Date
Our reference
8 January 2014
Development of Legislation and Other Instruments
Your reference
Consultation number
0004-02
To:
European Chemicals Agency
Comments from the Swedish Chemicals Agency on the
Authorization Consultation no 0004-02
Applicants name: DEZA a.s.
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
Mall-id: MAG-0001, 12
/14/2012
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.
Swedish Chemicals Agency
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SE202100388001
Swedish Chemicals Agency
Date
8 January 2014
Our reference
Your reference
Consultation number
0004-02
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
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Swedish Chemicals Agency
Date
8 January 2014
Our reference
Your reference
Consultation number
0004-02
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.
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Swedish Chemicals Agency
Date
8 January 2014
Our reference
Your reference
Consultation number
0004-02
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.
4 (5)
Swedish Chemicals Agency
Date
8 January 2014
Our reference
Your reference
Consultation number
0004-02
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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