose restrictions to ensure that the risks posed are acceptable.
Where do I go for help?
When originally published, the regulation was 843 pages in length. Given the length and the complexity of the legislation, it has been recognised that there is a need for guidance to be given to industry. The European Commission has initiated a number of REACH Implementation Programmes (RIPs) which are intended to produce best practice on a range of issues.
REACH Implementation Projects (RIPs)
RIP 1 is a description of the REACH process. The process description and flowcharts prepared under RIP 1 are available to download on the ECBs website, but it should be noted that REACH was redrafted after these were prepared and some of the article and Annex references are now incorrectly numbered.
With the large amount of data to be provided for each substance a robust IT system is required and this is the topic for RIP 2 which looks at the IT systems for the process and IUCLID 5.
Guidance on IUCLID 5 is downloadable from the Agency’s website, where you can also find a brief explanation about what the REACH IT system aims to do. To date, unfortunately, there has been no further guidance issued.
RIP 3 is of the most interest to industry and is sub-divided into a number of projects, which in some cases are sub-divided further into different guidance documents.
RIP 3.1 covering registration, intermediates, monomers and polymers and SR&D and PPORD are complete and available to download from the agency web-site
Similarly, RIP 3.4 on data sharing is available from the same site and is very new. It contains several examples of how costs might be shared. Once REACH is being practiced, however these are subject to revision at a later date.
The other RIP entirely complete and available to download is RIP 3.10 covering identification and naming of substances. This is particularly important as one of the guiding principles behind REACH is one substance, one registration aimed at minimising additional animal testing.
It is worth noting that once complete, the RIP loses its number and the guidance documents simply take on the appropriate titles. Although the guidance documents are very valuable, they are just guidance, the regulation is the binding legal document.
|Austria||Bundesministerium für Land-und Forstwirtschaft, Umwelt und Wasserwirtschaft||www.umweltbundesamt.at|
|Belgium||a) Ministère des Affaires sociales, de la Santé b) Publique et de l’Environnement||a) www.oecd.org//ehs/NewChem b) www.environment.fgov.be|
|Bulgaria||Ministry of Environment and Water||www.moew.government.bg/index_e.html|
|Cyprus||Labour Inspection Officer, Ministry of Labour and Social Insurance Department of Labour Inspection||www.mlsi.gov.cy|
|Czech Republic||Ministerstvo Zdravotnictvi CR||www.mzcr.cz|
|Estonia||Chemicals Notification Centre||www.ktk.ee|
|Finland||The National Product Control Agency for Welfare & Health||www.sttv.fi|
|France||a) Ministère de l’Environnement b) INRS, Institut National de recherche et de Sécurité||a) www.ecologie.gouv.fr b) www.inrs.fr|
|Germany||a) Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit b) Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA)||a) www.bmu.de b) www.baua.de/amst|
|Greece||Ministry Of Finance, State General Chemical Laboratory Division of Dangerous Substances and preparations||No website available|
|Hungary||National Institute of Chemical Safety, Hungary||efrirk.antsz.hu/okk/okbi|
|Ireland||Health and Safety Authority||www.hsa.ie|
|Italy||Istituto Superiore Di Sanità||www.iss.it|
|Latvia||Latvian Environment Agency||www.lva.gov.lv|
|Lithuania||Environmental Protection Agency, Department of Chemical Substances||www.infochema.lt|
|Luxembourg||Ministère de l’Environnement||www.mev.etat.lu/ra96/et1.html|
|Malta||Malta Standards Authority, Director – Foodstuffs, Chemicals & Cosmetics||www.health.gov.mt|
|Netherlands||a) Ministry of Housing, Spatial Planning and the Environment b) National Institute for Public Health and the Environment, Chemical Substances Bureau||a) www.minvrom.nl b) www.rivm.nl/bms|
|Norway||SFT, Norwegian State Pollution Control Authority||www.sft.no|
|Poland||Inspektor do Spraw Substancji, I Preparatow Chemicznych||www.bip.gov.pl/index.asp?fid=4419|
|Portugal||Direcção-Geral Do Ambiente||www.iambiente.pt|
|Romania||Romanian Ministry of Environment & Water Management||www.mmediu.ro/home/home.php|
|Slovenia||National Chemicals Bureau||www2.gov.si/mz/mz-splet.nsf|
|Slovakia||Centre for Chemical Substances and Preparations||www.cchlp.sk|
|Spain||Ministerio de Sanidad y Consumo||www.msc.es/salud/ambiental|
|Sweden||National Chemicals Inspectorate||www.kemi.se|
|United Kingdom||HSE, Health and Safety Executive||www.hse.gov.uk/nons|
There are four other RIP 3 studies which have reached their final draft stage and whose reports are also available to download from http://ecb.jrc.it/reach/rip/. These are:
- 3.2 Chemical Safety Report
- 3.3 Information requirements under REACH
- 3.5 Downstream Users
- 3.8 Substances in Articles
Further RIP 3 sub projects for which there are, as yet, no guidance documents are:
- 3.4 Pre-registration
- 3.6 Classification & Labelling Notification and GHS
- 3.7 Authorisation
- 3.9 Socio-economic Analysis
RIP 3.4 on Pre-registration would seem quite urgent and although there is no guidance document solely on this, there is some guidance given in Data Sharing.
RIP 3.6 Classification and Labelling Technical Guidance Documents have been put on hold pending adoption of the GHS Regulation proposal by the Commission.
RIP 3.7 Guidance on authorisation is stated as due at the end of this year, but there are no documents on either the Agency website or the ECBs website.
RIP 4 technical guidance documents are aimed mainly at the regulators, but may be of interest to some companies with Substances of very high concern (SVHCs.
RIPs 5 and 6 are devoted to setting up the Agency and are of limited value to industry as is RIP 7 which looks at the Commission’s preparation.
A further part of the regulation calls for each of the member states to set-up a competent authority (CA). One of the duties of the competent authority is to set-up a help desk, where companies can call for local assistance with the regulation. A full list of the competent authorities is shown in table 1.
Some trade associations have taken matters further and established commercial initiatives to help their members with REACH. Perhaps the two most significant of these are REACH Ready, established by the Chemical Industry Association in the UK, and REACH Centrum, established by CEFIC, the European Chemical manufacturers association. In addition to these, there are a number of conferences being held around Europe and a number of companies which are offering assistance with REACH compliance such as BASF and CIBA.
What should I do now?
For those in industry, the first thing to assess is whether you are affected by REACH directly. It is highly likely that you will need to take some action under REACH. REACH Ready have produced some simple guidelines which are an excellent place to start. If you are a chemical manufacturer or importer, then the guidelines in figure 1 are of relevance. If you are just, what is classed as a downstream user, then the guidelines in figure 2 are applicable.
After you have assessed the burden which REACH is going to place on your business, then it is important to determine how you are going to resource this. You may decide to use an outside consultant or you may look to run a REACH compliance programme in-house. It is important to remember that REACH is not going to go away and will play a role in future raw materials sourcing and new product development. If chemicals are a major part of this, then a more prudent investment could be to train yourself up in elements of the legislation through the Postgraduate Certificate in REACH Management at the University of Hull.
- The Regulation http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_ 39620061230en00010849.pdf
- European Commission web-site http://ec.europa.eu/environment/chemicals/ reach/reach_intro.htm
- REACH Implementation Projects http://ecb.jrc.it/reach/rip/
- REACH Ready www.reachready.co.uk
- REACH Centrum www.reachcentrum.org/
- Postgraduate Certificate in REACH Management www.etcic.com/reach.htm
Published: 10th Oct 2007 in Health and Safety International