COMMISSION REGULATION (EU) …/…

of XXX

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)Commission Recommendation 2011/696/EU 2 sets out a definition of the term 'nanomaterial'. A nanomaterial can be a form of a substance or a distinct substance.  

(3)The Commission Communication on the Second Regulatory Review on Nanomaterials 3 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.

(4)The Commission performed an impact assessment 4 and further concluded that it is necessary to clarify the registration duties and obligations for nanomaterials. The term ‘nanoform’ should be used for the purposes of Regulation (EC) No 1907/2006 to identify any form of a substance or a distinct substance that fulfils the definition of nanomaterial.

(5)Nanoforms may have specific toxicological profiles and exposure patterns and may therefore require specific risk assessment and adequate sets of risk management measures.

(6)Without the minimum standard information in the technical dossier and the chemical safety report for substances with 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 and avoid 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.

(7)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.

(8)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.

(9)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.

(10)For reasons of workability and proportionality, it should be possible to group nanoforms with similar properties in sets and provide the characterisers of the different nanoforms or sets of nanoforms in ranges of values to allow for limited variations in actual materials placed on the market. A justification has to be provided why the sets are appropriate for the hazard assessment, exposure assessment and risk assessment of the individual nanoforms. 

(11)All different nanoforms and sets of nanoforms should be considered by the registrant in the demonstration of safety. Similarly, the information on volume, use and exposure of the different nanoforms or sets of nanoforms of the substance should be provided separately to demonstrate their safe use. 

(12)Nanoforms or sets of nanoforms 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.

(13)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 for the different nanoforms or sets of nanoforms should be provided. The relevance and adequacy of the information obtained from means other than testing should be approached in a similar manner.

(14)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.

(15)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 or sets of nanoforms. 

(16)The specific properties of the nanoform may 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 for some nanoforms. 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 methods should be provided in such cases also for low-volume substances.

(17)Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation or in very specific cases the dermal route may be considered as more appropriate route of exposure.

(18)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. In case a nanoform generates persistent inflammation, the potential for adverse outcomes should be assessed as part of short term repeated dose, sub-chronic and chronic toxicity study.

(19)The distribution of a nanoform in the body may affect the toxicological profile when compared to other forms of the same substance. Therefore, a basic assessment of the toxicokinetic behaviour should be available for the chemicals safety assessment of a nanoform, when one is required. This should allow the development of effective testing strategy or its adaptation for the substance with nanoforms with the aim of minimizing animal testing. Where needed, 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.

(20)A number of specific physico-chemical properties in addition to those used to identify the different nanoform or sets of nanoforms may be considered relevant for scientific understanding of properties of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for higher volume substances than 100 tonnes/year should be required to explicitly consider such further information in case other particle properties significantly influence hazard or exposure to those nanoforms.

(21)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 or sets of nanoforms separately. For grouping of different nanoforms or sets of nanoforms, the molecular structural similarity alone cannot serve as justification for the application of read-across or grouping.

(22)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 apply those provisions already before the deadline for compliance.

(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,

(1) OJ L 396, 30.12.2006, p. 1.

(2) Commission Recommendation of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, p. 38).

(3) COM(2012) 572 final.

(4) Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials [SWD REFERENCE TO BE ADDED LATER]

EN

ANNEX

1. Annex I to Regulation (EC) No 1907/2006 is amended as follows:

(a) Subsection 0.1. is replaced by the following:

"0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms. The requirements specific to nanoforms of a substance in this Annex apply without prejudice to requirements applicable to other forms of that substance. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration.";

(b) Subsection 0.3. is replaced by the following:

"0.3. The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The assessment shall address nanoforms that are covered by the registration. The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.";

(c) Subsection 0.4. is replaced by the following:

"0.4. 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. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or ‘category’ of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or ‘category’ of substances. The manufacturer or importer shall provide a justification for this. Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and risk management measures.";

(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 nanoforms that are covered by the registration.";

(e) Point 0.6.3 is replaced by the following:

"0.6.3. Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1.";

(f) After subsection 0.11. the following subsection 0.11.bis is added:

"0.11.bis When nanoforms are covered by the chemical safety assessment, 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, including mass metric information, is preferable. When possible, a method for reciprocal conversion shall be indicated.";

(g) The following sentence is added after the first line of section 1.0.3:

"The assessment shall address 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:

"1.3.2. 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 registrants shall indicate and justify the action or decision he has taken as a result.";

(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 nanoforms when they are covered by the registration.";

(l) Point 3.2.1. is replaced by the following:

"3.2.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.

The presentation and justification is applied to nanoforms covered by the registration.";

(m) Point 3.2.2. is replaced by the following:

"3.2.2. 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.";

(n) Point 4.0.2. is replaced by the following:

"4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report. The assessment shall address nanoforms when they are covered by the registration:

The assessment shall also be summarised in the Safety Data Sheet under heading 12.";

(o) Subsection 4.2. is replaced by the following:

"4.2. Step 2: Emission Characterisation

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address nanoforms that are covered by the registration.";

(p) The first paragraph of subsection 5.0. is replaced by the following:

"The objective of the exposure assessment shall be to make the 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 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:

"5.2.3. A characterisation of possible degradation, transformation, reaction processes, and an estimation of environmental distribution and fate shall be performed.

