EU REACH Record Keeping Requirements 101 — What You Need To Know

EU REACH Record Keeping Requirements 101 — What You Need To Know

Companies placing products on the market in the European Union have long recognized that complying with the legislation is just another part of managing the business process and, because speed to market is usually a key factor, resources are assigned to ensure that it is achieved as quickly as possible. The company manufacturing or importing the product take the time to understand the legislation and, whether it be a chemical substance or mixture falling within the scope of the REACH Regulation, or a skin care product falling within the scope of the Cosmetic Regulation or a biocide falling within the scope of the Biocidal Product Regulation, they ensure that the products are registered or authorized before they are placed on the market in the European Union. Some products fall by the wayside at this stage and are withdrawn but others are successful and remain on the market for many years and companies then maintain the registration to satisfy the requirements laid down in the legislation.

In the European Union, the responsibilities don’t end when the product is withdrawn from the market and, using the EU REACH Regulation as an example, manufacturers, importers, downstream users and distributors still have to assemble and keep available the information required to carry out their duties for a period of at least ten years after the product was last manufactured, imported, supplied or used. The responsibility is very broad and what is often forgotten is that the record keeping responsibilities also include any downstream users or distributors of the product concerned. The records have to be kept by all the companies concerned for at least 10 years and have to be made available without delay upon request to any competent authority of the Member State in which the company is established or to the European Chemicals Agency.

For companies manufacturing, importing or using the substance or mixture, maintaining the records for ten years is resource intensive and can exceed the time many companies currently store their business records for and is not just limited to the REACH Regulation. Many other regulations, e.g., those dealing with biocides and cosmetics, also have similar requirements. The wording used may be different, but both the above regulations require companies to maintain their records for ten years. For biocides it is after the date on which the authorisation was either cancelled or expired and, for cosmetics, it is ten years following the date on which the last batch of the cosmetic product was placed on the market in the European Union!

Complying with the requirements in the legislation is necessary and not difficult. Putting a plan in place before the product is withdrawn from the European Union market is important because it may involve changing company record retention policy and require resources to be assigned when the product is no longer generating any revenue for the company.

About the Author: Barry Podd —Spent 26 years in the Chemical Industry in various positions in Research and Development, Marketing, Sales and the Regulatory Affairs. Barry joined Kimberly Clark in 2005 and was Associate Director Global Regulatory Affairs responsible for Chemical and Food Contact Management issues around the world until he retired at the beginning of 2013. Active in a number of Trade Associations, e.g., EDANA, CEPI and the European Tissue Symposium [ETS] and, even though retired, still speaks regularly at conferences on biocides, chemical legislation and food contact.

Photo credit: indi.ca Commons License Flickr

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