Comments for Annex XV restriction report

Substance name: microplastics

EC Number: -

CAS Number: -

Scope: Restricting the use of intentionally added microplastic particles to consumer or professional use products of any kind.

Before you fill in the form, read the Public Consultation Guidance and the specific Information Note
as they explain both the process and the proposal itself.

Link to the Public Consultation Guidance
Link to the Information Note

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All non-confidential comments will be made publicly available once a month during the duration of the public consultation.

The Public Consultation is intended to provide ECHA’s Committees with scientific and technical information to assist them in the development of their opinions. Although other information can be submitted, any abusive comments will not published monthly and only published at the end of the process without any response from the Dossier Submitter or the Rapporteurs.

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SECTION III. Non-confidential comments

It is possible to provide both general comments on the Annex XV restriction report subject to this Public Consultation and answers to the specific questions posed. In both cases, it is necessary to provide supporting evidence to allow ECHA’s Committees to take your comments into account. It is important not to leave the submission of any socio-economic information until the public consultation on SEACs opinion but already submit relevant comments at this stage.

  GENERAL COMMENTS
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SPECIFIC INFORMATION REQUESTS
  1:

Paragraph 3(b) of the proposed restriction sets out that ‘polymers that are (bio)degradable’ are not considered to be microplastic for the purposes of the restriction. A tiered approach for establishing if a polymer-containing particle can be considered as (bio)degradable are detailed in Section 2.2.1.6 of the Annex XV report (Table 21 – Appendix X).

Please provide feedback on the approach, test methods and pass/fail criteria that have been proposed, particularly in relation to their clarity, appropriateness, practicality and predictability for assessing the (bio)degradation of microplastics, including any practical experience of applying the proposed criteria to microplastics. Please tell us if further modifications or adaptations, or alternative test methods, pass/fail criteria or guidance should be considered, providing supporting justification.

  * COMPULSORY FIELDS

  2:

The Dossier Submitter has identified that granular infill material used in synthetic turf (i.e. the granules produced from end-of-life tyres or other synthetic elastomeric materials) is consistent with the definition of an intentionally-added microplastic. Further information is needed in order to assess the implications of the restriction on these materials and to assess the possible need for a derogation. The specific information needed is:

  1. The quantity of microplastics used as synthetic turf infill material in individual Member States or the EU/EEA (Tonnes/yr).
  2. The quantity of microplastics released to the environment (Tonnes/yr, all relevant compartments), and an assessment of the different pathways by which microplastics can be released into the environment and an evaluation of their relative importance.
  3. Examples of ‘best practice’ operational conditions (OCs) and risk management measures (RMMs) to prevent or minimise the release of infill material to the environment, including an estimate of their effectiveness.
  4. Information on the costs of implementing ‘best practice’ OCs and RMMs
  5. Information on the impacts to society of restricting the use of microplastics as synthetic turf infill material, i.e. consequences for the availability of sports fields, impacts on producers, installers and users as well as possible broader impacts of emissions associated with the management of rubber granulate waste (e.g. incineration), other externalities such as greenhouse gas emissions, etc.
  * COMPULSORY FIELDS

  3:

The proposed concentration limit of 0.01% weight by weight (w/w) is intended to prevent the intentional use of microplastics and was based on the information available to the Dossier Submitter on the minimum concentration of microplastics added to products to achieve their technical function. For the concentration limit to be considered further, please tell us:

  1. What is the minimum concentration of microplastics (expressed as the w/w concentration of polymer-containing particles) in end products required to fulfil their intended technical function?
  2. In addition, please tell us what proportion of products in each of the categories below contain microplastics to achieve their intended function in concentrations: a) less than 0.001% w/w; b) between 0.001% w/w and 0.01% w/w; c) between 0.01% w/w and 0.1% w/w; d) between 0.1% w/w and 1% w/w; and e) greater than 1.0% w/w. When answering this question, please consider that, as defined in Paragraph 2d of the proposal, a ‘polymer-containing particle’ means either (i) a particle of any composition with a continuous polymer surface coating of any thickness or (ii) a particle of any composition with a polymer content of ≥ 1% w/w. We are interested in information differentiated between the following product categories/functions:
  • Agriculture and horticulture
  • Rinse-off cosmetic products
  • Leave-on cosmetic product
  • Detergents containing fragrance encapsulates
  • Other detergents
  • Waxes and polishes
  • Medical devices, in vitro diagnostic medical devices and medicinal products for human and veterinary use
  • Food supplements and medical food
  • Paints and coatings
  • 3D printing
  • Printing inks
  • Construction products
  • Products used in the oil & gas sector

You may specify additional functions or uses, if necessary

  1. Please tell us about the availability of analytical methods that could be used to detect and quantify microplastics in the products above.
  2. Are you aware of microplastics corresponding to the definition proposed in the restriction being present in a substance or a mixture as an impurity? If so, at what concentrations (% w/w) do these occur?
  * COMPULSORY FIELDS

  4:

According to Paragraph 5b of the proposed restriction (See Table 3, Annex XV report), a derogation is proposed for substances or mixtures containing microplastic where the microplastics is both (i) contained by technical means throughout their whole lifecycle and (ii) any microplastic containing wastes arising are incinerated or disposed of as though they were hazardous waste.

