Stakeholders Reactions - European Commissionec.europa.eu/environment/chemicals/reach/background/docs/...Stakeholders Reactions 24/07/2003 *****121677 Organisation Industry AT - Austria

Stakeholders Reactions 24/07/2003

Stakeholders Reactions

121215**********Organisation Industry AT - AustriaType: Category: Country:

Chemical safety assessment - Efficiency of ProceduresTopic:

Chemical safety assessment - Efficiency of Procedures: Please enter your general comments

das sicherheitsdatenblatt muss unbedingt eine zentrale rolle beibehalten!die downstream user - in unserem fall hauptsächlich handwerker - sind mit der datenfülle völlig überfordert.

Downstream Users - Efficiency of ProceduresTopic:

Downstream Users - Efficiency of Procedures : Please enter your general comments

die downstream user - in unserem fall hauptsächlich handwerker- sind mit der datenfülle völlig überfordert.

Registration Procedure - Efficiency of ProceduresTopic:

Registration Procedure - Efficiency of Procedures: Please enter your general comments

der bürokratische aufwand ist in der praxis undurchführbar.

die agency scheint mehr verwaltungsbehörde als dienstleister zu sein!

The Agency - Efficiency of ProceduresTopic:

The Agency - Efficiency of Procedures: Please enter your general comments

die agency scheint mehr verwaltungsbehörde denn dienstleister zu sein!

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siehe Mail vom 3.7.2003 an [email protected]

Downstream Users - OtherTopic:

Downstream Users - Other: Please enter your general comments


Downstream Users - Scientific and technical soundnessTopic:

Downstream Users - Scientific and technical soundness: Please enter your general comments


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mailto:[email protected]:[email protected]:[email protected]





The procedure is unacceptable for our company. We a very concernd to get all of our raw-materials for the future. As we are a midsize-company, it is veryimportant to keep our niche-products. But how will supply us with the right chemicals?

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Die geforderten Downstream User Chemical Safety Assessments müssen für Zubereitungen als Ganzes, nicht aber als Summe von Rohstoffreportsdurchgeführt werden. Die Downstream User Chemical Safety Assessments brauchen Abschneidegrenzen, wie sie in der Zubereitungsrichtlinie definiert sind,damit nicht mit hohem Aufwand Spuren von Stoffen durch die gesamte Lieferkette verfolgt und nachgewiesen werden müssen. Diese Information ist imZweifelsfall völlig sinnlos.



Schon heute werden den Kunden sehr umfangreiche Daten und Verhaltenshinweise für den sicheren Umgang mit den Lacken und Farben zur Verfügunggestellt.In diese Unterlagen (Sicherheitsdatenblatt, technisches Merkblatt) fließen die Risikopotentiale der Rohstoffe mit ein.

Die Chemical Safety Reports sind völlig ungeeignet, um den Kunden eine sichere Handhabung der Zubereitungen zu ermöglichen. Die Weitergabe vonInformationen in 11 bzw. demnächst 18 Amtssprachen ist absolut sinnlos. Eine Übersetzung jedes Dokumentes in jede Sprache ist wegen der schierenAnzahl nicht durchführbar. Für den täglichen Gebrauch und die sichere Handhabung ist ein Kurzdokument mit konkreten Anweisungen notwendig. Dies istgegenwärtig in Form der R- und S-Sätze in den Sicherheitsdatenblättern gewährleistet. Das Sicherheitsdatenblatt ist somit die geeignete Form, in möglichstkurzer Form und in den jeweiligen Landessprachen ein Risikomanagement zu ermöglichen.

Information Flow - Efficiency of ProceduresTopic:

Information Flow - Efficiency of Procedures: Please enter your general comments

Die Weitergabe von Informationen an die nachgelagerten Stufen der Lieferkette in Form von Chemical Safety Reports muss handhabbar bleiben. Es mussÜbergangsfristen geben, da sonst unmittelbar nach Inkrafttreten der neuen Chemikaliengesetzgebung im Grunde genommen alle Zubereitungen bearbeitetwerden müssen.

Beispiel: 1300 Rezepturen mit durchschnittlich 7 Komponenten ergibt 9100 Chemical Safety Reports.

Derzeit ist in unserer Firma nur eine Person qualifiziert diese Arbeit zu verrichten.Es müssen entweder bereits beschäftigte Mitarbeiter intensiv geschult werden, oder neue Mitarbeiter rekrutiert werden. Beide Massnahmen sind sehr zeit-bzw. kostenintensiv.

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OtherTopic:

Other - Please enter your general comments

The problem will be that many varnish raw materials due to the profitability of the market will disappear and there are not any alternatives. Therefore, many ofour products will not be delivered in the desired quality standard or may not even be delivered at all any more.

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In accordance with the legislation in the field of occupational health and safety (OHS) and safety for installations, the CSA should be limited to the actual (orintended) use of a substance or a preparation with a certain exposure category. The safety data sheet (SDS) for a substance or a preparation shall serve asthe basis for the risk assessment.The use of exposure categories markedly simplify the CSA especially for down stream users (DUs).

Data requirements - Efficiency of ProceduresTopic:

Data requirements - Efficiency of Procedures: Please enter your general comments

Since the different data requirements are set on the basis of quantity only, the waiving on the delivery of data (performing of tests) on the basis of risk(impossible exposure for certain intended uses) must be facilitated markedly, especially for low volume substances (< 100 t/a).

Especially for low volume substances (< 100 t/a) the use of a base data set as laid down in the voluntary commitment of VCI, which was taken over by theAustrian chemical industry, must be sufficient, if these substances do not exhibit a high risk. It will also be essential, also as a reward to those companies,which participated at this voluntary agreement, that these data gained by the VCI initiative or ICCA initiative, will be accepted in accordance with Annex IX,without further justification.

The application of Annex IX in the use of existing data will also be crucial for the avoidance of unnecessary animal testing. The same counts for acceptanceof the results of the structure-activity relationship (SAR, QSAR). In terms of minimising animal test it is not understandable, why for those substances, wherethese models predict negative dangerous properties (on a substantiated basis along with the practical experience), ¿the relevant tests shall nevertheless beperformed.¿



¿ The content of the information up and down the supply chain must be limited to the minimum necessary to obtain the maximum information, in order to getthe acceptance of SMEs. The tool of this information chain shall be the safety data sheet with some additional information concerning risk assessment andrisk management, if necessary.¿ The information for preparations shall not give a detail analysis for all the substances in this preparation, since this will overload the information system.Apart from the overwhelming administrative burden the inherent properties of all substances in a preparation will in most of the cases not adequately reflectthe risk connected with the preparation. Therefore, the information flow shall rely on the SDS as a basis.¿ The confidentiality of information passed along the supply chain must be secured properly.¿ On the basis of a simple risk assessment based on exposure categories in coherence with the current requirements will be able to manage the risksproperly. An information to the agency is not necessary from our point of view



SMEs will not be able to administer the intended information overflow, neither in terms of workload nor in terms of expertise.In addition, the information flow for all the ingredients in a preparation (regardless of their concentration) will not protect confidential business informationappropriately.Thus, the information requirement ¿ up and down the supply chain ¿ shall be restricted to the SDS for a substance or a preparation.