When nanoforms are covered by the registration, a characterisation of particle aggregation, agglomeration and particle surface chemistry changes shall be included."

2. Annex III to Regulation (EC) No 1907/2006 is amended as follows:

"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:

(i) with dispersive or diffuse use(s) particularly where such substances are used in consumer mixtures or incorporated into consumer articles; and

(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008 or for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media."

3. Annex VI to Regulation (EC) No 1907/2006 is amended as follows:

(a) The introductory text under the subtitle 'Guidance note on fulfilling the requirements of annexes VI to XI' is replaced by the following:

"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.

Where a substance being registered is also manufactured or imported in nanoform certain specific information items have to be provided. Nanoforms shall be characterised as provided in this Annex. Furthermore, the registrant of a substance with nanoforms shall justify why the information provided in the joint registration is relevant to cover the information requirements for the registered substances with nanoforms. Information relevant to cover information requirements for such substance can also be submitted separately by individual registrants, where they consider it 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 for nanoforms of a substance. The information shall be reported in such a manner that it is clear what information in the joint submission pertains to which nanoform or set of nanoforms of the substance.

The technically and scientifically justified 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.

Guidance note on nanoforms:

In accordance with the Commission Recommendation of 18 October 2011 on the definition of nanomaterial 1 , a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm, is a nanoform of a substance. The term ‘nanoform’, when it is referred to in the other Annexes, shall relate to a nanoform or a set of nanoforms that has been characterised in accordance with section 2.4 below. A substance may have one or more different nanoforms, based on differences in the parameters in points 2.4.2 to 2.4.5.

For this purpose, ‘particle’ means a minute piece of matter with defined physical boundaries; ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and ‘aggregate’ means a particle comprising of strongly bound or fused particles 2 .

The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance. The term ‘nanoform’, when it is referred to in the other Annexes, shall relate to an individual nanoform or a set of nanoforms when one has been defined in accordance with section 2.4 below.";

(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 nanoforms of the substance when they 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 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 characterized 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 (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 any of the characteristics, the information provided may be applicable to individual nanoforms or sets of similar nanoforms provided that the boundaries of the sets are clearly specified. A justification shall be provided to demonstrate why the sets are appropriate for the hazard assessment, exposure assessment and risk assessment of the individual nanoforms that are manufactured and placed on the market.

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. Particle number size distribution with indication of the number fraction of constituent particles in the size range 1 nm – 100 nm.

2.4.3. Description of surface functionalization 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; 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 identification of 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. Where QSARs are used or evidence is obtained by means other than testing, a description shall be provided of the range of material characteristics/properties 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. Where QSARs are used or evidence is obtained by means other than testing, a description shall be provided of the range of material characteristics/properties to which the evidence can be applied.";

(b) Subsection 8.5. is replaced by the following:

(c) Point 8.6.1 is replaced by the following:

(d) Subsection 8.8. is replaced by the following:

(e) Point 9.1.3 is replaced by the following:

(f) Point 9.1.4. is replaced by the following:

(g) Subsection 9.2. is replaced by the following:

(h) Section 9.2.2 is replaced by the following:

(i) Point 9.3.1. is replaced by the following:

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. Where QSARs are used or evidence is obtained by means other than testing, a description shall be provided of the range of material characteristics/properties to which the evidence can be applied.";

(b) After subsection 7.17, the following is added:

(c) Point 8.6.2 is replaced by the following:

(d) Point 9.2.1.2. is replaced by the following:

(e) Subsection 9.3. is replaced by the following:

(f) Subsection 9.4 is replaced by the following:

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. Where QSARs are used or evidence is obtained by means other than testing, a description shall be provided of the range of material characteristics/properties 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:

(1)– the proper selection and characterisation of the exposed and control groups;

(2)–adequate characterisation of exposure ;

(3)– sufficient length of follow-up for disease occurrence;

(4)–valid method for observing an effect;

(5)–proper consideration of bias and confounding factors; and

(6)– a reasonable statistical reliability to justify the conclusion.

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:

further testing on vertebrate animals for that property shall be omitted,

further testing not involving vertebrate animals may be omitted.

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:

-– results are derived from a (Q)SAR model whose scientific validity has been established,

– the substance falls within the applicability domain of the (Q)SAR model,

– results are adequate for the purpose of classification and labelling and/or risk assessment, and

– adequate and reliable documentation of the applied method is provided.

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:

(1)results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

(2)results are adequate for the purpose of classification and labelling and/or risk assessment; and

(3)adequate and reliable documentation of the applied method is provided.

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 nanoforms when they are covered by the registration. Justifications and conclusions drawn from the assessment shall be relevant to the nanoforms.

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 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 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 nanoforms when they are covered by his own uses or identified uses down the supply chain. Such information shall be relevant to the nanoforms."