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REACH REGULATION
PUBLIC INTERNET CONSULTATION

CHEMI PLATFORM

A - Contact details
(Please enter your contact details)

CHEMI PLATFORM
The following industries participate in the CheMI Platform

Name Industry
AFERA Pressure sensitive tape
BLIC Rubber industry
CEI BOIS Woodworking industries
CITPA Paper and board converters
COTANCE Leather and leather goods
ECMA Carton Makers
EURATEX Textile industry
FESPA Screen printing
FINAT Self adhesive labels (Manufacture & printing)
Flexible Packaging Europe (FPE) Flexible packaging materials
INTERGRAF General printing, security printing
SEFEL Metal packaging
TIE Toys industry
UEA Furniture industry

Full names, addresses, contact points etc. for the associations and federation mentioned can be found in the appendix to these comments.
The secretariat of the CheMI platform is jointly run by:
IntergrafMs.Anne-Marie DeNooseSquare Marie-Louise 18, Bte 25-27B-1000 Brussels, BelgiumTel: +32 2 230 86 46Fax: +32 2 231 14 64Mail: amdenoose@intergraf.org CotanceMs.Eva M.Carballeira Fernández3 Rue BelliardB-1040 Brussels, BelgiumTel: +32 2 512 77 03Fax: +32 2 512 91 57Mail: emcf@euroleather.com

B - Confidentiality

0 I would like my identity to be kept confidential
(please leave this box blank if you agree that your name and organisation will be identified on the Commission’s website for public access)

C - SME

x Are you a small or medium sized enterprise? (EC legal definition)
please specify the number of members:

See section 1 of the comments

D - Description of your primary activities
(please select only one of the following)

Industry

0 Manufacturer
0 Importer
0 Downstream user
0 Distributor
x Trade association
0 Other

NGO

0 Environmental group
0 Animal welfare group
0 Trade union
0 Consumer organisation
0 Other

Public authorities

0 EU Member State government
0 Other national government
0 International organisation
0 National or regional authority

Other

0 Academic or technical institute
0 Worker in chemicals or downstream industry
0 EU citizen
0 Other

Please structure your response according to the following topic areas and provide comments or proposals for amendments to the legislation. Please comment on those topics that are relevant to you.

When finished, please send your document to the following address:
entr-env-ec-reach@cec.eu.int.

Thank you in advance for your contribution.

E - Topics :

1. Duty of care
2. Chemical safety assessment
3. Information flow
4. Registration procedure
5. Polymers
6. Intermediates
7. Data requirements
8. Data sharing/consortia formation
9. Procedures for downstream users
10. Evaluation procedure
11. Authorisation procedure
12. Restrictions procedure
13. The Agency
14. Other

The comments below are a summary of the most important comments that are common to all of the platform members. These summary comments are not easily grouped by regulation title. They are grouped per subject of importance to these industries
The individual comments by participating industries will be structured according to the topics mentioned above.

CONSULTATION DOCUMENT ON CHEMICALS LEGISLATION

WORKABILITY COMMENTS

by the industries represented in the
CHEMI PLATFORM

TABLE OF CONTENTS

1. Industries 6
2. Contact details 8
3. Confidentiality 8
4. Common characteristics 9
5. Summary Comments 10
5.1 Consistency 10
5.2 Preparations 10
5.3 Manufacturers of articles 11
5.4 Language and complexity 12
5.5 Material Safety Data Sheets 12
5.6 Communication up the supply line 13
5.7 Co-operation between users 15
5.8 Inefficient use of existing knowledge, infrastructure & legislation 15
5.9 Overly prudent classification and labelling 16
5.10 Exemptions 16
5.11 Timing & Pilot Phase 16
5.12 Exposure data 17
5.13 Polymers 17
5.14 Agency 18