To keep the registration requirements to a minimum, all available data required by existing EC law should already be accounted for and, thus, exempted forthe registration.

Additionally, the information requirements for the registration of substances contain a lot of duplication need to be simplified in order to keep theadministrative burden for the industry to a minimum. A suitable way will be the use of the SDS as the registration tool along with the quantitative information(production or import) and the information on risk management measures in line with appropriate exposure categories.

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Chemical safety assessment - OtherTopic:

Chemical safety assessment - Other: Please enter your general comments

In accordance with the legislation in the field of occupational health and safety (OHS) and safety for installations, the CSA should be limited to the actual (orintended) use of a substance or a preparation with a certain exposure category. The safety data sheet (SDS) for a substance or a preparation shall serve asthe basis for the risk assessment.

The assessment of single substances in preparations on the basis of the chemical safety report (CSR) is not feasible - especially for down stream users(predominantly SMEs) - in terms of workload and proper expertise. Furthermore the assessment of single substances will ¿ in most of the cases - not reflectthe proper risk of a preparation and, thus, might result in the wrong safety management measures.

Data requirements - OtherTopic:

Data requirements - Other: Please enter your general comments

Since the different data requirements are set on the basis of quantity only, the waiving on the delivery of data (performing of tests) on the basis of risk(impossible exposure for certain intended uses) must be facilitated markedly, especially for low volume substances (< 100 t/a).

Especially for low volume substances (< 100 t/a) the use of a base data set as laid down in the voluntary commitment of VCI, which was taken over by theAustrian chemical industry, must be sufficient, if these substances do not exhibit a high risk. It will also be essential, also as a reward to those companies,which participated at this voluntary agreement, that these data gained by the VCI initiative or ICCA initiative, will be accepted in accordance with Annex IX,without further justification.

The application of Annex IX in the use of existing data will also be crucial for the avoidance of unnecessary animal testing. The same counts for acceptanceof the results of the structure-activity relationship (SAR, QSAR). In terms of minimising animal test it is not understandable, why for those substances, wherethese models predict negative dangerous properties (on a substantiated basis along with the practical experience), ¿the relevant tests shall nevertheless beperformed.¿



Although we welcome the stronger involvement of down stream users, especially professional end users, in chemicals management, the necessaryinvolvement of DU in the various steps needs to take into account the resources and expertise, since they are predominately SMEs. In this respect, we wantto highlight the necessary changes, for the duty of care, chemical safety assessment and information flow, once again.

¿ A tiered approach for the duty of care, depending of the involvement of the DU in chemicals management (formulator, end user), needs to be incorporated.¿ The content of the information up and down the supply chain must be limited to the minimum necessary to obtain the maximum information, in order to getthe acceptance of SMEs. The tool of this information chain shall be the safety data sheet with some additional information concerning risk assessment andrisk management, if necessary.¿ The information for preparations shall not give a detail analysis for all the substances in this preparation, since this will overload the information system.Apart from the overwhelming administrative burden the inherent properties of all substances in a preparation will in most of the cases not adequately reflectthe risk connected with the preparation. Therefore, the information flow shall rely on the SDS as a basis, as mentioned before.¿ The confidentiality of information passed along the supply chain must be secured properly.¿ On the basis of a simple risk assessment based on exposure categories in coherence with the current requirements for OHS, DUs will be able to managethe risks properly. Different risk management measures shall be communicated to the supplier. However, an information to the agency is not necessary fromour point of view.

Evaluation procedure - OtherTopic:

Evaluation procedure - Other: Please enter your general comments

In order to have a harmonised approach in the evaluation procedure, the evaluation of the data should be performed by the central agency. This will enhancethe efficiency of this process and give rise to legal certainty. The member states can be involved in the review process of these evaluations.

The priority evaluation by member state authorities will overburden the system (Evaluation for substances below 1t/a is contradictory to the objectives set outin the White Paper) and, additionally, give rise to legal uncertainty.

Information flow - OtherTopic:

Information flow - Other: Please enter your general comments

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As the current text reads now, the information flow contains a number substance related dossiers (i.e. CSR), which will have to be communicated up andown the supply chain, irrespective of the risk (dangerous property, relevant concentration and actual exposure) implied with an intended use.

This will create an over-boarding burden for DUs (manufacturers/importers of preparations and end users) to handle the required information flow, especiallyif one considers that this substance based information will have to be established in different languages (up to 20 within the EU). SMEs will not be able toadminister such an information overflow, neither in terms of workload nor in terms of expertise (e.g. a carpenter, who uses a paint; a hairdresser, who uses ashampoo; a farmer, who uses a plant protection product).

Furthermore a substance related information for all the ingredients in a preparation might be in contrast to the relevant risk of the preparation, which iscommunicated with the SDS.

In addition, the information flow for all the ingredients in a preparation (regardless of their concentration) will not protect confidential business informationappropriately.

Thus, the information requirement ¿ up and down the supply chain ¿ shall be restricted to the SDS for a substance or a preparation, eventuallysupplemented with suggested risk management measures for this substance and preparation obtained in accordance with existing EU law (OHS; Sevesodirective).

Registration Procedure - OtherTopic:

Registration Procedure - Other: Please enter your general comments

To keep the registration requirements to a minimum, all available data required by existing EC law (or international initiatives; e.g. OECD; ICCA-HPV) shouldalready be accounted for and, thus, exempted for the registration.

Additionally, the information requirements for the registration of substances contain a lot of duplication (i.e. summary of information derived from Annexes Vto XI, Robust study summary; Chemical safety report), need to be simplified in order to keep the administrative burden for the industry as well as for theauthorities (Agency and member states) to a minimum. A suitable way will be the use of the SDS as the registration tool along with the quantitativeinformation (production or import) and the information on risk management measures in line with appropriate exposure categories.

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Ich bin nicht sicher, wie man den Informationsfluss der gesetgebung bis zum Verarbeiter bringen soll ohne wahnsinnigen bürokratischen Aufwand zu treiben.Die Einschrenkung von Rohstoffen werden den aktiven Schutz unserer Kulturbauten gefährden und somit der nachwelt nicht in dem Zustand erhaltenwerden können.Die Hygiene wird auch von Anstrichmittel stark beeinflußt. Ich fürchte durch verzicht auf Rohstoffe wird die Industrie die verschleissfesten und Anstrichmittelmit besonderen Eigenschaften nicht mehr herstellen können.Ich bin sicher, dass das Konzept der wichtigen Regelungen in der Chemikalienpolitik nicht ganzheitlich bearbeitet wurde sondern nur von einer Seite und dinicht von der Praxis und den Bedürfnissen der Oberflächen.**********

Registration Procedure - Scientific and technical soundnessTopic:

Registration Procedure - Scientific and technical soundness: Please enter your general comments

Der Aufwan intern und die zusatzkosten können von den Unternehmungen in Europa nicht mehr ausgeglichen werden. internationaler Druck wird dazuführen, das Ausländische Erzeugnisse und Produktionsstädten mit anderen Kostestrukturen den inländischen Markt unterbieten werden.Es besteht also Gefahr für Abeitsplätze, Bertirebsstandorte und traditionelle Anbieter.

