Comments from EU relating to Draft Technical regulation on safety of chemicals.
It is not clear to the EU what is meant in Article 7, paragraph 1 by "the name of the document in accordance with which chemical products have been manufactured (when available)" and why this would have to be indicated on the label. Could the Russian authorities provide some examples? It is not clear that the labelling requirements concur fully with the GHS rules, in particular the various elements such as pictograms, signal word, hazard and precautionary
statements. Are these all contained in GOST standard 31340 which is referred to in paragraph 5 of Article 7 and in Article 8?
Notification of neww chenical substances.
This article establishes the rules for notification of new chemical substances and/or new chemical products of variable composition to the Register of Chemical Substances and Chemical Products. However, many details are missing and certain requirements are unclear. Therefore, the EU would appreciate further clarification on the following questions. What are the tonnage triggers that require notification of a substance? Any quantity registration only when a substance is placed on the market in quantities above 1 ton/y ear/ma nuf act u re r (importer) and the amount of data to be provided depends on the overall quantity. Also, a chemical safety report has to be provided only for substances placed on the market in quantities higher than 10 tons per year and there are reduced requirements for substances used only as intermediates in industrial processes. Article 11, paragraph 2 is unclear: How can a manufacturer determine whether a substance (or product of variable composition) is new? The paragraph refers to the "new chemical substances ... which are released for circulation after coming into effect of the Regulationhowever there is no reference to a list of substances already released into circulation at that moment in time, which would be necessary to determine if a substance is new. Othen/vise, all substances would actually be new. Will the first version of the Register contain such a list of substances already notified? If so, how will this initial list be established? Who are the "Authorised Bodies" for notification and when will they be made known? Data requirements in Appendix 5 are unclear, in particular with regard to the tests which are required. Notably, the footnote in Appendix 5 on this matter is not clear at all "The scope of the required study (testing) ... is determined depending on the types of hazardous effects ... made by related (similar by the chemical composition) chemical compounds". Appendix 5 also requires an exposure assessment and exposure scenarios, which seem to be the same. There are no provisions with regard to reducing animal testing and re-using existing data, read-across, Quantitative Structure-Activity Relationships (QSAR) and other alternative methods, etc. What about possibilities for using data from existing data bases such as the REACH dissemination website or the OECD e-Chemportal? There are no periods of data protection specified. As a consequence, if one company notifies test data for a substance to the Register (which have been generated at potentially high costs), it seems possible that these could immediately be used by another company, which would have no costs to bear. It is, therefore, indispensable that the draft Regulation will establish appropriate periods of protection for proprietary data submitted to the Register by a comp any (e.g. 10 years) and during this time period they can only be used by another company with the agreement of the original owner (and against appropriate financial compensation). There are no provisions on confidentiality (i.e. information on the exact composition of substances or products of variable composition), and it is unclear whether public commenting or disclosure of "non-confidentiaľ information so that stakeholders could comment is or will be provided for.
As already mentioned earlier, the EU sees no need for "conformity assessment procedures" for each chemical product placed on the market in Russia - in particular not for non-hazardous chemical products. It should be the responsibility of the manufacturers/importers to comply with the legal requirements without having an approval process conducted by the authorities for every individual product. Registration/notification could be limited to substances (as in REACH) - and not be required for each mixture many of which will contain the same substances, which have already been notified. The EU would also like to recall that the number of mixtures placed on the market can be very high ( several millions in the EU) compared to the number of substances contained therein. More specifically, for the "accounting state registration" (Article 12, paragraph 5): for which quantity/volume is this required? Why is it necessary to present test data on mixtures? The GHS sets out explicitly that the hazard classification of mixtures can be calculated on the basis of the hazard classification of the substances contained therein to avoid unnecessary testing. Consequently, the exemption clause at the end of this paragraph should be made the universal rule. It is also not clear from this provision in the draft Regulation which test data would be required, whether laboratories conducting tests have to be GLP compliant, and whether data requirements are dependent on the tonnage of the chemical product placed on the market in Russia. For Article 12, paragraph 9, the same comments apply as for Article 12, paragraph 5: testing of mixtures should not be required. The time frame in Article 12, paragraph 6 for the authorities (20 business days) is much too short and does not allow for any meaningful evaluation of the data submitted, entering all the required data into the Register and issuing a certificate of registration. It is not clear against which criteria they will evaluate the completeness and accuracy of the information presented. What will happen if the competent bodies do not respect the deadlines? Is there any possibility to appeal or object against (negative) decisions? Among others, the authorities will enter information on the composition of all products into the Register of Chemical Substances and Chemical Products. This is, in fact, very sensitive information that should be kept confidential. Other provisions of the draft Regulation seem to suggest that the Register will be available for consultation by companies and the general public. How will the protection of confidential information be assured and which information will be recognised as confidential? The EU would like to underline once more that none of the procedures provides for public commenting or disclosure of "non-confidentiaľ information so that stakeholders could comment before the authorities take a decision. For Article 12, paragraph 11, the same comments apply as for Article 12, paragraph 6.