APPENDIX
Industry descriptions

1. INDUSTRIES
The comments below are given on behalf of the CheMI Platform. All members of the platform are industries manufacturing articles. The manufacture of chemical substances and preparations is not part of their business.
Name Industry Some numbers EU 15
AFERA Pressure sensitive tape No of companies:Employees:Average employment: 5412.000222,2
BLIC Rubber industry No of companies:EmployeesAverage employment: 1.200280.000233,3
CEI BOIS Woodworking industries No of companies:Employees:Average employment: 42000190000045.2
CITPA Paper and board converters No of companies:Employees:Average employment: 5.000380.00076,0
COTANCE Leather and leather goods No of companies:Employees:Average employment: 3.04356.40018,5
ECMA Carton Makers No of companies:Employees:Average employment: 11005500050
EURATEX Textile industry No of companies:Employees:Average employment: 114.000 2.100.0018,4
FESPA Screen printing No of companies:Employees:Average employment: 55.000600.00010,9
FINAT Self adhesive labels (Manufacture & printing) No of companies:Employees:Average employment: 2.50050.00020,0
Flexible Packaging Europe (FPE) Flexible packaging materials No of companies:Employees:Average employment: 40043.000107,5
INTERGRAF General printing, security printing No of companies:Employees:Average employment: 105.000859.0008,2
SEFEL Metal packaging No of companies:Employees:Average employment: 26540.300152,1
TIE Toys industry No of companies:Employees:Average employment: 2.000100.00050,0
UEA Furniture industry No of companies:Employees:Average employment: 8880092500010.4

In total the participating industries in the CheMI Platform consist of over 420.000 manufacturing companies, almost all of which SME’s and for the vast majority truly very small, mini or micro enterprises. In total they employ over 7.4 million workers; on average no more than 17.6 per company.

It must be noted however that in most of these industries, some 20% of the member companies employ some 84000 workers, ie 70.4% of all personnel. In consequence, much more than half the number of companies employ far fewer personnel than indicated by the average. The 20% ‘large’ companies, some 57.700, in total employ on average 62,2, where the 80% ‘small’ companies, some 230.800 employ on average 3,9.
Also, most of the figures above concern the federations’ membership. The smaller a company however, the less likely that it is indeed a member. Therefor, if such statistics were available, figures including the non-member companies would show an even larger number of mini- and micro-enterprises.
2. CONTACT DETAILS
Full names, addresses, contact points etc. for the associations and federation mentioned in section 1 can be found in the appendix to these comments.
The secretariat of the CheMI platform is jointly run by:
IntergrafMs.Anne-Marie DeNooseSquare Marie-Louise 18, Bte 25-27B-1000 Brussels, BelgiumTel: +32 2 230 86 46Fax: +32 2 231 14 64Mail: amdenoose@intergraf.org CotanceMs.Eva M.Carballeira Fernández3 Rue BelliardB-1040 Brussels, BelgiumTel: +32 2 512 77 03Fax: +32 2 512 91 57Mail: emcf@euroleather.com

3. CONFIDENTIALITY
These comments are not confidential. No names need to be withheld from publication.

4. COMMON CHARACTERISTICS
A short description for each of these industries can be found in the appendix to these comments.
All these industries are ‘end user’ industries; they are the last user of the chemicals in the supply chain. They have a number of important characteristics in common, which very much determine the workability of the new chemicals policy in these industries:
· Chemicals are primarily used in the shape of preparations. These preparations come in the form of inks, adhesives, varnishes, other coating materials, cleaning agents, maintenance products, developing and fixing agents, screen fillers, photo stencil emulsions, abrasives, adhesion promoters, lubrication oils, oil mists, washer chemicals, etc.. etc..
· Even in the smallest companies several hundred different preparations are normally often used. Many of which of course in very small quantities.
· These preparations always consist of several different substances. The number of different substances varies with the kind of preparation. Inks will contain between 10 and 30 different substances, adhesives up to 40, can coatings on average 20. On average the preparations used in these industries contain some 20 different substances.
· Though different preparations may make use of the same substances, the total number of different substances will may easily be over a thousand in even the smallest manufacturing companiescompany.
· Chemicals in the shape of substances on their own are also used. These may for instance be solvents. The volume per substance on it’s own may be relatively substantial, but the number of different substances used on their own will always be far smaller than the number of different preparations and vastly smaller than the number of substances in these preparations.
· In many cases preparations will, before use, be mixed with other preparations or substances on their own. Inks need to be diluted, coloured varnishes need to be mixed, additives may be added to influence characteristics such as drying speed, viscosity, pH etc.
· Preparations that are used for one and the same purpose will often be bought from several different individual manufacturers. For reasons of maintaining competition, several different adhesive or coating manufacturers will for instance supply very similar products to the same company. The exact composition of these preparations will however differ between suppliers.

