WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/52/Add.3/Rev.1 
9 February 2007 
 (07-0565) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
 
Revision
 
 
 
 The following communication, dated 9 February 20 07, is being circulated at the request of the 
Delegation of the European Communities . 
 
_______________ 
 
 
Further to its communication of 17 August 2006 (G/TBT/N/EEC/52/Add.2), the European 
Communities would like to inform th e members of the Committee that: 
1. Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the 
Registration, Evaluation, Authorisation and Rest riction of Chemicals (REACH), establishing a 
European Chemicals Agency, amending Directiv e 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 
and 
 
2. Directive 2006/121/EC of the European Par liament and of the Council amending Council 
Directive 67/548/EEC on the approximation of laws , regulations and administrative provisions 
relating to the classification, packaging and labelling of dangerous substances in order to adapt it to 
Regulation (EC) No 1907/2006 concerning the Re gistration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) and establishing a European Chemicals Agency 
were adopted on 18 December 2006. Both texts were  published in the Official Journal of the  
EU L 396 of 30 December 2006. The texts of the Re gulation and of the Directive are available at:  
  http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML  
The REACH Regulation 1907/2006 will enter in to force on 1 June 2007. The Directive 
2006/121/EC shall apply from 1 June 2008. 
For further information on REACH please see also: 
http://ec.europa.eu/enterprise/reach/index_en.htm and http://ec.europa.eu/environment/c hemicals/reach/reach_intro.htm 
The Appendixes to this addendum contain a not e concerning the further developments since 
the adoption of the Common Position a dopted by the Council in June 2006. G/TBT/N/EEC/52/Add.3/Rev.1 
Page 2  
 
  The European Communities underlin es again that at all stages of the procedure it has taken 
great care to ensure that the WT O rules are respected. In the final text there is no discrimination 
between EU producers and exporters  sending substances or articles to the EU. In addition, the 
requirements have been designed to take into acc ount the specific risks derived from substances and 
are the least burdensome measures that would achie ve the objectives sought to protect human health 
and the environment. 
REACH has been developed in a climate of tran sparency and consultation. Stakeholders had 
opportunities to express their views and an Internet consultation was held on the draft proposal.  The 
EC has also had an open and constructive dial ogue with 3rd country representatives on REACH. 
  G/TBT/N/EEC/52/Add.3/Rev.1 
 Page 3 
 
 
  APPENDIX 1 
NOTE 
MAIN CHANGES FROM COMMISSION PROPOSAL 
SCOPE 
It has been made clear that waste is exempted from the REACH requirements.  In addition, it has also 
been explicitly confirmed that the Member States may also exempt substances used in the interests of 
defence. The Commission will review the scope of th e regulation five years after entry into force. 
A number of "natural substances" such as ores, ore concentrates, minerals and cement clinker are 
excluded from registration if they have not been chemically modified. In addition, the Commission will review the exemptions from registration contai ned in Annexes IV and V within 12 months after 
entry into force of REACH. 
Changes have also been made to the definitions  including that of existing substances ("phase-in 
substances"), to cover all substances listed in the European inventory of ex isting commercial chemical 
substances (EINECS), and a definition of alloys h as been added. Tonnage for phase-in-substances will 
be calculated as a three-year average as long as th ey have been manufactured or imported for 3 
consecutive years. 
REGISTRATION 
Substances on their own or in preparations  
A number of modifications to the Commission Proposal have been introduced to improve the 
workability of REACH, whilst ensuring that enough in formation is generated by industry 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 produ cers or importers of sma ll volumes of substances, 
particularly SMEs, the requirements for registration of  substances in quantities of 1 to 10 tonnes have 
been changed. A prioritisation system has been introduced where, for non-phase-in substances and for 
phase-in substances of very high concern or phase- in substances that are potentially dangerous to 
health or the environment and are used in dispersi ve ways, a defined set of information (set out in 
Annex VII), along with any additional relevant information that is re levant and available, must be 
submitted. For other substances at this tonnage leve l, only a set of physicochemical information and 
any additional relevant information that  is available must be submitted.  
The information requirements for substances manufact ured or imported in quantities of 10 to 100 
tonnes have been reduced; the most  significant change being the re productive toxicity requirements. 
No significant changes to the information requireme nts for substances manufactured or imported in 
quantities of 100 tonnes or more have been introduced  but the Commission will, within 18 months of 
entry into force, adopt criteria defining what c onstitutes adequate justification for omitting certain 
tests based on the exposure (waiving). In addition,  the first registration deadline has also been 
extended to 3.5 years after entry into force.  
REACH allows manufacturers and importers to bene fit from extended registration deadlines if they 
pre-register their phase-in substances in 12 to 18 mont h after entry into force.  To ensure substances 
of the highest concern are registered first, pre -registered substances manufactured or imported in 
volumes at or above 1000 tons; pre-registered s ubstances classified as carcinogenic, mutagenic or G/TBT/N/EEC/52/Add.3/Rev.1 
Page 4  
 
