European Chemical Regulations supplemented by national and local regulations apply to High Temperature Insulation Wools as these are considered chemical substances.
ECFIA has been collaborating with different European and national authorities to find appropriate solutions for the implementation of these regulations.
Overview of relevant regulations, guidelines and other references
Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) requires manufacturers, importers and Only Representatives of non-European manufacturers to share data on potential health and environmental hazards and provide those data to the European Chemicals Agency (ECHA) in a formalized registration process.
ECFIA members registered ASW/RCF (CAS N° 142844-00-6), AES (CAS N° 436083-99-7) and PCW (CAS N° 6575106-31-7) before the first deadline of 1 December 2010 and continue to register new fibre chemistries where necessary; these materials can therefore be used on the European market.
Classification and Labelling
Classification and labelling obligations were first imposed by EEC Directive 67/548 of 27 June 1967 (Dangerous Substances Directive) and its subsequent 31 adaptations to technical progress, in particular Directive 97/69/EC of 5 December 1997 relating to classification of man-made vitreous (silicate) fibres.
EC Regulation No 1272/2008 of 16 December 2008 (CLP) on classification, labelling and packaging of substances and mixtures, as amended from time to time, has now replaced both the Dangerous Substances Directive and the Dangerous Preparations Directive with the directives fully repealed on 1st June 2015.
The harmonized classifications listed within the Dangerous Substances Directive have been translated into the new system which adopted the UN Globally Harmonised System (GHS) nomenclature and symbols. Although the classification itself is not altered, labels, pictograms, signal words, hazard communication and precautionary statements have been changed.
EU hazard categories for carcinogens
- Category 1: „Known or presumed human carcinogens“
- Category 1A: „Known to have carcinogenic potential for humans, classification is largely based on human evidence“ e.g. asbestos
- Category 1B: „Presumed to have carcinogenic potential for humans, classification is largely based on animal evidence“
- Category 2: „Suspected human carcinogens. The placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B.“
Alumino Silicate Wool (ASW)
ASW, also known as refractory ceramic fibre (RCF), have a harmonised classification under CLP Regulation of carcinogen category 1B „Presumed to have carcinogenic potential for humans, classification is largely based on animal evidence“.
ASW is listed under EU index number 650-017-00-8 in Annex VI part 3 table 3.1 of CLP which specifies the information required on the labels.
Special labelling obligations exist for ASW/RCF substances and for mixtures if they contain 0.1% by weight of the substance.
may cause cancer by inhalation
Low Biopersistent Wool (LBP)
Low Biopersistent Wools (LBP), including, Alkaline Earth Silicate (AES) and Alkali Metal Silicate (AMS) wools produced by ECFIA members have been exempted from classification after scientific assessment. They fulfil the Exoneration Criteria of Note Q of CLP Regulation based on biopersistence tests or long-term animal studies. (See Annex VI part 3 table 3.1 of CLP, EU index number 650-016-00-2.)
Labelling is not required under CLP.
PCW are not classified under CLP and labelling is not required.
In Germany, TRGS documents provide technical guidance on worker protection. TRGS 905 considers some inorganic fibrous work place dust as carcinogenic, mutagenic or toxic for reproduction. Fibrous dusts emanating from the handling of polycrystalline wools are classified as Category K2: “ … cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment … “ Although the TRGSs are not laws they are technical rules/recommendations with a quasi-legal status.
Candidate List of ASW/RCF
Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B may be identified as Substances of Very High Concern (SVHCs) meaning that such a substance is a candidate for authorization.
On December 19th 2011, Zirconia Aluminosilicate Refractory Ceramic Fibres and Aluminosilicate Refractory Ceramic Fibres, both covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of the CLP Regulation, were included in the Candidate List.
Notification and communication obligations set out in articles 7 and 33 of REACH apply to companies selling and/or using substances, mixtures or articles containing these substances; however notification is only required if the use is not already covered by uses mentioned in the registration.
In 2013 the ECHA included Zirconia Aluminosilicate Refractory Ceramic Fibres and Aluminosilicate Refractory Ceramic Fibres, in their 5th recommendation for authorisation, after extensive analysis the EC and European Parliament decided in 2016 not to include these substances on the authorisation list at this time. They remain on the SVHC candidate list and obligations mentioned above must still be meet.
ASW/RCF may be used on the European market by respecting the above-mentioned obligations and those resulting from the Carcinogens Directive and Health and Safety Regulations.
ECFIA has cooperated with regulators, scientists and other European industry associations to communicate general information and expert knowledge in the field of occupational health and safety in relation to HTIW. An archive of this information can be found in the download section under Position Papers.