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121434Donau Chemie AGOrganisation Industry AT - AustriaType: Category: Country:

Data requirements - Efficiency of ProceduresTopic:

Data requirements - Efficiency of Procedures: Please enter your general comments

We don't understand, why we have to register substances like hydrochloric acid or sulfuric acid, which are amongst the most common and most importantsubstances that are produced and used in industry. Even by participating in a consortium extensive bureaucratic data have to be submitted. Furthermore, it isnot workable to assess 90% of the use of the substances, since there are probably more than 100 uses of a product like sulfuric acid, many of them far downthe supply chain, especially taking into account the many uses in preparations.

We also see lots of duplication in data. Why is there an obligation to register all the information on data of the annexes IV to VIII in addition to the safetyreport, which already contains and assesses all relevant information in regard to the safe use of a substance?

It is in our company policy to protect the environment and to minimize risk for the human health of our employees and customers. Our measures to protecthuman health exceed the legal requirements. We offer training for our customers how to handle toxic and corrosive substances. We work together with localauthorities to evaluate the exposure risks to our substances at work places. We transport dangerous chemicals under the regulations, which are effective inthe field of transporting dangerous goods. We already suffer from extensive regulations, and if more bureaucratic burden is loaded on our shoulders, thismay create a downward spiral (as predicted in several studies carried out all over Europe): We have to increase the prices for our substances. The industrycompeting on the global market cannot tolerate these increased costs, thus transferring production outside the EU. Less production within the EU meanshigher costs for the remaining production, thus creating more potential for importing goods from outside the EU ¿¿.

Therefore we strongly ask the commission to rethink the draft, and consider that environmental protection and human health protection must and can beaccomplished with far less bureaucracy.



We are a small, local producer of basic chemicals, that are substancial for a wide range of industrial manufacturing in the chemical industry as well as inindustries like petrochemistry, electronics and electrical industry, paper production and food industry. Our products are HPV Chemicals, which have alreadyundergone extensive evaluation within programmes like OECD HPV Chemicals Programme or EU Existing Substances Regulation. In our opinion, there isno need to register substances, which are well documented and the information is already available to the authorities.

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121435Donau Chemie AG Organisation Industry AT - AustriaType: Category: Country:



We produce fertilizers in large quantities, therefore enourmous amounts of information has to be provided, although the substances, that our fertilizersconsist of, are well known, for instance potassium phosphates, potassium sulfate, calcium phosphate and ammonium phosphates. The downstream usersurely will not read the provided information about the compounds a fertilizer is made of. It is in our opinion sufficient to give short an clear instructions aboutthe intended use, especially how the fertilizers are to be applied, and about safety and first-aid measures in case of accidents. This information needs totransferred to the user by writing on the packaging. In addition we prefer to use the existing safety data sheets, which also gives information about precautionfor storage or measures how to react in case of fire in a warehouse. This essential information can be handled by the agricultural industry. But it has to beconsidered, that also in many cases the end-user of a fertilizer is a small farmer. It is totally out of proportion and superfluos to provide toxicity studies to asmall farmer, whose main concern is, how to survive in the competitive agricultural market.

In addition, we sell our fertilizers in countries like Czech Republic, Slovakia, Hungary, Poland, and Slovenia. The work, that has to be put into translation of allthe required information does not make sense, knowing that it is impossible to bring this information to the end-user, being familiar with the structure ofagricultural industry in the new member states.

We suggest, that fertilizers are exempted from the new chemical regulation or that it does not apply to the farming industry.



Registration does not exempt fertilizers, although fertilizers are already undergoing the process of registration in accordance with the fertilzer-regulationswithin the member states.

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121436Donauchem Handelsges.m.b.H.Organisation Industry AT - AustriaType: Category: Country:

Information flow - Scientific and technical soundnessTopic:

Information flow - Scientific and technical soundness: Please enter your general comments

We produce liquid fertilizers for the Central European market. The intended use of these fertilizers is mainly the private consumer, but until the productreaches the market, it is handled down a supply-chain. Yet, there is a small segment of professional users in the gardening industry. Therefore it seems to benecessary to provide the members in the supply-chain with a huge amount of information, which is totally superfluous.

In addition, if the view of production is considered, what information has to be provided? The production our liquid fertilizers varies on the availability and onthe prices of raw materials. To illustrate this, take into consideration, that one batch is produced of dissolving ammonium nitrate, a highly oxidizing agent,forming explosives with organic matter, and the next batch is produced by neutralizing nitric acid with ammonium hydroxide solution, both chemicals knownto be extremely corrosive. Non of the above mentioned dangerous properties of the raw materials appear in the product. Why then carry this information toemployees of a gardener or of a gardening market. Within this intended use supply-chain it is impossible to separate the ingredients of a liquid fertilizer, sothat the orignal dangerous properties of the compounds, such as corrosiveness, or oxidizing potential, reappear.

Therefore, the process of information down the supply-chain has to be reworked to satisfy the need of information for everyone involved from production tothe user, but not overload the involved parties with data, they don't need and that cannot be processed.



Registration does not exempt fertilizers, although fertilizers are already undergoing the process of registration in accordance with the fertilizer-regulationswithin the member states.

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121437Donauchem Handelsges.m.b.H.Organisation Industry AT - AustriaType: Category: Country:

Chemical safety assessment - Scientific and technical soundnessTopic:

Chemical safety assessment - Scientific and technical soundness: Please enter your general comments

We are a producer of various surface treating and cleaning agents. We formulate over 100 complex mixtures, most of them consisting of 5 to 10 differentchemical substances, several even being made of up to fifteen ingredients. Most of our products are developed individiually for only one or a few customerswith very special applications.

We try to give the best possible information on the dangerous properties and on safe usage of our formulations to our customers, but we are deeplyconcerned about the amounts of information we have to assemble for each individual formulation we place on the market. Our customers, often belonging tothe segment of SME, will not be able to handle the information provided through up to 15 chemical safety reports for one product.

Our formulations often contain ingredients, that are corrosive, flammable or oxidizing, when used by itself. But within the formulation the ingredients muchlikely loose their dangerous property. For example, consider an aqueous mixture of several acids, such as phosphoric acid, citric acid and oxalic acid withsodium and/or potassium hydroxide yielding a neutral cleaning product. The product also may contain a chemical, that is flammable, like alcohol, and/oranother one that is oxidizing.