5. SUMMARY COMMENTS
The comments below regard only the workability of the proposal. Improved workability would off course reduce costs, but it would reduce the economic impact of REACH on the industries participating in the CheMI platform for only a small part. Comments regarding the economic impact of the proposed regulation will be provided separately.
The comments below are a summary of the most important comments that are common to all of the platform members. These summary comments are not easily grouped by regulation title.
Members of the CheMI platform will however individually or in smaller groups provide detailed and title by title industry specific comments,.
5.1 Consistency
The draft regulation misses definitions for a number important concepts such as: exposure scenario, chemical safety report, chemical safety assessment, material safety data sheet, immediate down stream user, Community authorisation, Member State authorisation, consumer, end user, supplier.
The definition of “putting on the market” could be read as if the end user puts waste on the market, and would therefore provide the collector of the waste with a chemical safety report.
The interpretation of the articles is not always simple and in some cases more than one interpretation seems possible. An explanatory memorandum is missinged.
In several places the regulations speaks of ‘not adversely affecting’ the environment. Almost any release to the environment will to some extent ‘affect adversely’. A term more consistent with the intentions of the regulations should be used.
The annexes are in contradiction with the regulation. The regulation itself does not mention the need for exposure data. This is consistent with the logical idea that the exposure scenarios should be based on the assumption that the recommended chemical safety measures are implemented by the user. The annexes however stress the importance of exposure data.
See also § 5.12 ‘Exposure data’.
5.2 Preparations
The proposed regulation does not at all take into account the fact that all the many hundreds of thousands of European manufacturers of articles mainly use chemicals in the shape of preparations. Even in the smallest manufacturing plant, over a hundred and occasionally over a thousand different preparations will be in use. Substances on their own will also be in use, often even in large quantities, but never in numbers approaching the number of different chemicals in preparations.
As described in section 4, almost every raw material in use is a preparation. On average these preparations contain some twenty different chemicals. Overall, even in the smallest manufacturing plant, well over a thousand different chemicals will frequently be in use. Where the volume of chemical safety reports are expected to vary between 20 and 200 pages, the total volume of the chemical safety reports, in even the smallest manufacturing plants, may easily exceed 100.000 pages. The administrative workload of reading and storing all this information is way beyond the capacities, with regard to both management time and finances, of these small enterprises. In addition Material Safety Data Sheets will also be sent to the user of the preparation.
Many of the chemicals occur in preparations only in minute quantities. Also, many of the preparations in use are no more than products also sold to consumers.
According to the regulation text, these manufacturers of articles will have to make a chemical safety assessment for each and every one of the chemicals used, regardless whether they are used in preparations or on their own. Even though these assessments may be based upon the chemical safety reports from the suppliers of the chemicals, the need to make hundreds or thousands of these assessments in every single plant manufacturing articles, regardless of their use in preparations, regardless of the quantities in use, regardless of the fact that they may be simple consumer products and regardless of any hazard or risk, will generate an enormous amount of very time consuming bureaucracy. Simplification is necessary.
· For preparations there is a great need for one single and simple document to be supplied by the manufacturer. This single document should be the Material Safety Data Sheet. (See also § 5.5 ‘Material safety data Sheets’)
· For preparations, one single end-user chemical safety assessment should suffice.
· ‘End users’ should not have to document their chemical safety assessment when they simply apply safety management measures as recommended by the supplier.
· In order to reduce the number of assessments, there is a need for an exemption to make chemical safety assessment for preparations or substances on their own that are not overly hazardous and that are used in small quantities and for preparations that are also sold directly to consumers
5.3 Manufacturers of articles
The regulation only differentiates between on the one hand ‘manufacturers and importers of chemicals’ and on the other hand ‘down stream users of chemicals’. This is an insufficient differentiation. It does not take into account that, as mentioned above, the European Union counts many hundreds of thousands of manufacturers of articles, each using hundreds or thousands of different chemicals, of which the vast majority in the shape of preparations.

