VCI-Position to ECHA REACH Annex XV Restriction Report

The European Chemicals Agency (ECHA) has, under the REACH Regulation, presented a proposal for limitation under a so-called Annex XV dossier entitled "Proposal for a Restriction - Substances Names: Intentionally added Microplastics". Almost all statements in the dossier suggest that it is a limitation of Microplastics. In fact, however, the proposed restriction addresses all polymers as well as virtually all polymer-containing or polymer-coated materials.

Executive Summary

At the request of the European Commission, the European Chemicals Agency (ECHA) has submitted a proposal to restrict microplastics within the framework of a so-called Annex XV dossier in accordance with the REACH Regulation (title: Proposal for a Restriction: Substance Name(s): intentionally added microplastics). A public consultation on this Annex XV dossier is ongoing until 20 September 2019.

The title of the restriction and also almost all statements in the dossier (e.g. statements on substance identity or risk assessment) suggest that it is a restriction of microplastics. In fact, however, the proposed restriction addresses all polymers and virtually all polymer-containing or polymer-coated materials. The specifications, definitions and scope of the restriction are so complex and so extensive that it is unclear what exactly should be covered.

In the opinion of the VCI, the restriction proposal infringes important provisions of the REACH Regulation and the tenets of the precautionary principle:

1. Insufficient description of substance identity:

The general addressing of all polymers or microplastics does not fulfil the require-ments of the REACH Regulation for a precise identification of the substances to be restricted. Overall, it is unclear in the ECHA Annex XV dossier what exactly should be restricted - polymers or microplastics. The precise identification of the substances to be restricted as required under REACH and a risk assessment and assessment of socio-economic impacts based on this are missing.

2. Lack of identification of hazard and risk

The provisions of Title VIII of REACH are disregarded by proposing a restriction in the absence of the first determining element of the risk - i.e. an identified hazard. Overall, with a simple reference to the "extreme stability" (persistence) of the particles, a fictitious, alleged risk is constructed, without having any evidence of a real risk or - after the scientific risk assessment - having any reasonable cause for concern that can be derived.

3. Lack of detail in the risk assessment

Any risk assessment in accordance with REACH must be substance-related. A grouping of substances may be possible under certain, closely defined conditions. However, the demonstration required under REACH that all polymers or microplastic materials covered by the restriction have the same properties and thus the same risk is not provided.

4. Disregard of the principles and standards for the application of the precautionary principle

The reasoning presented in the Annex XV dossier to justify the proposed restriction does not come up to the standard required in the European Union for the application of the precautionary principle. Overall, the scientific evidence presented in the Annex XV dossier is inadequate, incomplete and inconclusive.

5. Lack of efficacy, effectiveness and proportionality

With the proposed restriction, only a small fraction of the microplastics introduced into the environment will be covered. The REACH requirement that a restriction must be appropriate to reduce risks to an acceptable level within a reasonable time and in a reasonable way is therefore not met.

Moreover, it will be virtually impossible to analytically demonstrate the effectiveness of the restriction by monitoring environmental concentrations resulting from the definition of the materials to be restricted - given the extremely wide particle size range of 1nm to 5mm and the complex structural requirements of e. g. "continuous polymer surface coatings of any thickness".

6. Lack of legal basis for extensive product labelling and for the proposed disproportionate annual reporting requirement

It is not acceptable that a detailed labelling and an extensive annual reporting requirement are to be introduced for almost all polymer-containing products even if they are exempted from the restriction. Such obligations have to be fulfilled by all downstream users. There is no sufficient legal basis for this.

Conclusions / Recommendations

• The VCI does not reject a restriction of certain specified uses of microplastics in principle.
• The VCI prefers that restriction measures be taken within the framework of the REACH regulation.
• However, in order for the restriction now presented to comply with the requirements of the REACH Regulation, extensive adjustments must be made.
• First proposals for such adjustments are contained in the detailed VCI assessment.

Please note:

The full VCI rating is located in the download area at the top of this page.

More information

• Annex XV Restriction Report by ECHA