We think, that by providing the downstream user with all the information to the individual chemicals, we will create more unsecurity, and as a result, build upresistance to even read the information provided. What really matters, is a sound accurate safety data sheet that points out the dangers of the mixture. Itsurely is valuable, that the down stream user is informed about the dangerous ingredients, as it is state of the art anyway. The information in the SDS mustenable the user to identify the risks involved in his application and take the measures to protect the exposed employees and the environment. We stronglyfavour a regulation that puts strict emphasis on point 7 in the SDS, which is substancial for human health protection, but we oppose a regulation, thatrequires information leading to the opposit, especially making the user uncertain about the real risks of a product by pointing out data, that do not representthe risk of the product. The commission has to consider, that the end user of a complex mixture is usually not in the chemical industry and has no or fewresources to evaluate the risks and measures taken against the risks of using chemicals. The user needs to trust the given information. We can reach thisgoal by producing sound and accurate SDS, but not with information overflow.



Confidentiality - InnovationSince we are producing mixtures for niche applications, it is essential that our innovations are kept confidential. Under the new regulation it will be mandatoryto name all ingredients of a formulation by handing down chemical safety reports. Our main thrive of innovation consists of the development of new mixturesacting in an industrial process as well as or even better, but with the usage of less toxic, less flammable or less corrosive chemicals. If we have to publish ourknowledge by supplying CSR for each chemical, even the harmless, in a formulation, this business branch is under threat of closing down. Thus, REACHagain reaches the opposite of its intention: It will eliminate the innovation of finding safer substances for safer use.

Therefore we strongly recommend the use of the well established SDS as source of information for the downstream user. It is clear to the industry withchemical knowledge, that a substance may act different in dependence of its concentraton in a formulation and of the formulation itself.

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121410Dr. Zimmermann GmbH & Co, AustriaOrganisation Industry AT - AustriaType: Category: Country:



PLease keep it as simple as to allow a normal, non-specialized engineer to apply the procedures !

Duty of care - Efficiency of ProceduresTopic:

Duty of care - Efficiency of Procedures : Please enter your general comments







Please impose no registration costs ! Keep the necessary bureaucratic investment as low as that it may be covered by the taxes already paid by theconcerned companies !

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121745Feycolor GmbHOrganisation Industry AT - AustriaType: Category: Country:

OtherTopic:


Als kleines Industrieunternehmen sind wir auf Nischenprodukte angewiesen um im Markt bestehen zu können. Wir befürchten, dass uns dann aufgrund derPrüfungskosten (Rohstoffe)unsere bewährten aber sonst selten verwendeten Rohstoffe nicht mehr zu erhalten sind.

Other - Please enter your proposed change to the legal text starting with reference of article, paragraph or annex (if youhave no proposed changes, please leave blank)

Rohstoffe sollten immer erhaltbar sein.

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121874Fries Burgholzer &Co BaustoffindustrieOrganisation Industry AT - AustriaType: Category: Country:

Chemical safety assessment - OtherTopic:

Chemical safety assessment - Other: Please enter your general comments

2. Chemical safety assessment

Fries Burgholzer is a typical downstream user. We offer safety data sheets to all our customers of all our products as well in a printed form as to bedownloaded from our home page. Instructions to a secure handling to avoid damages concerning health or environmental damages are given as well in ourtechnical informations as on our product labels.

To produce CSA for all our formulations and to manage all CSA we will receive from our suppliers as suggested would mean that we have to increase ourstaff in this area from one people now to about five or six in the future. In the average our customers got less than 10 employees and no one of them everwould read CSA of products consisting of up to 20 components with 20 CSR each 20 pages and more.We are working in the highly competitive market of exthernal thermal insulation systems, in which we are the biggest player in Austria.In our market we andall of our competitors are trying to increase our market share, what leads to decreasing prices of all our products.Our products are no high tech formulations and of relatively low price.Our raw materials mostly are very low price products which we try to buy from producers within short distance from our production facility. Thesemaunfacturers usually are very small companys who surely can not efford additional costs on their products. We think that the biggest winners of this REACHproposal would be big multinational companies, winning market shares from small manufacturers.The current economic situation in Austria and in the EU does not allow to waste money or to increase selling prices. Besides this the secrecy of ourformulations would not be guaranteed if everybody gets the composition.

So our proposal is to extend the safety data sheet with some additional requirements to one CSA with 10 pages maximum sufficient for a single product. Sowe all can make sure that all the informations given in this report will be red and taken notice of.

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122008Hueck-FolienOrganisation Industry AT - AustriaType: Category: Country:

Evaluation procedure - Efficiency of ProceduresTopic:

Evaluation procedure - Efficiency of Procedures: Please enter your general comments

In my opinioun the evaluation procedure of all used chemicals and substances by REACH-System are to overdrawn with no guarantee to improve theeuropean chemistry policy, especially to protect the environmental and humanity.Hueck-Folien as an downstream user depends on niches products and also from many different chemicals. For survivable of small and middle enterprises isthe question of price of chemicals very important. The evaluation procedure for suppliers leads only to an unwilling increase in prices of chemicals and not inbetter conditions for the environment and mankind.The consist regimentations of chemicals in the area of industry-work safety and environmetal safety are quite good and sufficient controlled throughproducing, transportation and processsing from chemical substances.In terms for humans and environmental no additional benefit is discernebly with these complex evaluation.

Yours sincerely

Dr. Jürgen Keplinger

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121654SYNTHESA Chemie Gesellschaft m.b.H.Organisation Industry AT - AustriaType: Category: Country:



The SYNTHESA-Group is a typical downstream user. As mentioned above we offer safety data sheets to all our customers of all our products as well in aprinted form as to be downloaded from our home page. Instructions to a secure handling to avoid damages concerning health or environmental damages aregiven as well in our technical informations as on our product labels.

To produce CSA for all our formulations and to manage all CSA we will receive from our suppliers as suggested would mean that we have to increase ourstaff in this area from two people now to about seven or eight in the future. In the average our customers got less than 10 employees and no one of themever would read CSA of products consisting of up to 20 components with 20 CSR each 20 pages and more. So please make an easy calculation: 1000products, each consisting of 15 components in the average and 9000 customers. So a lot of paper would be produced without any sense. Our products areno high tech formulations and of relatively low price. The current economic situation in Austria and in the EU does not allow to waste money or to increaseselling prices. Besides this the secrecy of our formulations would not be guaranteed if everybody gets the composition.

Chemical safety assessment - Efficiency of Procedures: Please enter your proposed change to the legal text starting withreference of article, paragraph or annex (if you have no proposed changes, please leave blank)


Duty of care - OtherTopic:

Duty of care - Other: Please enter your general comments

The SYNTHESA-Group consists of three companies, SYNTHESA Chemie Gesellschaft m.b.H., Fries, Burgholzer & Comp. Baustoffindustrie Ges.m.b.H.(Capatect) and Glemadur Farben und Lacke Vertriebsges.m.b.H. as trading company, is the greatest manufacturer and dealer of paints and varnishes, woodprotection agents, glues and adhesives in Austria with two production facilities, 9 sales offices and about 500 employees spread over the country. More than800 raw materials usually pre-mixed formulations are required to produce and offer about 1000 different preparations (except all the various possible colours)to be delivered to more than 9000 customers in Austria and neighbouring countries. More than 90 percent by weight of our formulations are water based andnon hazardous materials. Only a few amount of our production is classified as hazardous and is delivered to industrial plants mainly. Already all ourprofessional customers get a safety data sheet according to 91/155 EWG of each product even hazardous or not. Safety data sheets are also available onour home page.