This derogation is primarily intended to be applicable to professional uses of microplastics in medical devices and in vitro diagnostic medical devices (e.g. in hospitals and healthcare facilities), although could also be applicable to other laboratory equipment/consumables. Please provide information on the feasibility and practicalities of implementing the containment of microplastics by technical means and disposal of any microplastic containing wastes by incineration or as though they were hazardous waste for these uses, and any similar uses that would also be permitted on the basis of this proposed derogation.

  * COMPULSORY FIELDS

  5:

The Dossier Submitter has assessed the socio-economic impacts of the proposed restriction based on its understanding of the uses of microplastics. Please provide (i) information on other sectors or uses, beyond those analysed by the Dossier Submitter, that may be affected by the proposed restriction or (ii) additional information to refine the assessment of sectors/uses already presented by the Dossier Submitter. Please bear in mind that the definition of microplastics used in the proposed restriction is substantially broader than the more commonly known “microbeads”. Evidence of these impacts and supporting justifications can be provided on the following topics among others. Where relevant, please distinguish between the impacts of the different elements of the proposed restriction e.g. ban on placing on the market, labelling or instructions for use, reporting.

  1. tonnages of microplastics used, technical function, releases to the environment, including pathways for such releases;
  2. costs and benefits to producers (including of alternatives), professionals, consumers, etc.; Please indicate the actors affected (e.g. producers, formulators, professional users, consumers), including key economic parameters such as profits, number of people employed, etc.
  3. technical and economic feasibility of potential alternatives, including information on product performance, the price differences between microplastics and their alternatives, the number of products that could require reformulation, expected costs and timelines for reformulation and transitioning to a full-scale production using the alternatives, other potential impacts stemming from the transition to alternatives, e.g., discontinuation of certain products, etc; Please indicate critical uses, for which no alternative currently exists and how long it would take to identify such alternatives.
  4. hazard and risk of the alternatives.
  * COMPULSORY FIELDS

  6:

The Dossier Submitter has received information that the 19 polymers in Table 1 below are used in cosmetic products. Table 88 in the annexes to the report includes a non-exhaustive list of further polymers that may or may not be impacted by the proposed restriction. This information was used by the Dossier Submitter to estimate the impacts of the restriction on cosmetic products in ‘low’ and ‘high’ scenarios. These estimates can be refined should additional data be provided in the consultation. If the response to this question is submitted as a confidential attachment, the data will be anonymised and reported in aggregate form only.

  1. Using the template provided (https://echa.europa.eu/documents/10162/0bab188e-cf32-4f21-e13d-689721908c2f), please tell us which polymers (specify the INCI name) used in cosmetic products would be impacted by the proposed restriction (those included below and any other relevant polymers). When answering this question, please consider: i) if the physical form of the polymer is consistent with the proposed definition of a microplastic in the cosmetic mixture at point of release or use by end-users, ii) that (bio)degradable polymers are not considered to be microplastics (see Paragraph 3b of the restriction proposal in Table 3 of the report), iii) that certain uses of microplastics in cosmetic products are proposed to be derogated (e.g., polymer-containing particles that form films are not considered to be microplastics at the point of use, see Paragraph 5b of the restriction proposal in Table 3 of the report).
  2. Please provide information on the formulations containing each INCI that fulfil the microplastic definition or not, i.e., the polymers (specify the INCI name) listed in the table below and any additional polymers identified in a). Please answer in the template provided for each INCI name and differentiate between rinse-off and categories of leave-on cosmetic products. Please provide information on the kilogrammes used in the template.
 

Polymer

(as identified by Industry)

Associated INCI name

Polyethylene

POLYETHYLENE

Polypropylene

POLYPROPYLENE

Polymethylmethacrylate

POLYMETHYL METHACRYLATE

Polytetrafluoroethylene

POLYTETRAFLUOROETHYLENE ACETOXYPROPYL BETAINE

Polyurethane crosspolymer – 1

POLYURETHANE CROSSPOLYMER-1

Polyurethane crosspolymer – 2

POLYURETHANE CROSSPOLYMER-2

Polyamide (nylon) 5

POLYAMIDE-5

Polyamide (nylon) 6

NYLON-6

NYLON 6/12

Polyamide (nylon) 12

NYLON-12

NYLON-12 FLUORESCENT BRIGHTENER 230 SALT

NYLON 12 (not INCI, but encountered on the labels)

NYLON 6/12

Styrene acrylate copolymer

STYRENE/ACRYLATES COPOLYMER

Polyethylene terephthalate

POLYETHYLENE TEREPHTHALATE

Polyethylene isoterephthalate

POLYETHYLENE ISOTEREPHTHALATE

Polybutylene terephthalate

POLYBUTYLENE TEREPHTHALATE

Polyacrylates, acrylates copolymer

ACRYLATES COPOLYMER

ACRYLATES CROSSPOLYMER

Ethylene/Acrylate copolymer

ETHYLENE/ACRYLIC ACID COPOLYMER

Polystyrene

POLYSTYRENE

Methyl methacrylate crosspolymer

METHYL METHACRYLATE CROSSPOLYMER

Polymethylsilsesquioxane

POLYMETHYLSILSESQUIOXANE

Poly lactic acid

POLYLACTIC ACID

  * COMPULSORY FIELDS

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