Date
8 January 2014 / Our reference
Your reference
Consultation number 0004-02
To:
European Chemicals Agency
Comments from the Swedish Chemicals Agency on the Authorization Consultation no 0002-02
Applicants name: ARKEMA FRANCE
Use applied for: DEHP - Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles
Preconditions
The authorisation procedure aims to assure that the risks from SVHCs are properly controlled and that they are progressively replaced by safer alternatives while ensuring the good functioning of the EU internal market.
Authorisations can be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled or that the socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternatives available.
Conclusions
The Swedish Chemicals Agency has undertaken a thorough review of selected items in the application dossier(s). According to our observations the following conclusions were made:
A. The scope of the application(s) is very unclear. The Swedish Chemicals Agency has examined the information about downstream uses given in the different application documents. The description of the scope varies, which makes it impossible to make an opinion about the requested authorization. There is thus reason to refuse this application based on REACH Article 62.4.c.
B. It is not justified that the downstream users can handle the provided raw materials without risks under adequately controlled conditions. This will be further explained below and leads to the conclusion that the SEA route is needed for evaluation of the downstream use.
C. A description and assessment is needed for every area of use included in the application. The applicant(s) describes only the situation for manufacturing, formulation and distribution of DEHP. There is no assessment of the downstream use of the material. As there are different technical solutions for different uses, a general assessment approach is not sufficient. If there is no need and no economic benefit for a downstream use of DEHP in a specified use, there is no reason for an authorization of the use of DEHP in the supply chain for that specific use.
D. A range of technical feasible alternatives are already available for several uses in the application. This is reported by the applicant and thus there is reason to refuse authorization for such uses.
Detailed comments
A: The scope of the application(s) is very unclear
In an application for authorization the end uses, e.g the articles, must be specified. This requirement cannot be less stringent managed than for a restriction proposal under REACH.
In the application itself, there is only a very general description of the uses the requested authorization is intended to cover. The wording is “Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles” …. “So for example, the PVC articles covered by the application include: flooring; roofing; packaging material; tape and self-adhesive foils; luggage bags; rainwear, footwear; curtains and blinds; waterproof clothes (trousers and jacket or overall) and footwear (boots); sandals; balance balls for exercise; bath mats; tarpaulins; tents; garden hoses; inflatable pools and boats; air mattresses; swimming jackets; upholstery; car seats; etc.”. This makes it impossible to make an opinion about the authorization. There is thus reason to refuse this application based on REACH Article 62.4.c.
In addition to this it is possible to try to guess from the information in the documentation provided what the applicant intended to include in “etc”. The Swedish Chemicals Agency has tried to guess by examining the information about downstream uses given in the different application documents. The description of the articles in the application varies depending on where and in which document they are described. It is unclear for some articles if they are expected to be covered by the requested authorization or not.
Some articles are mentioned in the exposure scenarios and thus expected to be intended to be within the scope. The list in the exposure scenario is not identical with the list applied for. Other articles are clearly exempted from the scope. In the grey-zone there are other articles mentioned in the SEA or other documents, while it is never stated anywhere that they are included in the application– only that they can be manufactured from PVC formulations containing DEHP. Which of them are included in “etc” and which are not? There seem not to be any attempt to assess the uses of the grey-zone group of articles anywhere in the documentation. Thus we regard them out of the scope.
With that background, the Swedish Chemicals Agency has compiled a more detailed list of the downstream uses that are mentioned in the exposure scenarios and the example list in the application. With regard to the information in the application(s) the compiled list was evaluated. The evaluation shows that the current information in the application is not sufficient to permit authorization for any of the articles mentioned in the application. Examples from this list of articles are presented in Appendix 1.
B: It is not justified that the downstream users can handle the provided raw materials without risks under adequately controlled conditions.
A full justification is not given by the applicant for the claim that the risk from the downstream use of DEHP is adequately controlled. However, the understanding of the process conditions as well as the communication in the supply chain is referred to in the report about Analysis of alternatives, e.g. page 54. The statements cited are conclusions from the consultation that was carried out with the applicant´s customers/downstream users.
Citations about process understanding: “many of the users towards the end of the supply chain are unlikely to have sufficient understanding of some of the technical properties delivered by the PVC compound supplied by their supplier.” “These users located towards the end of the supply chain may also have a limited understanding of Authorisation requirements”.