The SYNTHESA-Group declares to agree to the intents of this proposal but we have to make a number of severe critical comments.



Nearly all the same arguments as mentioned above could be named in this item. Each of our customers gets up to 10 products in the average and probablynone of them will give us any feedback because of his own personal situation. Quit the contrary we are in permanent contact with our suppliers to get betterraw materials and especially less hazardous.

Information Flow - Efficiency of Procedures: Please enter your proposed change to the legal text starting with referenceof article, paragraph or annex (if you have no proposed changes, please leave blank)




Page 18 of 1395


We support the intent to use toxicologically and ecologically tested materials. But note, the suggested procedure is, due to the bureaucratic requirementsnecessary, impossible to be realised in an economic manner.

As a downstream user who does not manufacture any raw materials but only mixes them we are not in a position to bear all costs necessary to register onlyone material. Even our suppliers are not able to bear the costs for all materials they offer nor it is possible to pass on these cost to their customers to us. Sowe are in accordance to the opinion of the Fachverband of the Austrian chemical industry and the German industry that estimated up to 50 % of all rawmaterials will not be longer available in the future if this regulation is installed as proposed.

The effect of loss of such a number of raw materials is dramatic. Neither the number of finalized products nor the quality could be maintained. So in theconsequence we expect that a lot of companies especially smaller ones have to stop their production as well as raw material producers as downstreamusers. Many consumers of all these products we offer also have to finish their activities. As a further consequence the European chemical industry and allthose companies depending on it will loose competitivity compared with countries outside the EU and thousands of employees in Europe will loose their jobs.

This can not be the object of an European parliament with sense of duty. So we request to prolong the dialogue with all concerned organizations to find acompromise suitable to the intentions of the proposal as well as to economic realizability.

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122069Vialit Asphalt GmbH & Co. KGOrganisation Industry AT - AustriaType: Category: Country:

OtherTopic:


We are producer of road construction products.

We know, that the REACH-System as it is planned, will cause many vital problems for us and other SMEs like us.We use many raw materials that are usually not used in the asphalt-industry, so we would have to register them.Many of our products contain a lot of know how and the REACH-system would force us to give all our formulation details and know how to our customers.Since these customers are also located outside the EU, it would be easy for them to find producers outside the EU which are cheaper and with lessbureaucracy.For many of our products we need raw materials which are very specialised and therefore not easily available. These raw materials could disappear from theEuropean market, because of REACH and importing them would necessitate the engagement of specialised personnel, which is hard to get and even harderto afford.Since our company depends on these special products - because of a very fierce competition in the construction industry - to remove them from our range ofproducts would bankrupt our company.

Considering all of the above the REACH-system as it is planned now, will be a real danger to our company and to other SMEs like us, especially those withniche products.

Most of our niche products are environment friendly products replacing such products containing solvents. We DO care for the environment, yours and ourhealth, but our environment friendly alternatives will have no chance against large scale produced standard products in the future you are planning for us.

Please help us to find a way where environment protection, pollution control, economic efficiency and fair competition come together.

Yours faithfullyIng. Simone LenhardVialit Asphalt

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119966**********Organisation Industry BE - BelgiumType: Category: Country:

OtherTopic:


As a polyurethane processor, we buy chemicals and pre-polymers from big companies as Bayer, ... etc. We manufacture wheels with a polyurethane tyreand technical parts (sheets, rots, elastic couplings, ¿) in polyurethane.

In our opinion, the inclusion of polyurethane polymers leads, to a huge burden on our industry, and at the same time to an overload of the REACH processon the part of the authorities.

The benefit seems very low, since polymers by their very nature do not generally pose any hazards for humans or the environment.The pre-polymers we are using have a low hazard potential. We take already into account the legally regulated measures of protection for humans and theenvironment.Consequently, additional registration of polymers of this type would not achieve any significant improvement in safety.

The costs, however, would be very high for a small company like ours. For the moment it is not clear to us if polyurethane elastomers will be exempted fromcompulsory registration as they are produced from chemical reactions from other (pre-)polymers or non-polymeric substances in an end application (e.g.coating on a metal core). But even drawing up a ¿chemical safety report¿ will be a huge burden for our small company.We are also afraid that the high registration costs will affect the cost prices of the specialty pre-polymers an substances we are actually buying.

********** therefore wants polyurethane polymers generally to be removed from REACH if their starting substances are registered by the chemical companiesthat sell them.

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122110**********Organisation Industry BE - BelgiumType: Category: Country:

OtherTopic:


In the name of **********, I would like to report that we have read the comments prepared and submitted by the European Chemical Federation CEFIC and bythe Belgian Chemical Federation Fedichem. We wish to support their concerns and insist that strong consideration be given to the issues raised by thesefederations. Please therefore refer to the solutions and amendments proposed by CEFIC and by Fedichem.

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121066Devan Chemicals NVOrganisation Industry BE - BelgiumType: Category: Country:

Data requirements - Scientific and technical soundnessTopic:

Data requirements - Scientific and technical soundness: Please enter your general comments

data should be provided in function of the real end-use and exposure.To reduce the risk analysis and the chemical safety reportTo use the safety data sheet as principal communication means

Intermediates - Efficiency of ProceduresTopic:

Intermediates - Efficiency of Procedures: Please enter your general comments

Should not be of application for intermediates

OtherTopic:


The economical impact of REACH will be disastrous for the European economy. We will lose most of our competivity.

The textile industry will for instance migrate out of Europe in order to let the fabrics being treated with unregistred chemicals outside of Europe and so toavoid all the costs of registration. This is the death of the textile finishing business in Europe.

There is not enough labs to check all substances.

The Agency should define pricing of lab analysis in order to avoid that labs abuse of the bottleneck situation. We have a very bad experience with labs for theregistration of biocides. GLP means prices multiplied by 10!!!!

Polymers - Efficiency of ProceduresTopic:

Polymers - Efficiency of Procedures: Please enter your general comments

Should not be concerned



intermediates and polymers should not be concerned



The Agency should have to take more responsabilities

Page 25 of 1395


121898ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals)Organisation Industry BE - BelgiumType: Category: Country:



Established in 1978, as a scientific, non-profit making association to provide a forum to address human and environmental risks of chemicals, ECETOC(www.ecetoc.org) supports the broad objectives of the Commission¿s White Paper.

ECETOC considers that the REACH proposal will neither meet its objectives nor is workable. Specifically it fails to adequately include considerations ofexposure into the requirements for the acquisition of hazard data, irrespective of potential risk. This neither respects considerations of animal welfare norresource allocation and prioritization.

ECETOC has been working with stakeholders over the past 18 months and is developing a tiered, exposure-driven approach to assess the risks presentedby the production and use of chemicals. Details of this approach can be found at (www.ecetoc.org).

