Ask Dr Reach: Substances and preparations
QUESTION: Does a company purchasing 0.5 tonnes of substance A in preparation X and 0.5 tonnes of substance A in preparation Y need to register substance A? The questioner is a Japanese consulting company.
The answer to this question depends on where the company is purchasing the preparations from. Differences between EU and non-EU sourcing of products are raising concerns over the trade implications of REACH. When a company purchases a product from outside the EU, it must follow registration requirements as an importer. In most cases, importers must therefore know the detailed compositional data of products, even if a substance is below one tonne in a preparation. This is because importers need to aggregate the tonnage of any given substance across product lines.
By comparison, a company purchasing a product from within the EU does not need to pre-register or register substances contained in the product. For this reason, the company does not necessarily need to know compositional information (unless necessary for a Safety Data Sheet, article communication, safety assessments, etc). The only exception is if it is a producer of an article where that substance will be intentionally released from the article.
Of course, the obligations of EU importers can be met by Only Representatives appointed by non-EU manufacturers, formulators and producers of articles. Crucially, when carefully devised and implemented, the ‘only representative’ (OR) scheme can avoid disclosing compositional data. Given the question, the following scenarios could occur:
- Company purchases preparations X and Y from outside the EU. It must pre-register and register substance A.
- Company purchases preparations X and Y from the EU. It does not need to pre-register and register substance A.
- Company purchases preparation X from in the EU and preparation Y from outside the EU. It does not need to pre-register and register substance A unless it is contained above 0.5 tonnes in other non-EU sourced products that it purchases.
- Company purchases preparation X and Y from outside the EU. Preparation X is covered by an OR. It therefore does not need to pre-register and register substance A unless it is contained above 0.5 tonnes in other non-EU sourced products that it purchases.
These examples are non-exhaustive. However, a critical conclusion can be drawn: appointing an OR can be important to companies wanting to ensure that a substance below one tonne remains exempt for its EU customers. Current understanding is that an OR can cover a substance below one tonne in a preparation. In such an instance, the tonnage of that substance can be excluded from aggregated tonnage calculations of the substance from other supplies across the importer’s product portfolio.
Send questions to Dr Steffen Erler and read his previous answers http://chemicalwatch.com/dr_reach
BOX: Legal Disclaimer
The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.
