Regulation (EC) No 1907/2006 of the European Parliament and the Council 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.
For registration, manufacturers and importers of the same substance manufacturing or importing more than 1 metric ton per year needed to agree on:
REACH and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP) are based on the principle of self-classification by industry. The prior harmonized classification of substances contained in Annex VI of CLP (prior Annex 1 of Directive 67/548) has to be respected as a minimum classification; industry has to evaluate whether additional/stricter classification applies.
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.
On June 24th 2013, the European Chemicals Agency (ECHA) published its fifth draft recommendation for substances to be placed on the REACH authorisation list (Annex XIV), including Alumino-Silicate RCF and Zirconia-Alumino-Silicate RCF. A number of arguments were raised in the public consultation questioning the quality of information supporting ASW/RCF authorisation. Concerns were also raised by representatives in the Member States Committee meetings (see dissenting views by UK, Austria, Czech Republic and Hungary recorded in the minutes of the 33rd meeting of the Member States Committee (MSC). [Link to minutes]
Following consultation with the MSC on 6th February 2014, ECHA sent the 5th recommendation, including Alumino-Silicate RCF and Zirconia-Alumino-Silicate RCF, to the European Commission for final review and decision.
In January 2017 the European Commission published the result of a voting of the REACH Article 133 Committee which took place during a meeting on December 8th 2016. The group voted on the Commission proposal for the inclusion of another 12 substances on REACH Annex XIV (the Authorisation List) based on ECHA´s 5th and 6th recommendation. The Commission proposal was accepted by the vast majority: 25 Member States voted in support with only 3 abstentions.
For some substances included in ECHA´s recommendations the Commission has suggested to either postpone the inclusion on Annex XIV or to evaluate other regulatory options. ASW/RCF has been part of the group of substances which were not suggested to move forward to authorisation. In its justification the Commission stated that ASW/RCF fibres “are manufactured at a very limited number of industrial sites and are in general directly transformed […] into articles.” Articles are not subject to authorisation. Through their vote the Member States confirmed the Commission´s view that a further assessment of “the most relevant regulatory approach” is required. This decision is in line with ECFIA´s position.
ECFIA is of the opinion that the overall objective to ensure the management of health risks related to ASW/RCF can be better achieved via harmonized workplace controls, such as through the introduction of a Binding Occupational Exposure Limit Value (BOELV). [See industry position paper]
ASW/RCF not included on REACH Annex XIV
Specific information related to the potential inclusion of ASW in the REACH authorisation process.
The scope of this paper is to define the REACH object status of products based on HTIW at several stages of manufacturing and downstream use ...
ECFIA, along with 14 major industry associations, has developed a joint position paper on the advantages of the introduction of a BOELV under the existing framework of the CMD. The BOELV appears to be a much more efficient and effective way to achieve the overall objective of improved risk management, via harmonized workplace controls.