EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
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 
subs tances  
(Text with EEA relevance)    
EN 2   EN 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 
subs tances  
(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 R egistration, 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 Counc il Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, 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 
devel op and recommend appropriate risk management measures.  
(2) Commission Recommendation 2011/696/EU2 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 
Nanomaterials3 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 fr amework are 
necessary.  
(4) The Commission performed an impact assessment4 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.  
                                                 
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 o f nanomaterials 
[SWD REFERENCE TO BE ADDED LATER]   
EN 3   EN (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. Cla rifications 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 implement ation 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 
adeq uately 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, potenti ally 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 alt ernatively 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 infor mation 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 nanoform s of a substance.  
(9) For nanoforms, specific minimum characterisation informatio n 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 envi ronment.  
(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 varia tions 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  
EN 4   EN 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 cond itions 
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 inh alable 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(i es) 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 histopatholo gical 
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 generate s persistent inflammation , the potent ial 
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. Th erefore, 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 accord ance 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 p roperties 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  
EN 5   EN 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 f or 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 substan ces 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 appl ication 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 (E C) No 1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es 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 g enerating 
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 appl y from 1 January 2020.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 6   EN Done at Brussels,  
 For the Commission  
 The President  
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