Using the ECETOC approach will not only contribute to meeting the requirements for a ¿Safety Report¿ under REACH, but will also allow the integration ofexposure and hazard to identify the information requirements, including further testing if deemed necessary. Our approach will confine the use of animalsonly to those endpoints that are essential for decision-making. It also enables stakeholders to focus resources on those chemicals that are the highestpriority.

ECETOC is keen to work with the Commission and other stakeholders to secure the development of a workable, risk-based framework for meeting thechallenges of REACH in a scientific, efficient and expeditious manner.

Page 26 of 1395

http://www.ecetoc.org)http://www.ecetoc.org).


120875European Fibres Association (CIRFS)Organisation Industry BE - BelgiumType: Category: Country:

Authorisation procedures - Scientific and technical soundnessTopic:

Authorisation procedures - Scientific and technical soundness: Please enter your general comments

We consider incorporation of endocrine disruption in the authorisation process not justified. We consider possible effects of endocrine disruption adequatelycovered by the authorisation for CMR class 1 and 2.



We consider the handling of chemical safety reports by downstream users to be unpractical, and we recommend this to be handled exclusively byproducers/importers.

OtherTopic:


1. We consider the registration of chemicals causing environmental harm released from articles to be unpractical. The reason is that science based rules toverify harmful effects are missing and the very short lifetime of articles like textile and fibres make it impossible to handle investigations and documents in apractical way.

2. Because of the huge danger by the REACH process speciality chemicals used as auxiliaries in fibres and textile business to be withdrawn from themarket (a cost impact on low tonage speciality chemicals), we recommend to increase the threshold quantities defined for registration.

3. Because of the huge uncertainty of the REACH impact on the fibres and textiles industry, refering to the aspects of withdrawal of specialty chemicals andthe possbile huge cost increase and a possibly erosion of European customer base, we recommend to introduce after implementation of REACH within for afew years a pilot face including an impact study on the effects resulting.

Polymers - Efficiency of ProceduresTopic:

Polymers - Efficiency of Procedures: Please enter your general comments

We recommend the general exclusion of polymers from the REACH process. The reason is that polymers generally are of non respectively lowenvironmental concern and the complexity of formulations do not allow a satisfying handling in the context of REACH

Polymers - Scientific and technical soundnessTopic:

Polymers - Scientific and technical soundness: Please enter your general comments

We recommend to complete the annex of natural based products to be exempted from REACH by cellulose and alginate.

Page 27 of 1395


121798European Plastics Converters (EuPC)Organisation Industry BE - BelgiumType: Category: Country:



1. EuPC is concerned at the burden of documentation which must be generated, communicated -and preserved.It is clear that the elaborated CSR as detailed in annexe 11 of the draft regulation imposes obligations which not only create double work in many cases, butwill also be very costly for DU.

THE EXTENT OF THESE OBLIGATIONS SHOULD THEREFORE BE RECONSIDERED TAKING INTO ACCOUNT THE SMALL-AND-MEDIUM SIZE OFMOST DU.

2. Moreover, the list of information to be communicated by all actors in the supply chain is very extensive and even redundant (the safety data sheet alreadycomprising the information). Together with other organisations, we agree that such redundancies can only add to the bureaucracy and may be a source ofinconsistencies between different documents containing similar information. This would result in an overflow of information and possible misunderstanding bythe receiver.

Data Sharing - OtherTopic:

Data Sharing - Other: Please enter your general comments

Title V of the draft regulation on data protection only concerns sharing of information between registrants and not with DU. We are also concerned thatconverters as DU have full access to the data held on particular chemicals by upstream companies. There is indeed a potential risk that, without properregulation, the companies who possess the results of tests might authorise access to them in a ¿selective way¿, and would also set their own conditions fordisclosure. It is self-evident that ¿free¿ negotiations are liable to favour dominant positions in the market, very much to the disadvantage of SME¿s, whichrepresent the weaker element in the market.

ON THE BASIS OF THESE CONSIDERATIONS, EUPC BELIEVES THAT PRODUCERS OF SUBSTANCES, AS OWNERS OF THE DATA TESTRESULTS SHOULD MAKE THESE TESTS AVAILABLE TO USERS, AND THAT THE DRAFT OF THE COMMISSION SHOULD INCLUDE A SPECIFICFRAMEWORK REGULATING THIS SHARING OF DATA AND COSTS BETWEEN PRODUCERS AND USERS, LIMITING AS FAR AS POSSIBLE COSTSFOR THE DU.



The DU is not a manufacturer or importer, so DU qualitate qua are excluded from the obligation to register. However, the general duty of care still applies tohim and requires the DU to assess and document that the risks arising from the substances they use are adequately controlled during their use and thatother users further down the supply chain can adequately assess control the risks. In respect of his duty of care, the DU should prepare a chemical safetyassessment (CSA), under the form of a chemical safety report (CSR; as prescribed by annexe 1.7 of the draft regulation).

According to annexe 11 of the draft regulation, the DU should follow a three-step process to assess the quantity of work his CSR will involve. Under theintroduction of annexe 11, we learn that the DU should not only make a comparison of the exposure scenarios communicated to him by the supplier and thescenarios he is going to implement, but also between the exposure scenarios of the supplier and the ¿exposure scenarios communicated by the DU inrelation to the intended uses further down the supply chain¿.

THE DRAFT REGULATION IS NOT CLEAR ON HOW FAR DOWN THE SUPPLY CHAIN THE INTENDED USES HAVE TO BE TAKEN INTO ACCOUNT.DOES THE SUPPLIER HAVE TO CONSIDER ALL USES OF A SUBSTANCE THROUGHOUT THE WHOLE SUPPLY CHAIN OR ONLY THE USES OF ITSDIRECT CUSTOMER? THE SAME QUESTION GOES FOR THE DU.

For EuPC, it is clear that the CSR should not comprise all the uses till the end consumer of the product. It should contain the uses till the substance istransformed (together with other elements) into an article. If then the article is sold to a maker of a new article (e.g. a plastic roll sold to a handbagmanufacturer), this last use should not be covered by the CSR.EUPC THEREFORE RECOMMENDS THAT THIS PASSAGE BE REFORMULATED SO THAT THIS INTENTION IS MORE APPARENT IN THE LEGALWORDING OF THE REGULATION.

Linked to this remark is the question of what constitutes an article. Although point 2 of the draft gives a definition of ¿article¿, it is not clear to everyone atwhich stage in the production process an object is transformed into an article. This question is of crucial importance since the number of articles and endapplications is huge and it could not possibly be the intention of the Commission to include all these in the REACH system. IT IS THEREFORE ADVISABLETO PROVIDE SOME GUIDELINES (WITH EXAMPLES) OF WHAT CONSTITUTES AN ARTICLE.



Page 28 of 1395


A: General remarkThe draft regulation introduces a very wide-ranging duty upon all actors in the supply chain to ensure that all substances do not adversely affect humanhealth or impact detrimentally on the environment. The draft regulation however does not elaborate on the content of this obligation. Although the principle assuch is known in most member states in one form or another, it is not clear how it should be interpreted in the context of this European regulation.IF THE PRINCIPLE IS UPHOLD IN THE TEXT OF THE REGULATION AS SUCH (SEE UNDER B), FURTHER ELABORATION AND CLARIFICATION ONTHE ROLE THIS PRINCIPLE WILL PLAY HERE IS NEEDED TO GAUGE ITS EXTENT.

