Submission of Information on ALTERNATIVES (NON-CONFIDENTIAL)
Submission of information on
Template
for third party submission of information on alternatives for
Applications for Authorisation
non-confidential
Legal name of submitter(s):Danish Environmental Protection Agency, Danish Ministry of the Environment
Table of CONTENTS
1.alternative ID and properties
2.Technical feasibility
3.Economic feasibility
4.Hazards and risks of the alternative
5.Availability
6.Conclusion on suitability and availability of the Alternative
7.other comments
References
APPENDIXES
1.alternative ID and properties
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2.Technical feasibility
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3.Economic feasibility
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4.Hazards and risks of the alternative
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5.Availability
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6.Conclusion on suitability and availability of the Alternative
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7.other comments
Danish comments to the 3 applications for authorization for use of DEHP for “Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]”by DEZA, ARKEMA France and Grupa Azoty Zakłady Azotowe Kędzierzyn S.A.
Since the 3 applications are almost identical the comments provided by Denmark are concerning all 3 applications.
It is clear from the application(s) that there are suitable technical alternatives for most if not all uses of DEHP. This is in line with the Danish proposal for restricting the use of four phthalates including DEHP; a fact that was not questioned during public consultation of that proposal. There might not be one perfect general plasticiser which can replace DEHP in all uses, but alternatives for different uses are available.
This can also be seen from the availability of almost all PVC articles without DEHP that can be found on the EU market. Flooring is one of the clear examples of downstream producers using other plasticisers than DEHP. Vinyl floorings are just one example of articles where a substitution of DEHP is possible and it has already happened. There are other examples of articles where substitution of DEHP is possible as shown in the Danish proposal for restricting the use of four phthalates including DEHP which is already known by ECHAs two committees RAC and SEAC and are publically available on ECHA’s homepage: .
This trend is also verified by the fact that there is a declining in the use of DEHP in EU while at the same time there is an increase in the use of alternatives (e.g. DINP).
The application(s) are referring to the lack of suitable alternatives for them due to no availability of the alternatives. This is obviously inherently correct unless the company also produces alternatives. However seen from the downstream user’s point of view this is not true as demonstrated by the applicants themselves as just discussed. If therefore the applications had been made by downstream users the situation would have been very different as is the case from other applications for authorization of this substance.
Since DINP is one of the most important (and used) alternatives we looked closer to this short chapter in the application(s).
It is stated by the applicant(s) in para 4.11.3 that “In terms of the substance’s overall human health and environmental hazard profile, DINP would appear to be a suitable replacement for DEHP. However, available evidence has identified concerns with regard to human health hazards posed by the substance and, given the not dissimilar DNELs suggested for the substance, together with the classification as a Aquatic Acute toxin 1 identified by some notifiers, from a regulatory risk management perspective, it may not be appropriate to consider DINP as a suitable alternative to DEHP”.It is recognized that there is a reference to Annex 4, but there is not any information in this Annex that helps the deeper understanding this concern.
It is however very interesting to note that the applicants are using different and higher (!) DNELs which of course have a significant impact on the risk assessments as shown in Annex 4; the applicants are NOT using the reference DNELs for DEHP that RAC agreed upon and ECHA published in April 2013. Therefore the above mentioned conclusions are based on a wrong basis. This of course not just relevant for the comparison with DINP but for comparisons made with all the alternatives.
The concerns related to environmental effects are particular interesting for us when looking at the Danish proposal for restriction of four phthalates incl. DEHP. We did not have - and could not get any data from industry - data as such on the potential release to the environment and thereby also a potential source for human exposure through e.g. food. It therefore seems that the applicants are having concerns on the exposure route for other phthalates used for exactly the same articles and since there are no data that documents that there are differences this is worthwhile noticing.
The statement used by the applicant(s) “together with the classification as a Aquatic Acute toxin 1 identified by some notifiers” [our underlining] seems rather odd as it is apparently not the registrant(s) of DINP there is a reference to? We can also say in this respect that in the Annex XV dossier for the four phthalates it is stated that “no effects were shown for benthic or aquatic organisms at the level of solubility for DINP but since the applicants are not in line with this they must apparently have other data which we do not know of. This cannot be identified by us since there is a reference to a confidential report that is not available to us as competent authority.
This is highlighting a general problem. The claimed confidentiality by the applicant of information on the alternatives is limiting very much our possibilities for giving detailed information since it is only the information in Annex 4 that can be used by the public to discuss/come with additional information during this public consultation. It is therefore extremely difficult to give further information as it is not clear what the data sources are. We therefore can make a general reference to the Danish proposal for restricting the use of four phthalates including DEHP which is already known by ECHAs two committees RAC and SEAC and are publically available on ECHA’s homepage:
As a matter of principle we do not see the reasons for claiming confidentiality of information that should be taken from already published data in order for the general public to react on this. Of course we recognize that there might be very few cases where data are confidential even though not knowing of such data on alternatives that the applicant might have gained access to.
A very clear example of the limitations to give information directly related to these applications is seen in chapter 4.11.2 about the technical feasibility of DINP. It is very difficult to comment anything except that DINP is a technically feasible alternative to DEHP – but of course this is also very relevant for the discussions and evaluations in RAC/SEAC and for the Commission.
When looking at the individual applications it is not possible to evaluate the combined exposure from DEHP – and thus it is problematic to give any information on the alternatives that is needed.
CONCLUSION
The conclusion is that there are no reasons to grant any authorization for these general uses. The applicants have not demonstrated that there are situations where DEHP are needed and where alternatives do not exist. Alternatives are used throughout all types of articles used by consumers for which these applications are targeted; we recognize the very special uses where separate applications have been submitted, but for the very general applications we have not seen any solid documentation in the application(s) for uses where alternatives do not exist.
The applicants are producers of the substance and are obviously inherently affected by a not granted authorization (if they do not produce alternatives). They should have tried to find other substances like their competitors in EU on the plasticizer market have already done many years ago, and if authorizations are granted then the frontrunners are punished which is definitely not what the authorization process in REACH were meant to do. Downstream users are only affected as so far they have not been following the situation about DEHP and as alternatives exist they have had the time to switch to other plasticizers put on the market by other producers.
References
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APPENDIXES
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[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture or description of the alternative technology] [insert date of submission]
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