In order to allow for important differences in characteristics it is necessary to distinguish between:
· Manufacturers or importers of substances
· Manufacturers or importers of preparations
· Manufacturers of articles, or ‘end-users’
· Importers of articles

· It is proposed that this distinction is made in the regulation.
5.4 Language and complexity
Personnel in small, mini and micro enterprises have great difficulty in understanding complex texts in any other than their own language. This is the more the cases with technically complicated documents. It is completely useless and probably counter productive to provide small manufacturing enterprises with thousands and thousands of pages of complex information in a foreign language.
· All the information supplied to end users should be readable to non specialists and in the language of the end user.
A similar problem will occur with registration and pre-registration. Where end-users need to determine whether their particular use has been registered or pre-registered, they will need to be able to read the submissions. With submissions in Finish, Greek, Latvian etc, this will be particularly difficult for the majority of users. In this case it is possibly not necessary to submit the information in all EU languages. It may be enough if the registration is submitted in a number of commonly readable languages like English, French and German. Since the information about intended uses is very special and will be prone to translation mistakes, the translation should be done by the submitter himself and not by an EU institution of or Member States.
· The information concerning the intended use of substances in registration and possibly pre-registration needs to be submitted in more than just the language of the submitter.
5.5 Material Safety Data Sheets
The Material Safety Data Sheet will remain in existence. Thus, according to the regulation, for every chemical, two different documents regarding the safe use will reach the end user: an MSDS and a Chemical Safety report. A double paper flow, largely covering the same subjects twice.
· One single document per preparation or per substance used on it’s own is more than enough. The MSDS is best suited for this purpose.
Using the MSDS as the basis for the information to end users will also solve several other problems. For the MSDS, large numbers of standard phrases in all the EU languages already exist. Remaining language problems can simply be resolved by increasing the number of these standard phrases. The MSDS also allows non dangerous substances in preparations to remain unmentioned and provides a system of safety thresholds that filters out the need to provide information on non relevant quantities of hazardous chemicals. Thus the system simplifies the user’s safety assessment and also allows formulations to remain preserve trade secrets, without endangering workers or consumers health.
· The MSDS for preparations should however be expanded in accordance with some of the ideas behind the Chemical Safety report and cover a number of additional topics. The MSDS should cover not only the preparations as sold, but also the preparation as actually used; after intended dilution or blending. This is the more important in industries where several preparations need to be mixed according to certain recipes before they can be used.
· The MSDS should also cover the preparation after it’s use, when it’s composition has changed, for instance through intended chemical reactions or the evaporation of solvents.
· In order to ensure completeness and for the benefit of enforcement, there should also be an obligation to provide a, very simple, Material Safety Data Sheet for non-hazardous preparations; mainly saying that the preparation is indeed non-hazardous.
· When the MSDS is to be used as an alternative to the Chemicals Safety Reports for preparations, it should be possible for competent authorities in the Member States to address directly the provider of a faulty Safety Data Sheet, rather than only having the right to communicate through the user of the preparation or substance.
· The distinction made in Directive 1999/45/EC between dangerous and non dangerousnon-dangerous preparations should be safeguarded. This distinction is based on the use of substances in preparations below certain concentration limits specified in the directive whichdirective, which then results in the classification of the preparation as dangerous. The merits of this system are recognised under point 16 (2), 45 and 95-98 of the proposed regulation.
· A clear classification of a preparation in the MSDS as dangerous would indicate the necessity for a Chemical Safety Assessment by the user, otherwise it can be used without any risk to health and environment. Using this system will solve several workability issues. It would very much reduce the administrative burden and cost.
· Where in the vast majority of cases the MSDS for the preparation would suffice, it must still be possible for the user to ask for additional information if he feels this is necessary for his Chemical Safety Assessment.
5.6 Communication up the supply line
According to the regulation text, end users of chemicals are to report to the Agency whenever their use of the chemical is not covered by the supplier’s chemical safety report or whenever they employ safety measures that differ from those recommended.
