WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/52/Add.2 
17 August 2006 
 (06-3943) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  
 The following communication, dated 10 August 2006,  is being circulated at the request of the 
Delegation of the European Communities
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 The European Communities would like to info rm the members of the Committee that the 
Common Position on the REACH proposal was adopted by the Council on 27 June 2006.  The text of the Common Position is available at:   http://ec.europa.eu/enterprise/tbt/nview.cfm?p=EEC_52_EN
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 For further information on REACH please see also:  http://ec.europa.eu/enterprise/reach/index_en.htm
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 The Appendix to this addendum contains a not e concerning the main changes in the Common 
Position regarding the Commission proposals.  
 The European Communities underlin es that at all stages of the procedure, both in the initial 
proposal and in the advice to th e Council, the European Commission has taken great care to ensure 
that the WTO rules are respected.  In the Council’s text there is no discrimination between EU 
producers and exporters sending substances or articles to the EU.  In addition, the requirements take 
into account the need to address the risks from substances and are least burdensome taking into 
account the objectives sought to improve health and the environment. 
 REACH has been developed in a climate of tr ansparency and consultation.  The European 
Commission often met with stakeholders, and an Inte rnet consultation was held on the draft proposal.  
The European Commission has had an open and constructive dialogue with third country 
representatives on REACH. 
 The view of the European Commission is that the Council's Common Position on REACH is 
WTO compatible but, of course, the European Commi ssion will maintain its vigilance on this matter 
during the second reading. G/TBT/N/EEC/52/Add.2 
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  APPENDIX 
N
OTE 
Main changes in Common Position from Commission proposal 
SCOPE 
In its Common Position, the Council has made  explicit some exemptions from the REACH 
requirements as a whole that the Commission had seen as implicit, i.e. for waste and, if the member 
States desire it, for substances used in the interests of defence.  In addition, the exemptions relating to 
different Titles of REACH - Registration, Inform ation in the Supply Chain, Downstream Users, 
Evaluation, Authorisations and Restrictions  - have been consolidated in title I.  
The Council also made changes to the defin itions including that of existing substances 
("phase-in substances"), to cover all substances listed in the European inventory of existing 
commercial chemical substances (EINECS) , and added a definition of alloys. 
The Council also decided to exclude from regist ration a number of "natural substances" such 
as ores, ore concentrates, minerals and cement cli nker.  In addition, the Common Position requires the 
Commission to review the Registration exemptions, contained in Annexes IV and V, within 
12 months after entry into force of REACH. 
In addition, it is now possible for a manufactur er, importer or downstre am user to appoint a 
third party to represent them in discussions with other companies for the purposes of registration and 
data-sharing.  
REGISTRATION 
Substances on their own or in preparations  
The Council's Common Position has introdu ced a number of modifications to the 
Commission Proposal that is aimed at making the sy stem more workable, whilst ensuring that enough 
information is generated by industr y to allow a substance to be used safely and information to be 
made available to the authorities and downstream users.  
In this context, to reduce the impact on SMEs, the requirements for registration of substances 
in quantities of 1 to 10 tonnes have been changed by the Common Position.  A prioritisation system 
has been introduced where, for non-phase-in substa nces, substances of very high concern, and 
substances that are potentially dangerous to health or the environment and are used in dispersive 
ways, a defined set of information (set out in A nnex VII) along with any other available information 
must be submitted.  For other substances at th is tonnage level only a set of physicochemical 
information and any available information need to be submitted. 
For substances manufactured or imported in qua ntities of 10 tonnes or more per manufacturer 
or importer and year, the Common Position now requi res only one test for reproductive toxicity.  The 
Common Position did not introduce significant ch anges to the information requirements for 
substances manufactured or imported in quantities of 100 tonnes or more but did require, within 
18 months of entry into force, the Commission to adopt criteria defining what constitutes adequate 
justification for omitting certain tests based on the exposure (waiving).  G/TBT/N/EEC/52/Add.2 
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  To ensure substances of the highest concern were registered first the Council decided to 
require the registration of potential PBTs1 and vPvBs2, i.e. those classified as N:R50-53, 
manufactured or imported above 100 tonnes within three years of entry into force.  
In addition to this the Common Position also  now allows the use of 'use and exposure 
categories', in terms of generic exposure scenarios,  and limits the application of Good Laboratory 
Practice (GLP) to toxicological and eco-toxicological tests and analyses. 
To reduce costs for industry and the Authorities, the Common Position requires registrants to 
jointly submit information on the hazards of a substa nce and its classification, and can, if they agree, 
also jointly submit the chemical safety report.  The information is submitted by one company on 
behalf of the others (the lead registrant); the other registrants have to  submit other information 
individually, such as their company details a nd their production volume.  However, manufacturers 
and importers are allowed to opt out of the joint subm ission of registration dossiers if this would result 
in excessive cost, if they disagree with the lead re gistrant on the interpretation of information or if 
disclosure of confidential information w ould cause substantial commercial damage. 