B: Duty of care and REACHThe principle is further specified in points 4 and title VI of the draft regulation, requiring from all actors in the supply chain chemical safety assessment (CSA)and chemical safety report (CSR) for all substances manufactured, imported or used, regardless any specific tonnage level or threshold.

This seems to implicate that CSA and CSR will have to be provided irrelevant whether the substance in question is produced in quantities below or above 1ton.

This raises the following concerns:

Firstly, in case of a substance produced in quantities above 1 ton, the draft regulation does not clearly states whether the DU CSA and CSR is sufficient forcompliance with the duty of care. In order to avoid legal uncertainty and to limit the financial and administrative burden on donwstream users (hereafter DU),EUPC RECOMMENDS THAT THE DRAFT REGULATION CLEARLY STATE THAT DU OBLIGATIONS AND THE DUTY OF CARE ARE FULFILLED IFCSA-CSR AND REPORTING OBLIGATIONS ARE DONE ACCORDING TO THE LEGAL PROVISIONS OF THE DRAFT REGULATION.

However, even for substances below 1 ton (and thus normally not falling under the scope of REACH), a CSA and CSR seem to be required. A number of DUuse certain specific chemicals in very limited quantities. The increased financial and administrative burden provoked by the obligation to perform a CSA inaccordance with annexe 11 of the draft regulation will lead to the suppression of a significant number of articles produced in their firms, hamper innovationand result in job losses and even in the closure of a number of these companies. Moreover, since each actor in the supply chain should perform anassessment in regard of each different substance, there will be millions of DU assessments.

IT WOULD THEREFORE BE BETTER IF THE DUTY OF CARE BE EXPRESSED SOLELY AS AN OVERALL PRINCIPLE IN THE PREAMBLE OF THEREGULATION (AS A GENERAL APPEAL TO ALL THOSE HANDLING SUBSTANCES) AND THAT THE CSR BE DEFERRED UNTIL REGISTRATION ISREQUIRED.



1. The list of information to be communicated by all actors in the supply chain is very extensive and even redundant (the safety data sheet alreadycomprising the information). Together with other organisations, we agree that such redundancies can only add to the bureaucracy and may be a source ofinconsistencies between different documents containing similar information. This would result in an overflow of information and possible misunderstanding bythe receiver.

2. Moreover, there is the question how all this needed communication between the different supply levels will function in practice?

Concern is also raised about the need to stipulate uses on registration. This depends upon the correct information being fed back up the supply chain fromwhat can sometimes be an attenuated chain of downstream users. Whilst the onus is on the DU to report unregistered uses, it may not be clear that thesupplier has not registered his particular application, and in some cases the uses may well dictate changes to the safety assessment.



Although the DU is qualitate qua excluded from the obligation to register, the way his supplier registers substances is of crucial importance to him.

A: Intended ¿unintended usesThe text requires DU to carry out additional tests or to provide all the necessary new data in case a substance is used for purposes different from thoseoriginally foreseen in the CSR of the supplier. In case of an unintended use, the DU will have to bear on its own the financial and administrative onus ofgathering the additional information about chemical substances and to find the appropriate structures/institutions to carry out these tests. These costs willoften be too high for SME `s. Obviously, whether a use is intended or not is of crucial importance to the DU.

According to the definition of ¿intended use¿ in point 2 of the draft, one could fear that the registrant (supplier) decides unilaterally which uses are intended.This could lead to situations in which a number of uses will be banned (for business reasons), leaving all the financial onus on the DU. A number of existinguses will be de-selected this way.

EuPC acknowledges that a sentence is specifically inserted in the draft regulation aimed at protecting DU against this danger. Point 11, 1, (a), (iii) of the textstates that at least 90% of the manufactured or imported volume of the registrant should be represented by registrant¿s own use and the intended uses.

HOWEVER, THIS 90% IS CLEARLY NOT ENOUGH. As already mentioned, many SME¿s consume certain specific chemicals in limited quantities(compared to other giant industrial sectors). The feared de-selection will still lead to the suppression of a number of articles and the consequent financialdifficulties for DU, job losses and breaks on innovation.

EUPC THEREFORE STRONGLY URGES THE COMMISSION TO PROVIDE DU WITH THE ASSURANCES THAT ALL THEIR EXISTING USES AREINCLUDED IN THE SUPPLIER¿S REGISTRATION. IT IS EQUALLY IMPORTANT THAT WHERE NEW CHEMICALS ARE CONCERNED, ALL POTENTIALUSES ARE INCLUDED.

The Agency - OtherTopic:

The Agency - Other: Please enter your general comments

EuPC is anxious that the interests of small and medium size enterprises are maintained through the administration of a new system.

WE THEREFORE WOULD LIKE TO INQUIRE WHETHER THERE IS SUFFICIENT SME/DOWNSTREAM USERS REPRESENTATION ON THEDIFFERENT COMMITTEES THAT WILL BE SET UP TO ADVICE THE EUROPEAN CHEMICALS AGENCY, AND REQUEST MORE PARTICIPATIONTHAN ONLY VIA THE SYSTEM OF CONTACTS WITH STAKEHOLDERS ORGANISATIONS.

Page 29 of 1395


121704FEBELTEXOrganisation Industry BE - BelgiumType: Category: Country:



-In the textile production, mostly preparations are used, and not individual chemical substances. A preparation may contain up to 10 substances. A CSR willbe produced for each substance. This means that for an average preparation containing 10 substances the textile operator will receive 10 CSR. Each CSRmay contain 50 till 100 pages (For each sector the number of pages will vary. The chemical sector estimates that the CSR contains 20 till 200pages).A textile dyerecipe is on average made up of 5 chemical preparations (dyestuff, auxiliaries,...). This means 50 CSR for 50 substances in one dyebath orrecipe. But a textile operator is handling 100¿s of recipes in his mill, which means 1000¿s of CSR with in total 100.000¿s of pages.Yet he is requested to assess all CSR's and apply measures where necessary. This is an impossible task; the textile operator will be spending an endlesstime doing just that. Most of the textilecompagnies are SME's. These small and medium sized companies do not have the possibility to cope thisadministrative workload. Moreover they even do not have the (financial) possibility to hire an extra person for just for following up and/or fulfilling allobligations imposed by this new chemicals legislation!

This new chemicals legislation as it is presented now, will not just increase the administrative burden but will also increase the costs substantially.

There is a clear need to simplify the procedure by introducing a CSR per preparation, provided by the supplier, and not per substance.

-The material safety data sheet (MSDS) will continue to exist. This means that a textile operator will receive from his supplier both a CSR and a MSDS. Adouble paper flow largely containing the same subjects twice. This makes no sense.

