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Document 32018R1881
Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance.)
Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance.)
Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance.)
C/2018/7942
IO L 308, 4.12.2018, p. 1–20
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Relation | Act | Comment | Subdivision concerned | From | To |
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Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 1.3.1 mír 2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 1.3.2 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn I pointe 3.0.2 abairt | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 3.2.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 3.2.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 4.0.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 5.2.2 abairt | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I pointe 5.2.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 0.1 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn I foroinn 0.11.a | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 0.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 0.4 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 0.5 mír neamhuimhrithe | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 0.6.3 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn I foroinn 1.0.3 mír 1 FR | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 2.2 mír 2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 4.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn I foroinn 5.0 mír 1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn III | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn IX pointe 8.6.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn IX pointe 9.2.1.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn IX foroinn 9.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn IX foroinn 9.4 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn IX Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VI foroinn 2.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VI roinn 2 Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VI roinn 3 Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VI roinn 5 Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VI roinn 6 Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VI Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII pointe 8.4.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII pointe 8.5.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII pointe 9.1.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII pointe 9.1.2 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VII foroinn 7.14.a | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII foroinn 7.7 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VII foroinn 7.8 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VII Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII pointe 8.6.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII pointe 9.1.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII pointe 9.1.4 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII pointe 9.2.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII pointe 9.3.1 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII foroinn 8.5 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII foroinn 8.8 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn VIII foroinn 9.2 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VIII roinn 7 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn VIII Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn X pointe 8.6.3 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn X Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn XI pointe 1.1.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn XI foroinn 1.2 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn XI foroinn 1.3 | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn XI foroinn 1.4 mír | 01/01/2020 | |
Modifies | 32006R1907 | Athchur | iarscríbhinn XI foroinn 1.5 mír 1 | 01/01/2020 | |
Modifies | 32006R1907 | Cur le | iarscríbhinn XI Téacs | 01/01/2020 | |
Modifies | 32006R1907 | Leasú | iarscríbhinn XII | 01/01/2020 |
4.12.2018 |
EN |
Official Journal of the European Union |
L 308/1 |
COMMISSION REGULATION (EU) 2018/1881
of 3 December 2018
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 131 thereof,
Whereas:
(1) |
Regulation (EC) No 1907/2006 lays down specific registration duties and obligations on manufacturers, importers and downstream users to generate data on substances they manufacture, import or use to assess the risks related to these substances and to develop and recommend appropriate risk management measures. |
(2) |
The Commission Communication on the Second Regulatory Review on Nanomaterials (2) concluded that Regulation (EC) No 1907/2006 sets the best possible framework for the risk management of nanomaterials when they occur as forms of substances or mixtures but more specific requirements within the framework are necessary. |
(3) |
The Commission performed an impact assessment (3) and further concluded that it is necessary to clarify the registration duties and obligations for nanomaterials. The term nanoform should be defined for the purposes of Regulation (EC) No 1907/2006 on the basis of Commission Recommendation of 18 October 2011 on the definition of nanomaterial. |
(4) |
Nanoforms may have specific toxicological profiles and exposure patterns and may therefore require specific risk assessment and adequate sets of risk management measures. |
(5) |
