EU Regulatory Update: CLP Deadlines and Consequences

Mar 3, 2010 | Contact Author | By: Annelie Struessman, PhD, CONUSBAT
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Title: EU Regulatory Update: CLP Deadlines and Consequences
  • Article

The European Union’s adaptation of the Globally Harmonized System (GHS) is Regulation (EC) No. 1272/2008 on the classification, labeling and packaging (CLP) of substances and mixtures, which entered into force on Jan. 20, 2009. On Dec. 1, 2010, CLP will apply to substances and replace the Dangerous Substances Directive (DSD) (DSD/67/548/EEC), whereas the Dangerous Preparations Directives (DPD/1999/45/EC) will be affected only as of June 1, 2015, at which point both frameworks will be repealed.

The Dec. 1, 2010, deadline requires manufacturers and importers to classify, label and package substances according to CLP before placing them on the market. Also affected are: the REACH-defined substance classes (REACH Articles 6, 9, 17 and 18) that are not directly marketed; monomers; on-site isolated intermediates; transported intermediates; and substances used for product and process-orientated research and development (PPORD). The classification is part of all registration or notification information required under REACH. Registrations submitted before Dec. 1, 2010, should contain the classification and labeling according to the DSD. However, it is recommended to include CLP classification and labeling.

In preparation for a publicly accessible Classification and Labeling Inventory, CLP has its own notification provisions (CLP Article 40), which also will be effective on Dec. 1, 2010. When the CLP classification is provided in the REACH registration dossier, an additional CLP notification is not necessary. All other manufacturers or importers of substances must provide a notification to the European Chemicals Agency (ECHA) according to CLP Article 39 for the following substances:

1) Substances classified as hazardous under CLP imported or manufactured and placed on the EU market, either individually or included in a mixture above the legally defined concentration limits and irrespective of the tonnage. In other words, the requirement for notification goes beyond substances manufactured or imported in quantities of 1 tonne or more per year. Also included are polymers that fulfill the criteria for classification as hazardous and that are placed on the market; and

2) Substances subject to registration under REACH (≥ 1 tonne/year) that are not yet registered but have been placed on the market.

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.

Key Summary
• A Classification and Labeling Inventory will be created by ECHA and will be made publicly accessible.
• Manufacturers and importers of substances will have to all substances classified as hazardous and all substances placed on the EU markets, which are subject to registration by Jan. 3, 2011.
• Classification and labeling of substances, according to CLP, applies on Dec. 1, 2010.
• Manufacturers and importers of cosmetic ingredients will have to fully comply with CLP classification and notification provisions.
• For labeling of cosmetic products and for information on hazardous substances contained, cosmetic manufacturers will have to comply with the Cosmetics Regulation.
• CLP defines new CMR categories and affects the use of CMR substances in cosmetic products on Dec. 1, 2020.