Anyone wishing to export chemicals to the European Union invariably comes across the great wall of Europe in the form of REACH, the most complex legislation with a documentation of some 849 pages.
REACH stands for Registration, Evaluation, Authorization and Restriction of Chemical Substances, a regulation that was enacted in December 2006 and which became one of the strictest in the world. It came into force in June 2007. Any manufacturer or supplier wishing to trade with EU buyers must necessarily comply with and prepare the REACH safety data sheet for each chemical. The only mitigating factor for suppliers and buyers is that REACH becomes applicable when the quantity exceeds a ton or more in a year. This is of little consolation, as the major providers cross this boundary. Quantities greater than 1 ton but within 100 tons must be recorded within 11 years and quantities greater than 100 tons must be recorded within 6 years. Suppliers must provide risk assessment and control measures for user safety.
It is complex and preparing REACH compliant SDS requires a thorough knowledge of the regulations. They are complex and difficult, as well as expensive to comply with. One area where they go beyond normal guidelines is the impact of chemicals on human health and the environment. When using chemicals that are identified as of high concern in a formulation, the manufacturer must work to find a less hazardous alternative. Another requirement is that hazards must be communicated up and down the supply chain to ensure that importers, manufacturers, and downstream users are familiar with the hazards and take precautions for safe use and disposal. The evaluation process is also strict, including dossier evaluation and substance evaluation in the event that a substance poses a risk to human health and the environment. It is then licensed based on findings that the substances have established controls or are adequately justified for their use. REACH has guidelines for cosmetics, pesticides, biocides, and even toys. Substances must be registered with the authority before importing them into the EU. Compliance documents and submissions must be made using the IUCLID software provided free of charge in electronic format.
There are other complications as well. REACH data sheets and labels must be available in the local language of the country to which the substances are exported. Documents must comply with both REACH and EU CLP. Then there is the verification process. Disclosures must be made in their entirety. A manufacturer may wish to keep a proprietary formula secret, in which case exemptions should be sought. The process also includes the participation of SIEFs that cover data gap analysis and confidentiality measures.
As can be seen, the process is complex and requires expert knowledge of the guidelines and processes involved. Manufacturers / suppliers would benefit from engaging the REACH compliance and dossier preparation expert as well as filing services. Experience and familiarity with the process, the ability to translate, and being available to resolve any queries give professionals an edge in providing impeccable services.