Companies struggling to meet the European Union’s (EU’s) new revamped regulations regarding the classification, labeling and packaging (CLP) of substances and mixtures in products intended for use by consumers have been granted a short reprieve. But parties that are obligated to submit CLP information to EU poison centers still have a lot of work to do to determine what product information they need to submit to comply with the EU’s new reporting requirements.
“Ensuring compliance with CLP requirements was challenging even before the EU’s latest revisions,” said Dr. Ancuta Rusu, a UL regulatory specialist based in Brussels who has been closely following the evolution of CLP regulations in the EU.
“The changes implemented under the Commission’s 2017 Implementing Regulation directly affect how products are labeled and marketed, further complicating the process for manufacturers, importers and others.”
In brief, EU regulations require parties that place mixtures that pose physical and/or health hazards on the market to submit detailed information on those mixtures to “appointed bodies” in applicable EU member states. Those bodies then pass that information along to designated poison centers, which are responsible for providing timely information on potential medical risks to first responders and others in the event of an emergency.
Published March 2017, Commission Regulation (EU) 2017/542 introduced two important changes in existing EU CLP regulations. First, the regulation replaces individual national reporting requirements with a single, harmonized format for submitting information to appointed bodies. Information required under the harmonized format covers four key areas, including product details, information on the mixture, a unique formula identifier (UFI), and details on the party submitting the information.
Second, the regulation also mandates that parties provide the relevant UFI on the label of their products, to create a clear and unmistakable link between the product and the information on file with poison centers.
The harmonized format will mean that submitting parties will be able to prepare a single profile for each of their hazardous mixtures instead of having to customize information to meet the unique requirements of each national appointed body. Furthermore, direct access to a UFI on the product label will allow poison center contacts to provide the most accurate information on hazardous substances in emergency situations.
Originally scheduled for January 1, 2020, the EU Commission has now agreed to delay the initial deadline for compliance with the amended CLP regulations by one year, to January 1, 2021. But, according to Dr. Charlotte Blackburn, a UL regulatory specialist based in Nottingham, U.K., many companies are still unaware of their obligations under the updated requirements.
“Under the CLP regulations, importers and ‘downstream users’ are required to submit information on hazardous mixtures for each product that they place on the EU market,” Blackburn noted. “This requirement may also apply to rebranded products supplied by a distributor if they are aware that the original supplier of the mixture hasn’t submitted a notification that covers their product. Some parties may want to consider filing a voluntary notification in cases where their non-hazardous mixture is incorporated into another party’s product.”
There are also potential issues with existing mixtures, according to Rusu.
“Importers and downstream users with notified mixtures currently on the market that fall under the scope of the EU’s CLP requirements have until January 1, 2025 to comply with the revised requirements,” she affirmed. “But if any aspect of the mixture related to its composition, classification, or toxicological properties changes during the transition period, parties are required to submit a notification for the modified product in accordance with the updated requirements.”
“Even with the one-year delay in the implementation of the revised requirements, most downstream users and importers have a lot of work to do,” Blackburn and Rusu said. “We’re encouraging our clients to proactively address these issues now, while there is still time to get it right.”