An extended version of the MSDS can be made obligatory.Upon request of the downstream user the CSR can be passed on just for information purposes. MSDS in this case will play the role of a simplified CSR withjust the necessary information that will allow the downstream user to perform his task without any difficulties.Using MSDS in this respect will solve several workability issues. Some of the merits of using the MSDS can be described as follow: a large number ofstandard phrases already exists in all EU languages, MSDS allow for non dangerous substances in preparations to remain unmentioned, provides a systemof safety threshold that filters out the need to provide information on non hazardous chemicals, MSDS would simplify the users safety assessment and alsoallow for formulations to remain trade secrets without endangering workers or consumers health. MSDS must be per preparation and not per substance andin the language of the user.

-According to the proposed legislation the CSA should cover the life-cycle of the substance. ¿Disposal¿ is already well covered by other legislations andconsequently must remain outside the scope of ¿REACH¿.



-For substances in products and articles with fast innovation cycles (like textile industries), the REACH-process will take to much time.The REACH-process will hamper that textile companies can respond fast to changing customers' wishes and/or market requirements especially for fornon-registered substances in Europe.We therefor insist that "substances in articles" stay outside the scope of this legislation.



-It would be counter productive to provide downstream users with technical documents i.e. MSDS or CSR in a language they don¿t understand. We ask thatthe regulation provides for all information supplied to users to be in the spoken (official) language of the user.



-It would be counter productive to provide downstream users with technical documents i.e. MSDS or CSR in a language they don¿t understand. We ask thatthe regulation provides for all information supplied to users to be in the spoken (official) language of the user.

OtherTopic:


Page 30 of 1395


Studies indicate that 20% till 40% of chemical substances might disappear from the market. As a downstream user, the textile sector, shall be affected a lot.-The textile industry will be depending on the activities and registration efforts of their suppliers. The textile companies will not know which chemicals will notlonger be available.Moreover it might be impossible to find alternatives, which are economical and technical acceptable, for these ceased chemicals,. The textile companies donot have the financial means nor the know how to pass through the whole reach procedure themselves if they want (need !) to use chemicals that are notlonger registered !

- On the other hand the new chemicals legislation can not guaranty that textiles imported from outside the EC are not produced / treated with non-registeredchemicals. This new chemicals legislation will create unfair competition for the Belgian (and European) textile companies. This unfair competition will evenmore dramatic since from the 1st of January 2005 there will be no import quota's anymore for textile products in the EC. The European market will be floodedby non-EC textiles treated with non registered chemicals.

The objective of the new chemicals policy will surely be subverted by non controlled imports. Mainly non EC-companies will profit from this legislation at theexpense of the European industries and even the European citizens!



- 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 downstream user to assess if his use is covered or not. Moreover, it would also allow the chemical producer/importer to assess whetherhe is covering all the ¿intended uses¿ in accordance with his obligations under ¿REACH¿. This would allow for an early and transparent dialogue betweenthe user and the supplier. It would allow for an organique growth of information concerning ¿use¿ prior to the final registration phase. It would solve severalworkability issues related to misinterpretations and misunderstanding of ¿intended use¿ which can lead to several notifications from users to the agencywhich in turn can create heavy administrative burden for the agency and CA¿s. It would also allow consortia formation and sharing of information.

- The pre-registration phase should also include an indication of the volume produced or to be produced per substance. This would allow for a simplecalculation of the volume in relation to the use. This in turn would provide transparency in compliance with point 11(iii) of the regulation for users,producers/importers, the agency and CA¿s.

-It is imperative that the 90% rule be maintained [point 11 (iii)] if not increased to cover as much as 100%. The question is what if the remaining 10% is themost important ¿use¿ for a textile operator? Introducing the ¿intended use¿ in the pre-registration phase would help reducing the risk.



- The responsibilities for REACH being split between Member States, the Commission and the Chemicals Agency, will result in more complexe proceduresand bureaucratic decision-making.- At the moment we feel that Member States are not quite involved. How will be ensured that they can manage their responsabilities properly?

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121705FedichemOrganisation Industry BE - BelgiumType: Category: Country:



Where can we put our General remarks?Please find here the General REMARKS OF FEDICHEM...

PAGE 1

1. General Remarks1.1. IntroductionFedichem, representing the chemical industry in Belgium, supports the political objectives of the draft regulation but has serious concerns on theimplementation of the regulation. The regulation will not reach it goals if it is adopted as proposed presently. As a consequence it will not increase theprotection of human health and the environment. Fedichem also have serious concerns about the impact on the competitiveness of the industry as a wholeand the employment of its employees in Europe.Fedichem supports the Cefic comments and the political messages of Cefic. The remarks formulated in this document are complementary to the Ceficcomments and give an added value from a point of view of a national federation representing 750 producers, downstream users and a lot of SMEs in theBelgian chemical industry.The remarks given in this document are not complete because of the short time limit to study the draft regulation. The presentation in English and the veryshort time limit to comment on the draft regulation is particularly a problem for the large number of SMEs within our membership. We make reference to theCefic remarks which are much more complete on this respect.The costs, bureaucracy and uncertainty of the draft regulation will have an impact on decisions for new investments, induce a delay for decision on futureinvestments or induce investments outside the EU. This can threaten future developments within the EU. Decisions are indeed made on the basis of maximalcertainty, especially in economic less favourable periods. The only way to avoid this is to develop a workable system using the knowledge and expertise ofindustry.

1.1.1. Structure of the Fedichem commentsFedichem has identified different workability problems in the different `vertical¿ parts of the regulation, e.g. chemical safety assessment, registration,authorisation... The Fedichem comments are in this respect analogous to the structure required by the Commission. These remarks can be found under therespective topics proposed by the Commission.

Fedichem also identified some `horizontal¿ issues, which will have a large impact on the workability of the regulation. The most important `horizontal¿issues, identified by Fedichem are:·Lack of expertise and manpower·Confidentiality·The impact on preparations·Economic and financial issues and the non-availability of substances on the EU marketThese `horizontal¿ issues can be found under the heading ¿General Remarks¿. The comments will also be repeated in the respective `vertical¿ topicsproposed by the Commission.

Fedichem would like to draw the attention to the Commission on the title ¿Others¿ where we introduced some workability comments on:·Classification and Labelling Inventory·Scope & Definitions·Articles

Duty of care - Other: Please enter your proposed change to the legal text starting with reference of article, paragraph orannex (if you have no proposed changes, please leave blank)

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PAGE 2 (GENERAL REMARKS FEDICHEM)2. Horizontal remarks on the draft regulation2.1. Lack of expertise and manpowerFedichem has serious concerns on the workability of the draft regulation for its members, especially SMEs, for the following aspects:·The elaboration of Chemical safety reports.·The individual evaluation of each ingredient in the new policy for the establishment of the CSR.·The way of handling the information flow to the downstream users. A safety data sheet should be enough. Why do companies have to send dossiers onsubstances to downstream users while they are using preparations and when critical information on dangerous components has been given in the Safetydata sheet?·A lot of comp

Documents

Stakeholders Reactions - European Commissionec.europa.eu/environment/chemicals/reach/background/docs/...Stakeholders Reactions 24/07/2003 *****121677 Organisation Industry AT - Austria