Declaration of Compliance
Product certification for Europe to export any product to the EU markets
In order to legally place your product on the EU market, the chemical content of your products must be clarified, and the necessary measures taken.
The Declaration of Compliance document prepared by Chementors Ltd proves that your product is safe and legal.
Furniture, clothes, shoes, toys, jewellery, laptops, containers… any of these products is considered “an Article” in EU REACH legislation. Meaning that EU REACH affects your business!
The EU’s chemical landscape is well regulated. Certain substances, for example those of very high concern (SVHC) can cause adverse effects throughout their life cycle on the people involved in the supply chain and on the environment. Therefore, the EU has sets of different chemical regulations to protect all parties involved in the supply chain of chemicals.
As a part of the fulfillment of the EU’s safe and sustainable chemicals ambition, EU importers and EU manufacturers now have obligations according to the REACH Regulation ((EC) No 1907/2006) and the Waste Framework Directive (2008/98/EC) which requires the determination of chemicals contained in their products. During this process it is important to submit a SCIP notification to the European Chemical Agency (ECHA, if certain regulatory criteria are met.
Failure to comply may have a negative impact on the business reputation because of impending penalty actions by the regulatory authorities. Therefore, to protect business interests and prevent financial losses, every producer, assembler, importer, and distributor of articles/products should comply with these legal obligations.
IMPORTANT! The Waste Directive requires a SCIP notification of the product on ECHA’s portal if the SVHC content of any component of the product exceeds 0,1% by weight. In this case a laboratory test result alone is not sufficient.
CLARIFY! Does your product contain regulated substances or substances of very high concern? Does the product contain such substances that are released during normal use, or during the lifecycle of the product?
The requirements for the safe use of your products may differ case-by-case. Therefore, it is also a recommended business strategy to have the Declaration of Compliance prepared even if the product does not contain the above-mentioned substances. We provide your business with a tailored compliance solution based on your needs. It is also good to keep in mind that having compliance with the different EU chemical regulations will give your business a definitive advantage in the EU market.
CHEMENTORS can assist you by determining the chemical content of your products and by handling the legal obligations, such as the SCIP notifications. As a result, we will provide you a certificate of your products for your stakeholders and customers. The certificate will confirm that your products meet the requirements of the EU laws and are safe for the intended use.
Steps to product certificate for Europe (DoC)
- Gather the necessary information about all the chemicals in your products from the product development and procurement departments and any other parties in the supply chain if needed.
- Safety data sheets, BOM check, analysis certificates, various product databases, etc.
- Does your product contain any ingredient (or mixture) that is intended to be released / dissolved / evaporated from the product during use? In this case, the substance may need to be registered under REACH under Article 7 (1) if the export into the EU exceeds the annual limit of one ton (1000 kg / year).
- Does your product contain substances with restrictions on use? (Annex XVII of REACH contains a list of chemicals with restrictions or prohibitions on use of certain dangerous substances, mixtures, and articles)
- The use of restricted substances in the product will prevent placement on the market.
- Does your product contain SVHCs? The SVHC candidate list is updated twice a year. Ask Chementors or the European Chemicals Agency (ECHA) for updated information. There are currently 224 substances on the SVHC candidate list (as of 10th June 2022).
- If an SVHC substance is present in an article above 0.1% weight, the article should be notified to ECHA by submitting a SCIP-notification. The marketer should also provide information on SVHCs and safe use of the product to EU importers, distributors, supply chain parties and consumers.
- If a product contains SVHC more than 0.1% weight and the amount of that substance in the product exceeds one ton per year (1 t / y) per producer or importer, a separate notification of import or manufacturing of the product must be submitted to ECHA.
- Similarly, if a chemical in a product is nominated as an SVHC candidate by ECHA, the notification period to ECHA is six months from the candidate listing.