Considering the number of end-users, the number of different preparations and the number of different chemicals in use, this cannot possibly be an efficient procedure. Descriptions of use will be prone to misinterpretation, especially across language barriers. Many millions of communications will go down the supply line. If all these end users were to do as the regulation requires, not withstanding the 250 kg threshold, simple miscommunications between suppliers and users alone would be enough to completely drown the Agency in down stream user reports.
· It will be far more efficient to encourage users and suppliers to resolve interpretation problems and differences in opinion about matters as the description of the intended use, the practical applicability of safety measures etc between themselves. Once such an issue is resolved, the supplier can adapt his chemical safety report as necessary. No need to involve the Agency, unless the user goes his own way completely, different from any reasonable recommendation by the supplier.
· During the time needed to resolve these differences, the end user should however be allowed to use the chemical, provided it does not concern a chemical subject to authorisation and provided the end user can substantiate that his safety measures are adequate.
Such a procedure would also greatly help manufacturers of substances and preparations to attain a 100% coverage of the use of the chemicals produced. A 100% coverage of the uses is most important to the industries who, even though they use only relatively small amounts of the chemical in question, are dependent on their ability to continue it’s use. The expected wide scale discontinuation of the manufacture of speciality chemicals will be bad enough; additional problems through incomplete listings of the use of chemicals should at all cost be avoided.
It would be in the interest of the end user to make his particular use known to the supplier, as in most cases the particular use will be taken up in the supplier’s chemical safety report, which would avoid the need of end-user communication with the agency.
Including the intended use of chemicals in the pre-registration phase will contribute to the solution of this problem.
· The pre-registration phase should include the ‘intended use’. Downstream users must be allowed to register the use during the pre-registration phase. This would allow the down stream users to assess if their use is covered or not. This would allow for an early and transparent dialogue between the user and the supplier.
· It would help the ‘organic growth’ of information concerning ‘use’ prior to the final registration phase. It would solve several workability issues related to misinterpretations and misunderstanding of "intended use" and thus avoid numerous notifications from users to the agency. It would also allow consortia building of users and sharing of information.
· The pre-registration phase should include an indication of both the volume produced per substance and of the estimated volume per ‘intended use’. This would provide transparency in compliance with point 11(iii) of the regulation for users, producers, importers, the agency and competent authorities.
5.7 Co-operation between users
The proposed regulation text encourages manufacturers and importers to co-operate. There are several special provisions for this purpose.
There are however no provisions for co-operation between ‘end users’. The hundreds of thousands of European ‘manufacturers of articles’ can however efficiently be grouped according to similar production processes such as vehicle refinishing, offset printing, tape manufacture etc.
Within such a group of end users, the problems encountered and the necessary communication with suppliers or the Agency will be similar or even the same for many individual enterprises. It would be far more efficient if simplification through co-operation between end users were possible. Consortia of end users should be possible. Trade associations may fulfil a very useful role.
· The regulation should contain provisions for the efficient co-operation between ‘end users’ or ‘manufacturers of articles’
5.8 Inefficient use of existing knowledge, infrastructure & legislation
The draft regulations rarely encourages or prescribes the use of existing knowledge about chemicals and the use of existing infrastructure that already ensures the safe use of chemicals. The regulation reads as if until now hardly anything has been regulated, where in practice most of the possible unsafe uses of chemicals are already addressed in one way or other. To give a few examples:
· Hundreds of different Member State criteria documents exist. They often are much the same as the EU risk assessment reports, of which indeed only a very limited number exist.
· Harmonised classification & labelling covers already several thousands of the most frequently used substances today. In addition many thousands of substances are self-classified by the producers.
· The Scoel has recommended occupational exposure limits for scores of substances
· European national authorities have done so with hundreds of substances.
· The chemical industry has developed a working method to recommend Occupational Exposure Limits for mixtures of solvents.
· European Scientific Committees have reported on hundreds of substances
· Specific legislation for food contact materials, cosmetics and toys today covers thousands of different substances.
· The European waste catalogue adequately distinguishes between hazardous and non-hazardous waste.
· Several environmental directives cover emissions to the environment adequately.
· WHO, ILO and IARC publish reports on occupational health in certain industries