Without the minimum standard information in the technical dossier and the chemical safety report specifically addressing nanoforms, it is not possible to ascertain whether the potential risks have been adequately assessed. Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in the Annexes I, III and VI to XII to Regulation (EC) No 1907/2006. This should ensure a clear and effective implementation with proportionate costs, guaranteeing a high level of protection of human health and the environment without adversely affecting innovation and competitiveness. The adopted changes for nanoforms should be without prejudice to the performance and documentation of risk assessment of other forms of the registered substance, unless it has implicitly included nanoforms in the assessment. |
(6) |
Manufacturers and importers should assess and where relevant, generate the necessary information and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report. A use may modify the nanoforms of the substance, potentially changing one nanoform into another form or generating a new nanoform. Downstream users should provide this information up the supply chain to ensure that the use is adequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report. |
(7) |
As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms. The existing qualitative or quantitative structure-activity relationship (QSAR) and other tools do not yet enable prioritisation; therefore, the insolubility information should be applied as a surrogate for potential toxicological and ecotoxicological aspects for the nanoforms of a substance. |
(8) |
For nanoforms, specific minimum characterisation information should be provided as part of the composition information under the substance identification. Particle size, shape and surface properties of a nanoform may influence its toxicological or ecotoxicological profile, exposure as well as behaviour in the environment. |
(9) |
For reasons of workability and proportionality, it should be possible to group nanoforms with similar characteristics in sets of similar nanoforms. The characterisers of the different nanoforms within sets of similar nanoforms should be provided in ranges of values that clearly define the boundaries of the set of similar nanoforms. When set of similar nanoform is defined, a justification should be provided that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the individual nanoforms within the set of similar nanoforms. |
(10) |
All different nanoforms covered by the registration should be considered by the registrant in the demonstration of safety. Similarly, the information on manufacture, uses of and exposure to the different nanoforms should be provided separately to demonstrate their safe use. Where defined, a set of similar nanoforms may be used to document this information jointly for the nanoforms within the set. |
(11) |
Nanoforms or sets of nanoforms, where defined, should be identified in the joint submission using the same nanoform characterisation principles and should provide the link between the nanoforms identified in the individual registrations and the relevant information in the joint submission. |
(12) |
To allow for adequate assessment of the relevance of any physicochemical, toxicological and ecotoxicological information for the different nanoforms, the test material should be appropriately characterised. For the same reasons, test conditions documented and a scientific justification for the relevance and adequacy of the utilised test material as well as documentation for the relevance and adequacy of the information obtained from means other than testing for the different nanoforms should be provided. |
(13) |
The rate of dissolution in water as well as in relevant biological and environmental media should always be considered for nanoforms as it represents important complementary information to water solubility as a basic physico-chemical property of nanoforms that may determine the approach to their risk assessment and testing. |
(14) |
The partition coefficient in octanol-water is generally used as a proxy for adsorption or accumulation but may often not be applicable to nanoforms. In those cases, the study of dispersion stability in the different relevant test media that significantly influences these endpoints as well as any estimations of exposure to nanoforms, should be considered instead. |
(15) |
Certain physico-chemical properties such as water solubility or partition coefficient in octanol-water serve as input to well established QSARs and other predictive models that can be used for adaptations of some of the information requirements. As the underlying assumptions may not always apply to nanomaterials, such adaptations should be used for nanoforms only with scientific justification. In specific cases, the dissolution rate in the relevant test media may be used instead. |
(16) |
To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms. |
(17) |
The specific properties of the nanoform may sometimes prevent their uptake through the cell wall of bacteria, rendering the in vitro gene mutation study in bacteria (the AMES test B.13-14, OECD TG 471) inappropriate. To ensure that the tiered strategy for mutagenicity can still be implemented also in such cases, one or more other in vitro mutagenicity study(ies) in mammalian cells or other internationally recognised in vitro methods should be provided in such cases also for low-volume substances. |
(18) |
Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation is considered as more appropriate route of exposure and should be required instead, unless the exposure to humans is unlikely. |