  toxic for reproduction; and potential PBTs
1 and vPvBs2, i.e. those classified as N:R50-53, 
manufactured or imported above 100 tonnes; are required  within 3.5 years of entry into force.  For 
other pre-registered substances, the obligation to regi ster is staggered with further deadlines of 6 and 
11 years after entry into force, which will ensure th at chemical operators have sufficient time to adapt 
to the REACH requirements.   For substances that are not pre-registered, the registration requirement 
applies as from one year after into force of the Regulation. 
In addition, the use of 'use and exposure categorie s', in terms of generi c exposure scenarios is 
specifically allowed, and the application of Good  Laboratory Practice (GLP) has been limited to 
toxicological and eco-toxicological tests and analyses. 
To reduce costs for industry and the authorities, regi strants are required to jointly submit information 
on the hazards of a substance and its classification, and can, if they agree, also jointly submit the 
chemical safety report. In particular, this inform ation must be submitted by one company (the lead 
registrant) on behalf of the others; the other registrants having to submit other information 
individually, such as their company details and their production volume. However, manufacturers and 
importers are allowed to opt out of the joint submi ssion of registration dossiers if this would result in 
excessive cost, if they disagree with  the lead registrant on the interpretation of information, or if 
disclosure of confidential information would cause  substantial commercial damage. In addition, 
several changes have been made with a view to reducing animal testing to an absolute minimum 
necessary, including the quick implementation of new alternatives to animal tests. 
Substances in articles 
Substances that are intentionally released from ar ticles will in principle be treated like all other 
substances and must be registered according to th e periods of 3.5, 6 and 11 years that apply to 
substances on their own or in preparations. In add ition, all substances of ve ry high concern (on a list 
of candidate substances for authorisation that will be produced by the Agency) present in articles 
above a concentration limit of 0.1% weight by we ight and present above 1 tonne per year must be 
notified to the European Chemicals Agency, excep t where exposure to humans and environment can 
be excluded throughout the life-cycle.  
As a safety net, the Agency can require a registration of a substance in an article at any time when it 
considers that its release poses a risk to human health or the environment. 
Finally, upon request by consumers, safety info rmation should be provided for articles containing 
substances of very high concern, including as a minimum the name of the substance. 
DATA SHARING  
The rules on data sharing set out to reduce testi ng on vertebrate animals and to reduce costs to 
industry, have also been changed. Mandatory data  sharing does not apply any more only to data from 
animal tests but also to data from non vertebrate anim al studies that must be shared on the request of a 
potential registrant. 
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 for the purposes of pre-registration has been reduced, more 
flexibility has been introduced in the functioning  of the Substance Information Exchange Fora 
(“SIEF”), and a mechanism has been set up to make  it easier for downstream users to find alternative 
suppliers that can pre-register their substances when  their original suppliers have decided not to pre-
                                                      
 1 Persistent Bioaccumulative and Toxic Substances. 
 2 Very Persistent and very  Bioaccumulative substances.  G/TBT/N/EEC/52/Add.3/Rev.1 
 Page 5 
 
 
  register.  
INFORMATION IN THE SUPPLY CHAIN 
The communication requirements of REACH have been clarified in that Safety Data Sheets are now 
required for substances that are PBTs3 or vPvBs4, and preparations containing them and has also 
clarified the duties of distributors. 
DOWNSTREAM USERS 
It has been clarified that downstream users can par ticipate in SIEFs and that they can apply a system 
of brief general descriptions of uses to identify thei r uses to the supplier.  In addition, an exemption 
from the obligation to have uses covered by a chem ical safety report has been introduced for 
substances under 1 tonne per year.  
EVALUATION 
The Agency has been given a more central role th an 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 transferred 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 Agency, with input from Memb er States. In addition, whilst assessing whether further testing is 
necessary, the Agency will also invite third parti es to submit information that would avoid the need 
for vertebrate testing. 
AUTHORISATION 
A number of changes to authorisation have st rengthened the incentive to substitute dangerous 
substances. It has been clarified that adequa te control is not a sufficient ground for granting 
authorisations in the case of substances that are PBTs, vPvBs, including those that are identified as 
substances of equivalent concern, or where it is not  possible to determine a safe threshold. Six years 
after the entry into force of the regulation, th e Commission will review whether endocrine disrupters 
should also be excluded from the adequate control route.  
To make the system more transparent and facilitate  planning within industry,  a list of substances 
eligible for being subject to an authorisation re quirement (“candidate list” ) will be published by the 
Agency.  Substances in the candidate list will be in serted in Annex XIV (i.e. substances for which an 
authorisation is required) on the basis of a recommendation from the Agency, taking into consideration comments from interested parties.  
Applications for authorisations should always incl ude an analysis of possible alternatives by the 
registrant. If this analysis shows that suitable alte rnatives are available then the application must also 
include a substitution plan. If not, information on relevant research and development activities must 
be provided, if appropriate. 
Furthermore, the criteria to identify substances of equivalent concern, on a case-by-case basis, were 
also changed to require scientific evidence of a probable serious effect to human health or the 
environment. The European Commission will devel op guidance to clarify the criteria in close co-
operation with industry, Member States  and other relevant stakeholders. 
                                                     
