Regulation (EC) 1272/2008, commonly known as CLP Regulation, states in Article 45 that companies placing dangerous mixtures on the market must provide relevant information to national appointed bodies, so Poison Centres have available information to adequately advise consumers and medical personnel in case an emergency occurs.

Some finished products, like cosmetics, medical devices, veterinary medicinal products or medicinal products, are exempt from compliance with CLP only in their finished state intended for the final user.

Regulation 2017/542, an amendment to CLP Regulation, establishes the harmonised requirements for notification and sets the following compliance dates for companies:

• January 1^st 2021 is the compliance date for downstream users and importers to submit information on mixtures placed on the market, classified under CLP regulation and intended for consumer or professional use.
• January 1^st 2024 is the compliance date for downstream users and importers to submit information on mixtures placed on the market, classified under CLP regulation, and intended for industrial use.

Downstream user is a definition that commonly causes confusion given that, as per CLP definitions, manufacturers of mixtures, re-fillers, producers of articles and, end users fall into this category.

Our team of experts can advise and help your company with product compliance, preparing and submitting a PCN dossier for each country in which your product will be placed on the market.