(19) |
For the generation of information on short term repeated dose and sub-chronic toxicity via inhalation route, testing of a nanoform should always include histopathological determination of brain, lung tissues as well as examination of bronchoalveolar lavage (BAL) fluid, kinetics and an appropriate recovery period, in line with the OECD technical guidance. |
(20) |
Unless the nanoform dissolves fast once entering the organism, the distribution of a nanoform in the body may affect the toxicological profile when compared to other forms of the same substance. Therefore, an assessment of the toxicokinetic behaviour should be available for the chemicals safety assessment of a nanoform, when such assessment is required. This should allow the development of effective testing strategy or its adaptation for the substance with nanoforms with the aim of minimising animal testing. Where relevant, a study complementing the compilation of existing toxicokinetic information should be proposed by the registrant or may be requested by the European Chemicals Agency (the Agency) in accordance with Article 40 or 41 of the Regulation (EC) No 1907/2006. |
(21) |
A number of specific physico-chemical properties in addition to those used to identify the different nanoforms may be considered relevant for scientific understanding of the hazard and exposure of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for substances (including any nanoforms) that are placed on the market in higher volumes than 10 tonnes/year should be required to explicitly consider such further information in case other particle properties significantly influence hazard or exposure to those nanoforms. |
(22) |
The adaptation of the standard testing requirements in Annexes VII to X to Regulation (EC) No 1907/2006 applying general rules for adaptation under Section 1 of Annex XI should address different nanoforms separately. For grouping of different nanoforms, the molecular structural similarity alone cannot serve as justification for the application of read-across or grouping. |
(23) |
The Agency, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006. |
(24) |
Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 should therefore be amended accordingly. |
(25) |
Compliance with the provisions of this Regulation should not be required immediately in order to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. However, it should be possible for registrants to comply with those provisions already before the date of application. |
(26) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 are amended in accordance with the Annex to this Regulation.
Article 2
By way of derogation from the second paragraph of Article 3, manufacturers and importers registering substances with nanoforms either as non-phase-in or phase-in substances pursuant to Article 5 of Regulation (EC) No 1907/2006 as well as downstream users generating chemical safety reports may comply with this Regulation before 1 January 2020.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 December 2018.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 396, 30.12.2006, p. 1.
(2) COM(2012) 572 final.
(3) Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials [SWD(2018)474].
ANNEX
1.
Annex I to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
Subsection 0.1. is replaced by the following:
|
(b) |
Subsection 0.3. is replaced by the following:
|
(c) |
Subsection 0.4. is replaced by the following:
|
(d) |
The last paragraph in subsection 0.5. is replaced by the following: ‘If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration.’; |
(e) |
Point 0.6.3 is replaced by the following:
|
(f) |
After subsection 0.11. the following subsection 0.11.bis is added:
|
(g) |
The following sentence is added after the first paragraph of section 1.0.3: ‘The assessment shall address all nanoforms that are covered by the registration.’; |
(h) |
The second paragraph of point 1.3.1. is replaced by the following: ‘The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.’; |
(i) |
Point 1.3.2. is replaced by the following:
|
(j) |
The second paragraph of subsection 2.2. is replaced by the following: ‘If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.’; |
(k) |
The following sentence is added at the end of point 3.0.2.: ‘The assessment shall address all nanoforms that are covered by the registration.’; |
(l) |
Point 3.2.1. is replaced by the following:
|
(m) |
Point 3.2.2. is replaced by the following:
|
(n) |
Point 4.0.2. is replaced by the following:
|
(o) |
Subsection 4.2. is replaced by the following:
|
(p) |
The first paragraph of subsection 5.0. is replaced by the following: ‘The objective of the exposure assessment shall be to make a quantitative and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The assessment shall address all nanoforms that are covered by the registration. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:’; |
(q) |
The following sentence is added at the end of point 5.2.2.: ‘When nanoforms are covered by the registration, the emission estimation for these shall, where relevant, take account of situations when the conditions outlined in Annex XI section 3.2 point (c) are fulfilled.’; |
(r) |
Point 5.2.3. is replaced by the following:
|
2.
Annex III to Regulation (EC) No 1907/2006 is replaced by the following:‘CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
Criteria for substances and, when applicable, for nanoforms thereof, registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):
(a) |
substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII; |
(b) |
substances:
|
3.