Citations about communication in the supply chain: “on a number of occasions, companies that were contacted confirmed that they may not use DEHP themselves but rather sell it downstream (distributors). Others confirmed the manufacture of PVC compounds with DEHP (processors), but were not able to advise on the onward use of the compound.”
The technical properties of a specific article is fundamental for its producer. If the DU don´t understand which technical properties they need for their production, it is even less probable that they understand how to use the material safe at the production site? The material supplier don´t have enough knowledge whether the DU converts the material at appropriate pressures, temperatures, ventilation conditions etc.
If the actors in the supply chain fail to communicate about issues of primary importance like the intended use of the raw material and the most important material properties, it is even less probable that that the information needed for safe use of the material is communicated and understood? The material supplier cannot guarantee that the information about protective recommendations or personal protective equipment has been received or if it is understood by the DU.
It is thus not demonstrated in the application that the risk from the downstream use of the substance is adequately controlled. As the risk is not under control in the downstream use and different technical solutions are needed for different uses, the technical and economic feasibility need to be assessed specifically for each type of article.
C: A description and assessment is needed for every area of use included in the application.
The conclusion from the previous paragraph was the technical and economic feasibility need to be assessed specifically for each type of article. The applicant(s) describes only the situation for manufacturing, formulation and distribution of DEHP. There is no assessment of the downstream use of the material. If there is a need and economic benefit for a downstream use of DEHP, there will also be reasons for an authorization of the use of DEHP in the supply chain, but only for a specific selection of articles where DEHP is needed.
If the best technical solution for the manufacturing of floors is to use other additives than DEHP, there is no reason to grant authorization for such an end use. If the market for DEHP decreases, it is the applicant's responsibility to find new customers, either for DEHP or for any other substances that are available in excess due to the market changes. On the other hand, if DEHP is the best technical and economical choice for a certain type of article, this should be taken into account in an independent assessment within the authorization application process.
In the application for authorization, there is only unstructured information concerning the technical feasibility of some random end uses. Assessment of the economic feasibility of the use of alternatives for specific articles is totally missing.
Since the information for the DU is incomplete or totally missing, it is not possible to give an opinion about authorization for any of the DU articles. There is thus reason to refuse authorization for all DU articles in the application on this basis too.
D: A range of technical feasible alternatives are already available for several uses.
There is information in the report about Analysis of alternatives about alternatives that are both available and technical feasible for use in specified articles covered by the application. For some of the articles there is a whole range of possible alternatives, which already are widely used. For some of the articles only one or two alternatives are reported in this application. For other articles nothing is specified in the application, but by common knowledge we know that alternatives are used.
As the application is incomplete in other respects, no attempts have been made by the Swedish CA to add more information about other alternatives than those already reported by the applicant. However, the availability of the large range of technical feasible alternatives for certain uses in the application is another reason to refuse authorization for such uses.
Appendix 1. List of articles mentioned in the exposure scenarios in the application for authorization
The articles in the lists below are mentioned in the exposure scenarios and thus expected to be intended to be within the scope of the application. The information about alternatives refers to information from the applicant. Other alternative substances may also be available and feasible. Based on the information given in the application there is no ground for authorization for any of the listed articles.
Examples of articles for which feasible alternatives are reported in the application, it is not demonstrated an adequately control of the risk and there is a lack of information.
PVC flooring
Bath mats
Table linen
Bags
PVC rainwear
PVC footwear with direct skin contact / Sandals, clogs, slippers
Garden hoses and tubes
Tarpaulins
Tents
Inflatable pools
Waterbeds
Examples of articles for which it is not demonstrated an adequately control of the risk and where there is a lack of information in the application.
Haberdashery
Tape and self-adhesive foils
Balance balls for exercise
Office supplies files, slip cases and ring binders *)
Wood-PVC composite profiles for fences and patio profiles
Injected seals (It is unclear what kind of article(s) this refer to)
Insulating films (It is unclear what kind of article(s) this refer to)
Mouthpiece of snorkel
Air mattresses
*) Comment from the Swedish CA: Experience from public procurement show that the use of DEHP is negligible in this kind of articles in Sweden.
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