The CLP (Harmonised Classification, Labelling and Packaging) Regulation for substances and mixtures (1272/2008/EC) harmonises the hazard classification and labelling of chemical substances and mixtures in the European Union and the European Economic Area. CLP entered into force on 20 January 2009. The deadline for substance classification under CLP was 1 December 2010. On 1 June 2015 the new CLP Regulation will replace the previous classification rules under the Dangerous Substances Directive (Directive 67/548/EEC and the Dangerous Preparations Directive (1999/45/EC). CLP aligns the European Union with the Globally Harmonised System (GHS) for the classification and labelling of substances. The GHS is a global initiative to:
- Define health, physical and environmental hazards of chemicals;
- Create classification processes that use available data on chemicals for comparison with the defined hazard criteria; and
- Communicate hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS)
CLP only assesses the hazardous properties of chemical substances, based on available scientific data, to establish hazard classifications. The legislation is not intended to evaluate whether a hazardous substance poses an actual risk to humans. Under the CLP, a Member State, or the European Chemical Agency (ECHA) upon request of the European Commission, may submit a dossier for the harmonised classification and labelling (Harmonised C&L) of a substance.
Formaldehyde and CLP
Formaldehyde is one of the most thoroughly evaluated substances. In 2014 Formaldehyde was reclassified as a Carcinogen Category 1B. According to the CLP Regulation, Category 1B substances are presumed to have carcinogenic potential for humans and classification is largely based on animal evidence as opposed to substances falling under Category 1A. The new classification entered into force in June 2014 when published in the Official Journal of the European Union. However, authorities have foreseen a transition period until 1 January 2016, allowing suppliers to adapt to the new classification. The commission decision confirming this can be found in Commission Regulation 2015/491. After 1 January 2016 the new Classification and Labelling rules must be applied to substances containing 0.1% free formaldehyde or above.
Formacare recommends that free formaldehyde in liquid adhesives should be performed in accordance with EN 1243:2011. The recommendation is valid only for aminoplast resins (for example wood glues and impregnating resins) containing formaldehyde, and/or urea and/or melamine, but excluding etherified adhesives. The best practice recommendations can be found here.
Background and rationale
When evaluating the carcinogenicity of substances, European regulators take into account evidence from studies on both animals and humans. Since 1980 there have been over 100 studies investigating the potential link between formaldehyde and cancer. On 28 September 2011, France submitted a dossier to ECHA for the reclassification and labelling of formaldehyde as Category 1A ‘substances known to have carcinogenic potential’. There was then a 45 day public consultation that began in October 2011. On behalf of the formaldehyde industry, formacare submitted a contribution to the public consultation on the scientific merits of France’s proposal for harmonised C&L. After the public consultation, the rapporteur appointed on behalf of the Risk Assessment Committee (RAC) of ECHA, Germany, began the review of the formaldehyde dossier. On 7 December 2012 ECHA announced the adoption of a scientific opinion of the RAC to reclassify formaldehyde as carcinogen 1B “presumed human carcinogen” and germ cell mutagen category 2. In reaching their opinion the RAC found that the science relating to human exposure could not support France’s proposal to classify formaldehyde as carcinogen category 1A, and they instead agreed that category 1B was warranted. The proposed classification is based on nasopharyngeal cancer, an extremely rare form of cancer in Europe. On 20 December 2013 the EU REACH Committee adopted a decision to reclassify formaldehyde as a category 1B carcinogen. This decision was implemented through the 6th Adaptation to Technical Progress (ATP) to the CLP Regulation published in the Official Journal of the European Union on 6 June 2014. On November 25 2014, the EU REACH Committee agreed via written procedure to postpone the deadline for the transition period until 1 January 2016. On March 23 2015, the decision was formally confirmed with the publication of the Commission Regulation 2015/491. Industry has therefore until 1 January 2016 to comply with the new classification.