Annex VI to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
The subtitle and the introductory text under the current subtitle ‘Guidance note on fulfilling the requirements of annexes VI to XI’ are replaced by the following: ‘NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use, and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care. A substance is defined in accordance with Article 3(1) and identified in accordance with section 2 in this Annex. A substance is always manufactured or imported in at least one form. A substance can also occur in more than one form. For all nanoforms covered by the registration certain specific information items shall be provided. Nanoforms shall be characterised as provided for in this Annex. The registrant shall justify why the information provided in the joint registration, covering the information requirements for the registered substances with nanoforms, is adequate for assessing the nanoforms. Information relevant to cover information requirements for such a substance can also be submitted separately by individual registrants, where justified in accordance with Article 11(3). More than one dataset may be required for one or more information requirements whenever there are significant differences in the properties relevant for the hazard, exposure and risk assessment and management of nanoforms. The information shall be reported in such a manner that it is clear which information in the joint submission pertains to which nanoform of the substance. Where technically and scientifically justified, the methodologies set out in Annex XI.1.5 shall be used within a registration dossier when two or more forms of a substance are “grouped” for the purposes of one, more or possibly all the information requirements. The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance. Definition of a nanoform and a set of similar nanoforms:
|
(b) |
Step 1 is replaced by the following: ‘STEP 1 — GATHER AND SHARE EXISTING INFORMATION The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance. Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance including on all nanoforms of the substance that are covered by the registration, regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests. In addition, information on exposure, use and risk management measures in accordance with article 10 and this Annex should be collected. Considering all this information together, the registrant will be able to determine the need to generate further information.’; |
(c) |
Step 3 is replaced by the following: ‘STEP 3 — IDENTIFY INFORMATION GAPS The registrant shall then compare the information needs for the substance with the information already available and the extent to which currently available information can be applied to all nanoforms covered by the registration and identify where there are gaps. It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.’; |
(d) |
Step 4 is replaced by the following: ‘STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted. The above approach shall also apply if there is a gap of available information for one or more nanoforms of the substance included in the jointly submitted registration dossier. In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements. NOTES Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions. Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justification.’; |
(e) |
The introductory text in Section 2 Identification of the substance is replaced by the following: ‘For each substance, the information given in this section shall be sufficient to enable each substance to be identified and the different nanoforms to be characterised. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.’; |
(f) |
Subsection 2.3. is replaced by the following: 2.3. Composition of each substance. Where a registration covers one or more nanoforms, these nanoforms shall be characterised pursuant to section 2.4 of this Annex. 2.3.1. Degree of purity (%) 2.3.2. Nature of impurities, including isomers and by-products 2.3.3. Percentage of (significant) main impurities 2.3.4. Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors) 2.3.5. Spectral data (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum) 2.3.6. High-pressure liquid chromatogram, gas chromatogram 2.3.7. Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced. 2.4. Characterisation of nanoforms of a substance: For each of the characterisation parameters, the information provided may be applicable to either an individual nanoform or a set of similar nanoforms provided that the boundaries of the set are clearly specified. The information in points 2.4.2 – 2.4.5 shall be clearly assigned to the different nanoforms or sets of similar nanoforms identified in point 2.4.1. 2.4.1. Names or other identifiers of the nanoforms or sets of similar nanoforms of the substance 2.4.2. Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm. 2.4.3. Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number. 2.4.4. Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate 2.4.5. Surface area (specific surface area by volume, specific surface area by mass or both) 2.4.6. Description of the analytical methods or the appropriate bibliographical references for the information elements in this sub-section. This information shall be sufficient to allow the methods to be reproduced.’; |
(g) |
In section 3, the following introductory text is added after the title ‘INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)’: ‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information on manufacture and use under 3.1-3.7 shall include separate information on the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4.’; |
(h) |
In section 5, the introductory text is replaced by the following: ‘This information shall be consistent with that in the Safety Data Sheet where such a Safety Data Sheet is required according to Article 31. Where a substance being registered is also manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 where relevant.’; |
(i) |
In section 6, the following introductory text is added after the title ‘INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFACTURER OR IMPORTER’: ‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 separately.’ |
4.