Almost every part of this enormous existing infrastructure will stay in place. The REACH system will however duplicate most of the work that was already done.
· Making good use of existing knowledge and of the existing infrastructure would greatly increase efficiency, it would avoid double work and reduce cost drastically.
In addition, many product-related directives exist, that adequately regulate the safety of products in general or of specific groups of products.
· There is no need to include possible release of substances from articles in this regulation
5.9 Overly prudent classification and labelling
A large part of the European and Member State legislation regarding the health & safety of workers, the prevention of accidents, the disposal of waste, emissions to air or discharges to water is based upon the classification or labelling of the substances or preparations. The more hazardous the classification, the stricter the rules in force.
Where substances or preparations are classified or labelled more prudently then strictly necessary, this automatically leads to excessive cost for the end-user. The proposed regulation leaves too much room for self-classification that deviates from existing harmonised classification.
· Wherever it exists, the use of harmonised classification or labelling should be compulsory. (Unless this classification or labelling is evidently wrong of course). This will prevent excessive cost for the end-user.
5.10 Exemptions
Very few groups of substances are exempted from the proposed regulation. More use should be made of existing regulations or combinations of regulations that already cover groups of substances adequately.
Substances used as food contact materials are, with regard to migration, well covered by it’s own legislation. Where the consumer is protected, the worker is generally also protected where substances have not been allocated a Specific Migration Limit (SML). The end products are always packaging materials and these are adequately covered by the Packaging and Packaging Waste directive.
· Food contact materials without SML can safely be exempted from the scope of the regulation
To the list of exempted natural products we recommend to add:
· Cellulose
· Alginate
5.11 Timing & Pilot Phase
According to the regulation text, the obligation to make ‘chemical safety assessments’ starts one year after the regulation enters into force. For manufacturers of chemicals this assessment will immediately need to result in a chemical safety report.
Making a ‘chemical safety report’ is expensive. The fact that these reports will need to be made for every single existing chemical, without delay and without lower threshold, nullifies to a large extend the staggered implementation scheme for registration. It will bring forward the much feared ‘deselection’ of chemicals.
· A staggered implementation scheme for making ‘Chemical safety assessments’ and ‘Chemical safety reports’ should be introduced.
Even if the regulation is simplified as proposed in our comments and no doubt in those from other stakeholders, it will continue to have a large impact on industry.
A pilot phase, a thorough review and the possibility to adapt the regulation to the experience built up in the pilot phase, should be included in the regulation.
5.12 Exposure data
Annex 1 stresses the importance of ‘adequately measured and representative exposure data’. The annex does however not describe clearly why these exposure data are so important and what they should be used for.
The regulation itself does not mention the need for exposure data. This is consistent with the logical idea that the exposure scenarios should be based on the assumption that the recommended chemical safety measures are implemented by the user.
· Measured exposure data are not necessary, and if they are available, they should fulfil only a minor role, as the exposure scenarios need to be based upon the recommended chemical safety measures.
Also exposure data are hardly ever ‘adequately measured and representative’. Actual exposure is influenced by existing European or Member State legislation, it is only measured when exceedence of the legal limits is feared, only substances responsible for the highest exposure are measured, measurements are often simplified and measurements lead to exposure reduction.
In spite of this, exposure data can be useful. They must however always be interpreted in the context of their measurement.
· Where exposure data are being used, the context of the measurements needs to be known and reported. This will also reduce the need for ‘adequate measurement’ and representativeness.
5.13 Polymers
Legislation already exists regarding polymers to protect consumers’ health. Thousands of similar but not completely equal polymers exist.
· The inclusion of polymers in the regulation makes the scope extremely wide and the system disproportionately complex, with little added benefit.
5.14 Agency
The structure, workings and decision making procedures of the Agency are not commented upon in general. The issues below are however especially important to the ‘end user’ industries.
The Agency will liaise with industry through the ‘forum’. This is not enough. For trade associations of end user industries it should also be possible to liaise directly with the secretariat, the committees and the working groups.
The ‘end users’ or ‘manufacturers of articles’ should be represented on the Management Board. At least one of the nominations by the Commission should be reserved for this important and extremely large and diverse part of European industry.