 
3 Persistent, Bioaccumulative and Toxic substances. 
4 Very Persistent and very  Bioaccumulative substances. G/TBT/N/EEC/52/Add.3/Rev.1 
Page 6  
 
  In setting the length of a review period, it has been clarified that the Commission will take into 
account relevant information, including the risks of  the substance and of a lternatives, socio-economic 
benefits, analysis of alternatives and any subs titution plan. If suitable substitutes have become 
available by the time of the review, the Commission may amend or withdraw the authorisation, even one granted under the adequate control route. 
RESTRICTIONS 
A transitional period has been introduced to faci litate the transition from the national measures 
implementing the Community restrictions on the marketing and use of chemicals to the restrictions provisions of the REACH Regulation, which are directly applicable. In  addition, it has been clarified 
that a substance that has been pr ohibited or restricted under Regula tion (EC) n° 850/ 2004 on persistent 
organic pollutants (POP s) cannot be authorised under REACH.   
EUROPEAN CHEMICALS AGENCY 
As already mentioned above, the Eu ropean Chemicals Agency will have  a greater role to play in the 
evaluation of substances. In additi on, a number of structural changes have been introduced, such as 
increased Member State representation on the Management Board and independent representatives 
nominated by the European Parliament.  
CLASSICATION AND LABELLING INVENTORY  
The types of substances that can be given EU harmonised classifications have been extended to 
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 and respiratory sensitisers. 
ACCESS TO INFORMATION 
The rules on access to information have been modified  with a view to bringing its provisions in line 
with Regulation (EC) N° 1049/2001 regarding public access to Eur opean Parliament, Council and 
Commission documents. It provides that the detaile d rules for access to information held by the 
Agency should be drawn up by the Agency's Manage ment Board in accordance w ith the provisions of 
the Aarhus Convention and with Regulation (EC) No 1049/2001.  
The Agency is required to publish non-confidential information on its website but allows industry to 
justify why some of the potentially non-confid ential information should not be published. 
OTHER ISSUES 
REACH will enter into force on 1 June 2007 and the European Chemical s Agency will become 
operational 12 months later, in time for the first registrations of substances. 
Workability, cost-effectiveness and a smooth operati on of the REACH system is of key importance 
for the European institutions. Guid ance material for manufactures and importers is currently being 
prepared with the participants from tradi ng partners in stakeholder experts groups. 
Up to date information will be available on the Eu ropean Commission’s website  and the help-desk of 
the new European Chemicals Agency will also provide  relevant assistance. The Agency may also be 
asked to provide technical assistance to the deve loping countries concerned when appropriate.   G/TBT/N/EEC/52/Add.3/Rev.1 
 Page 7 
 
 
  APPENDIX 2 
NOTE 
MAIN CHANGES FROM COMMON POSITION 
SCOPE 
There have not been changes on the scope but the Commission will review the scope of the 
Regulation five years after entry into force. In a ddition, the definition for tonnage has been changed 
for phase-in-substances and it now will be calculate d as a three-year average as long as they have 
been manufactured or imported for 3 consecutive years. 
REGISTRATION 
Substances on their own or in preparations  
The first registration deadline has been extended to 3.5 years after entry into force. In addition, several 
changes have been made regardi ng the welfare of animals used in experiments, including the quick 
implementation of new alternatives to animal tests.  A mechanism has been set up to help downstream 
users find alternative suppliers that are able to pr e-register their substances where their original 
suppliers fail to do so.  
Substances in articles 
Information on safe use of articles containing substa nces of very high concern will be made available 
to consumers on request. 
DATA SHARING  
More flexibility has been introduced in the functioni ng of the SIEF (in particular, there is no deadline 
by which SIEF members must identif y their information needs).  In a ddition, it has been clarified that 
downstream users and other third parties that subm it relevant information are SIEF members but that 
only potential registrants are entitled to request informa tion.  Finally, the period of data protection for 
studies and tests develop to meet the obligation under REACH has been extended to 12 years. 
EVALUATION 
When assessing whether further testin g is necessary, the Agency will also invite third parties to 
submit information that would avoid the need for vertebrate testing. 
AUTHORISATION 
PBTs, vPvBs and substances of equivalent concer n have been specifically excluded from the the 
adequate control route. Six years after the entry into force of the regulation, the Commission will 
review whether endocrine disrupters should also be excluded from the adequate control route.  
If the applicant’s analysis of alternatives shows that suitable alternatives are available then the 
application must also include a substitution plan . If not, information on relevant research and 
development activities must be provided, if appropriate. 
In setting the length of a review periods, it has been clarified that the Commission will take into 
account relevant information, including the risks of  the substance and of a lternatives, socio-economic 
benefits, analysis of altern atives and any substitution plan. G/TBT/N/EEC/52/Add.3/Rev.1 
Page 8  
 
  If suitable substitutes have become available by th e time of the review, the Commission may amend 
or withdraw the authorisation, even one granted under the adequate contro l route. In such cases the 
Commission will require the holder of the au thorisation to present a substitution plan. 
EUROPEAN CHEMICALS AGENCY 
In addition, to the structural changes introdu ced in the Common Position the representation on the 
Management Board has been increased to include  representatives of the European Parliament.  
 
__________