EC Regulation No. 1907/2006 (REACH) is an important element of European environmental legislation, regulating the use and management of chemical substances.
This legislation, which is essential to protect human health and environment, required new responsibilities to the industry, by shifting the burden of proof regarding the safety of chemical sunstances from national authorities to manufacturers and importers.
What Reach provides:
– Registration: Manufacturers and importers are required to collect data on chemicals produced or imported in excess of one tonne per year by registering this information in the ECHA (European Chemicals Agency) database.
– Assessment: Potentially harmful substances are evaluated to identify and manage associated risks. Evaluations are conducted by Member States and coordinated by ECHA, with the evaluated substances listed in the Community Rolling Action Plan (CoRAP).
– Authorisation: Substances deemed to be of very high concern (SVHC) are subject to an authorisation process which may restrict or prohibit their use in the EU market without the approval of the European Commission.
– Restriction: This mechanism imposes restrictions on the use, production and marketing of certain harmful substances, regardless of quantity.
Packaging and REACH
According to REACH regulation, packaging falls within the definition of “article” when its shape, surface or design define its function more than its chemical composition.
This means that packaging is subject to the same REACH rules as other articles, including:
- Notification to ECHA by the manufacturer or importer for SVHCs (Substances of Very High Concern) released from articles if:
– Exposure to humans or environment cannot be excluded under normal or reasonably foreseeable conditions of use, including disposal;
– the substance is present in such articles in quantities overall exceeding one tonne per producer or importer per year;
– the substance is contained in such articles in concentrations > 0.1% w/w.
- Communication by the supplier to the recipient of the article about the presence of SVHC substances, if the substance is present in such articles at a concentration above 0.1 % weight/weight (w/w), and about the information on the substance to allow the safe use of the article.
- Communication by the supplier to the recipient of the article about information relating to substances restricted in Annex XVII.
Companies must therefore consider packaging as a separate article with all the related regulatory implications. This requires careful evaluation of the materials used and the substances potentially released to ensure product compliance and safety.
Understanding and implementing the provisions of REACH regulation are crucial for the packaging industry, as they not only affect production and marketing but are also crucial for environmental and consumer protection.