1. Notification procedures
  2. Contained use GMOs/pathogens
  3. Supporting tools
  4. Contained use - Revision of the classification of formaldehyde

Contained use - Revision of the classification of formaldehyde

In 2014, the classification of formaldehyde has been revised. Formaldehyde was reclassified as a Carcinogen category 1B “presumed human carcinogen” and germ cell mutagen category 2 (ECHA, European Chemical Agency) whereas before it was classified as a Carcinogen category 2 and was not classified for germ cell mutagenic effect. 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, allowing suppliers to adapt the new classification.

Since 1 January 2016, this revised classification (including the changes for acute toxicity) as well as the labelling of chemical substances should be applied to free formaldehyde and mixtures containing formaldehyde from a threshold of 0.1% for its carcinogenic effect (Category 1B) and 1% for its germ cell mutagenic effect (Category 2) (European regulation n° 2015/491).

Formaldehyde is commonly used in R&D laboratories as disinfection agent for fumigation. Chemical products used for this application are defined as “biocidal products (biocides)” according to European Directive 98/8/EC. Since 1 September 2013, the implementation of this Directive is subjected to European Regulation No 528/2012. Among the 22 product types (PTs) of the biocidal products described in Directive 98/8/EC, biocidal products used for fumigation belong to PT2 (Disinfectants and algaecides not intended for direct application to humans or animals) or PT3 (Veterinary hygiene, products used to disinfect the materials and surfaces associated with the housing or transportation of animals).

This new classification has the following consequences:

  • The authorization of formaldehyde as biocidal product is being questioned by the European Chemical Agency. A substance classified as Carcinogen 1B is candidate for substitution. A public consultation was held and has been finalised in April 2015. The Biocidal products committee (BPC) opinion on the approval of the active substance formaldehyde in PT3 was adopted on 10 December 2015 and is available at the following link : http://echa.europa.eu/documents/10162/cf7067c7-2359-4a5f-883c-b16d240f963b

  • This new classification also has a consequence for the sale of the product to the general public. According to Annex XVII of Regulation (EC) 1907/2006, it is forbidden to supply to the general public subtsances that are classified as carcinogen category 1A or 1B, or mixtures containing these substances in a concentration greater than or equal to 0.1%.

  • The use of class A biocidal products (Carcinogen 1A and 1B are included in class A) requires an online registration system for their sale and use. However, two types of derogation for their use by approved users are specified in Article 56 of the Royal Decree (RD) of 22 May 2013 concerning the placing on the market and the use of biocides. Class A biocidal products may be used by professional users within their company. The list of the types of business to which this derogation applies is set out in the Ministerial Decree of 13 December 2010. Research and analysis laboratories in the medical and veterinary fields are included in this list.
  • This new classification has also a consequence on the workers. Indeed, the RD of 2 December 1993 modified by the RD of 9 November 2003 and the RD of 20 July 2015 concerning the protection of workers against the risks related to the exposure to carcinogens or mutagens at work provides for a series of measures, which are provided on the website of Federal Public Service Employment, Labour and Social Dialogue.

References:

  1. Regulation (EU) No 2015/491 amending regulation (EU) No 605/2014, amending regulation (EC) No 1272/2008 of the European Parliament and of the council of the 16 December 2008 on classification, labelling and packaging of substances and mixtures (Annex VI).
  2. Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.
  3. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
  4. Royal Decree of 22 May 2003 concerning the placing on the market and the use of biocidal products.
  5. Royal Decree of 8 May 2014 concerning the placing on the market and the use of biocidal products.
  6. Ministerial Decreeestablishing the list oftypes of companiesprovided for in Article56§ 2of the Royal Decreeof 22 May 2003concerning the placing onthemarket and useof biocidal products(M. B. 27.12.2010)
  7. Royal Decree of 2 December 1993 concerning the protection of workers against the risk of exposure to carcinogens and mutagens at work
  8. Royal Decree of 9 November 2003 modifying the Royal Decree of 2 December 1993 concerning the protection of workers against the risk of exposure to carcinogens and mutagens at work
  9. Royal Decree amendingvarious provisionsin order toadapt them to RegulationNo 1272/2008on classification, labeling and packaging of substancesand mixtures
  10. Regulation (EC) N0 1907/2006 on the registration, evaluation, authorisation and restriction of chemicals (REACH) and setting up a European Chemicals Agency