A harmonized system for product notifications across the EU – timeline, procedure and pitfalls
Classification, labeling, and packaging (CLP) of substances and mixtures according to Commission Regulations (EC) No 1272/2008 and (EU) 2017/542
Date: 29 May 2020
In order to protect consumers as well as the environment from potentially hazardous properties of chemical products, a harmonized classification, labeling, and packaging strategy was introduced in the EU with Regulation (EC) No 1272/2008. In particular, it defines that manufacturers, importers as well as downstream users are legally obliged to provide comprehensive information on their products (e.g. toxicological information, chemical composition) to the authorities. This is also relevant for information provided on MSDS (material safety data sheets) and requires expert consultation.
The legal foundation of these product notifications is defined in Article 45 of Regulation EC (No 1272/2008) introduced above. Due to differences in the realization of the European regulation in EU member states, harmonization and validity of product notifications across the EU has however been limited. This problem has been addressed with the implementation of Commission Regulation (EU) 2017/542 amending CLP Regulation (EC) No 1272/2008. This amendment (often simply referred to as Annex VIII CLP) defines a harmonized format for notifications of products for submission to the appointed bodies in each member state. With this Annex, not only the content, but also the technical format has been clearly defined in a legally binding way. In a first revision to Annex VIII dated January 2020, adjusted compliance dates for product notifications have been published for professional use products (January, 1st 2021) and for products for industrial use (January, 1st 2024). Please note that January, 1st 2021 applies to plant protection products.
Key aspects that need to be included in the new product notifications include for example a product specific UFI code (Unique Formula Identifier) as well as more comprehensive toxicological information, and a new Product Category System (PCS). ECHA (European Chemicals Agency) provides a tool which assists in the generation of UFI-codes and additionally, user-guides with detailed information on the procedure of UFI-Code generation and PCS are available for download from https://poisoncentres.echa.europa.eu.
Submission of product notifications may be done using the new EU harmonized Poison Centres Notifications Portal (PCNP) which facilitates submissions to more than one EU country. Currently, this new system is however only in place in Estonia and Germany, and harmonization across all EU countries has not yet been implemented. Thus, product notifications shall be done using the respective national notification portals and guidelines until December 31st 2020.
A guidance document for the correct preparation of product notifications according to the new PCN (Poison Centre Notification) format is available for download from ECHA, too.
Common mistakes by notifiers that occurred in the past include, among others, incomplete data on product/mixture composition, incomplete information regarding e.g. hazard statements, CAS number, and inconsistent data sets.
Even though the new system for product notifications is still in its infancy and currently only available in Germany and Estonia, it has the potential to provide a straightforward EU-wide harmonized system for product notifications which will make processes more efficient, and additionally will facilitate the acceptance of product notifications across the EU.
Alexander Feyrer