EU Regulatory Update: CLP Deadlines and Consequences

By: Annelie Struessman, PhD, CONUSBAT

Posted: March 3, 2010

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The notification deadline will be one month after Dec. 1, 2010. Since Jan. 1-2, 2011, fall on a weekend, the deadline for notification to the C&L Inventory is Jan. 3, 2011. For substances placed on the market after December 2010, the one-month period must be calculated from the first time they are placed on the market. If new information on a substance property becomes available that leads to a revision of the classification and labeling elements, the notification and the relevant registration dossier also must be updated. The notification to the C&L Inventory requires information on the identity of the substance, the CLP classification, and where applicable, information on the data basis for the performance of the classification. A notification dossier can either be created online using the REACH-IT tool or in the International Uniform Chemical Information Database (IUCLID), which is also submitted via REACH-IT.

In the C&L Inventory, the names of hazardous substances will be disclosed in International Union of Pure and Applied Chemistry (IUPAC) nomenclature and their classification and labeling according to the notifier’s respective registrant information. ECHA will add information on the type of classification, which may result from a joint registration under REACH and be harmonized at a community level. It is also possible that the classification was previously agreed upon by two or more companies, or that it was an individual classification. If the C&L Inventory discloses different classifications for the same substance, the notifiers or registrants must make every effort to agree upon their entry; however, varying impurity profiles of the same substance will not allow for an agreement. The disclosure of the IUPAC name may be withheld, e.g., for non-phase-in substances, if it can be justified to ECHA that the publication could be harmful to commercial interests.

The roles with responsibility under CLP are identical to those under REACH, and as such, various obligations apply to cosmetic manufacturers and suppliers. An EU manufacturer or an importer of ingredients needs to comply with all provisions of CLP, fulfilling all classification and notification steps. The role of an Only Representative is not defined in CLP. The cosmetic manufacturer or a re-importer of ingredients of a cosmetic product has the role of a downstream user (DU). DUs can assume the classification from their suppliers; however, they must classify their mixtures.

On Jan. 11, 2010, Regulation (EC) 1223/2009 on Cosmetic Products replaced the Cosmetics Directive 76/768/EEC and own legislation, i.e., that applied specifically to cosmetic products. Transitional periods are effective and the majority of provisions will be applicable beginning on July 11, 2013. Similar to the old Cosmetics Directive, the Cosmetics Regulation defines its own rules for product labeling, which are different than CLP labeling rules. Therefore, cosmetic products, i.e. mixtures in the finished state intended for the final user, are excluded from the scope of CLP. Also, any information on dangerous substances contained in cosmetic products must be easily accessible to the public and to the competent authorities, according to the provisions of the Cosmetics Regulation (Article 21).

One CLP provision that affects the use of substances for cosmetic products is the change in classification categories for carcinogenic, mutagenic or toxic for reproduction (CMR) substances, which took place with the change in cosmetics legislation. The Cosmetics Regulation refers to the new CMR categories 1A or 1B of CLP. The respective deadline from the Cosmetics Regulation for the provisions on use of CMRs in cosmetic products will be Dec. 1, 2010.