Hazardous substance classification of synthetic amorphous silica (SAS)
https://www.europarl.europa.eu/doceo/document/P-9-2021-001236_EN.html
3.3.2021
Priority question for written answer P-001236/2021
to the Commission
Rule 138
Dennis Radtke (PPE)
The Commission is planning to proceed with the hazardous substance classification of amorphous silica, and the current proposal of the Committee for Risk Assessment (RAC) is for synthetic amorphous silica (SAS) to be classified as a hazardous substance. This hasty decision appears to be incorrect and would have a significant impact on the companies and, not least of all, the employees concerned. A number of questions arise in this context.
- 1.Is the Commission aware of the fact that some of the studies consulted by the RAC are over 20 years old and that new evaluations of the studies cast doubt on their conclusions? Will the Commission wait for and take into account new, more detailed studies which are currently being prepared?
- 2.How does the Commission respond to the fact that the different kinds of SAS play an important role as long-established materials with extremely varied uses, including to increase resource efficiency and reduce CO2 emissions?
- 3.How does the Commission view the fact that non-material-specific (general) particle effects are no basis for classifying a material under the CLP Regulation (acute and repeated inhalation)? According to the CLP Regulation, only intrinsic properties of materials are relevant for the purposes of harmonised classification and labelling (CLH).
Answer given by Mr Sinkevičius on behalf of the European Commission
13.4.2021
The Committee for Risk Assessment (RAC) of the European Chemicals Agency concluded in December 2019 that classification of a specific form of synthetic amorphous silica (SAS)[1] for certain hazards[2] is appropriate.
The Commission currently consults the responsible Expert Group on the 18th adaptation to technical progress of Annex VI[3] of Regulation (EC) No 1272/2008 (CLP Regulation)[4], including i.a. SAS. Industry stakeholders can participate in the deliberations of the expert group. The Commission will take a decision on the classification after this consultation.
RAC evaluates a substance following a classification proposal by a Member State[5] and based on the information available at that time. RAC conclusions take into account solely scientific evidence on the hazard of a substance, mostly toxicological studies submitted under other relevant EU legislation[6].
In relation to this evidence, it should be noted that the age of a study is not the primary criterion to judge its value, as long as the quality and results are considered sufficiently scientifically robust to conclude on a classification.
Socioeconomic impacts are not considered in the classification process for specific substances and should be taken into account in the downstream legislation. CLP Regulation itself only concerns the classification, labelling and packaging of substances and mixtures, but does in no way restrict their use.
The CLP Regulation refers, as regards the hazards of substances or mixtures, to the form or physical state in which they are placed on the market or used. The Commission considers that hazards arising from a particular form or physical state of a substance (such as particles) are also intrinsic hazards of a substance.
- [1] Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide (EC: 272-6971; CAS: 68909-20-6).
- [2] The concerned hazard classes are Specific target organ toxicity, repeated exposure (STOT RE 2) and Acute toxicity (Acute Tox.2).
- [3] Annex VI of the CLP Regulation contains the list of substances with harmonised classification.
- [4] 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1‐1355.
- [5] Manufacturers, importers and downstream users may also submit a proposal for a harmonised classification and labelling of that substance under certain conditions.
- [6] E.g. Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 396, 30.12.2006; Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, OJ L 167, 27.6.2012, p. 1‐123, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, OJ L 309, 24.11.2009, p. 1‐50.
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