Annex VII to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
In the introductory text, the following text is added after the third paragraph: ‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’; |
(b) |
Subsection 7.7 is replaced by the following:
|
(c) |
Subsection 7.8 is replaced by the following:
|
(d) |
After subsection 7.14., the following is added:
|
(e) |
Point 8.4.1. is replaced by the following:
|
(f) |
Point 8.5.1 is replaced by the following:
|
(g) |
Point 9.1.1. is replaced by the following:
|
(h) |
Point 9.1.2. is replaced by the following:
|
5.
Annex VIII to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
In the introductory text, the following text is added after the first paragraph: ‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’; |
(b) |
A new section is inserted: ‘7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE
|
(c) |
Subsection 8.5. is replaced by the following:
|
(d) |
Point 8.6.1 is replaced by the following:
|
(e) |
Subsection 8.8. is replaced by the following:
|
(f) |
Point 9.1.3 is replaced by the following:
|
(g) |
Point 9.1.4. is replaced by the following:
|
(h) |
Subsection 9.2. is replaced by the following:
|
(i) |
Section 9.2.2 is replaced by the following:
|
(j) |
Point 9.3.1. is replaced by the following:
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6.
Annex IX to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
In the introductory text, the following text is added after the second paragraph: ‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’; |
(b) |
Point 8.6.2 is replaced by the following:
|
(c) |
Point 9.2.1.2. is replaced by the following:
|
(d) |
Subsection 9.3. is replaced by the following:
|
(e) |
Subsection 9.4 is replaced by the following:
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7.
Annex X to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
In the introductory text, the following text is added after the second paragraph: ‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’; |
(b) |
Point 8.6.3. is replaced by the following:
|
8.
Annex XI to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
In the introductory text, the following text is added after the last paragraph: ‘The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.’; |
(b) |
Point 1.1.3. is replaced by the following: ‘1.1.3. Historical human data Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered. The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:
In all cases adequate and reliable documentation shall be provided. When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’; |
(c) |
Subsection 1.2. is replaced by the following: ‘1.2. Weight of evidence There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion. There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property. Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
In all cases adequate and reliable documentation shall be provided. When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’; |
(d) |
Subsection 1.3. is replaced by the following: ‘1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR) Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:
The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples. When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’; |
(e) |
The last paragraph in Section 1.4 is replaced by the following: ‘Such confirmation may be waived if the following conditions are met:
When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.’; |
(f) |
The first paragraph in Section 1.5 is replaced by the following: ‘Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint. The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances. When nanoforms are covered by the registration the above approach shall address the nanoforms separately. For grouping different nanoforms of the same substance the molecular structural similarities alone cannot serve as a justification. If nanoforms covered by a registration are grouped or placed in a “category” with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner.’ |
9.
Annex XII to Regulation (EC) No 1907/2006 is amended as follows:
(a) |
The introductory text is replaced by the following: ‘INTRODUCTION The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a mixture or in an article. The assessment shall address all nanoforms that are covered by the registration. Justifications and conclusions drawn from the assessment shall be relevant to the nanoforms, from their receipt by the downstream user, for his own uses and for his identified uses further down the supply chain. In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation. When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, an appropriate metric for the assessment and presentation of the results in steps 1- 6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation is preferable, ensuring availability of mass metric information. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account. The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps:’; |
(b) |
Under Step 2, the following text is added after the first paragraph: ‘When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, the assessment shall cover the hazard, PBT and vPvB assessment of nanoforms(s) as used.’; |
(c) |
Under Step 2, the third paragraph is replaced by the following: ‘In those cases where the downstream user considers that information, in addition to that provided by the supplier, is necessary for producing his Chemical Safety Report, the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting for results of further testing, he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that he has put in place. The above record taking shall address all nanoforms that are covered by his own uses or his identified uses down the supply chain. Such information shall be relevant to the nanoforms.’ |