Substances in articles 
In its Common Position the Council made a number of significant changes to the 
Commission's proposal. 
Substances that are intentionally released from articles will in principle be treated like all 
other substances and registered according to the phase-in periods of 3, 6 and 11 years.  In addition, all 
substances of very high concern (on a list of candi date substances for authorisation that will be 
produced by the Agency) present in articles above a c oncentration limit of 0.1% weight by weight and 
present above 1 tonne per year must be notified to  the Agency, except where exposure to humans and 
environment can be excluded throughout the life-cycle. 
As a safety net, the Agency can require a registra tion of a substance in an article at any time 
when it considers that its release poses a ri sk to human health or the environment. 
DATA SHARING  
The rules on data sharing, set out to reduce testing on vertebrate animals and to reduce costs 
to industry, have also been cha nged in the Common Position.  Manda tory data sharing does not apply 
any more only to data from animal tests but also to data from non vert ebrate animal studies that must 
be shared on the request of a potential registrant or a member of a Substance Information Exchange 
Forum. 
In addition, one pre-registration period of 12 to  18 months after the entry in force has been 
introduced, the amount of information to be submitted has been reduced and the workings of the SIEF 
have been clarified.  
INFORMATION IN THE SUPPLY CHAIN 
The Common Position has clarified the communication requirements of REACH in that 
Safety Data Sheets are now required for substa nces that are PBT and vPvB and preparations 
containing them and has clarified the duties of distributors. 
                                                      
 1 Persistent Bioaccumulative and Toxic Substances 
 2 Very Persistent and very Bioaccumulative substances G/TBT/N/EEC/52/Add.2 
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  DOWNSTREAM USERS 
The Common Position has clarified that downstream users can participate in SIEFs, apply a 
system of brief general descriptions of uses (to be developed in guidance) to identify their uses to the 
supplier, and has added a threshold for this ob ligation of 1 tonne per substance per year.  
EVALUATION 
In the Common Position, the Council has given the Agency a more central role than foreseen 
in the Commission proposal, in that responsibility for dossier evaluation, i.e. checking that registration 
dossiers are correct and whether further testing is necessary, has been transfe rred to the Agency while 
substance evaluation will be carried out by member  State competent authorities based on a single EU-
wide rolling plan prepared by the Agen cy, with input from member States.  
AUTHORIZATION 
The agreement by the Council on authorisati on strengthens the incentive to substitute 
dangerous substances.  The Council decided that adequate control is not a sufficient ground for 
granting authorisations in the case of substances that are PBT, vPvB, or where it is not possible to determine a safe threshold.  The Commission will re view whether to include some other substances 
where it is possible to determine a threshold within 12 months of entry into force. 
To make the system more transparent and facilita te planning within industry, a candidate list 
of substances meeting the authorisation criteria will be published by the Agency.  The Agency will 
publish a list of substances meeting the criteria a bove and reflecting its multi-annual work plan, taking 
into consideration comments from interested parties.   In addition, applica tions for authorisations 
should always include an analysis of possible alternatives by the registrant. 
Furthermore, the criteria to identify substances of equivalent concern, on a case-by-case basis, 
were also changed so scientific evidence of a prob able effect would be required.  The European 
Commission will develop guidance to clarify the crite ria in close co-operation with industry, member 
States and other relevant stakeholders. 
RESTRICTIONS 
 The Council has included in its Common Position a transitional period after REACH comes into 
force to allow member States to update existing national legislation relating to current restrictions on the marketing and use of chemicals.  In addition, the Common Position excludes persistent organic 
pollutants (POPs) from REACH, thus maintaining such POPs within the scope of Regulation (EC) n° 850/2004. 
EUROPEAN CHEMICALS AGENCY 
As already mentioned above, the European Chemicals Agency will have a greater role to play 
in evaluation of substances.  In addition, th e Common Position introduces a number of structural 
changes, such as increasing member State representation on the Management Board.  
CLASSIFICATION AND LABELLING INVENTORY  
The Common Position extends the EU harmonise d classifications to also include other 
substances justified on a case-by-case basis besides the substances that are already included, i.e. 
category 1, 2 and 3 CMRs, respiratory sensitisers.  G/TBT/N/EEC/52/Add.2 
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  ACCESS TO INFORMATION 
The Common Position modifies the rules on access to information with a view to bringing its 
provisions in line with Regulation (EC) N° 1 049/2001 regarding public access to European 
Parliament, Council and Commission documents.  It  provides that the detailed rules for access to 
information held by the Agency should be drawn up by the Agency's Management Board in 
accordance with the provisions of the Aarhus C onvention and with Regula tion (EC) No 1049/2001.  
The Common Position also requires the Agency to publish non-confidential information on its 
website but allows Industry to justify why some of  the potentially non-confidential information should 
not be published.  
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