Detailed Explanation
accompanying draft COMMISSION REGULATION (EU) No …/.. of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament
and of the Council as regards microplastics
Article 73(1) second subparagraph of the REACH Regulation requires the Commission to
give a detailed explanation of the reasons why the draft amendment to Annex XVII diverges
from the original proposal (‘Annex XV dossier’) of the dossier submitter or does not take the
opinions from the European Chemicals Agency’s (‘the Agency’) scientific committees into
account.
A. Divergences from the original Annex XV dossier proposal
During the opinion-making process on the Annex XV dossier, the Agency’s scientific
Committees – the Committee for Risk Assessment (‘RAC’) and the Committee for Socio-
economic Analysis (‘SEAC’) – and the Forum for the Exchange of Information on
Enforcement (‘the Forum’) recommended several changes to the restriction wording
proposed in the Annex XV dossier. The Commission decided to include the following
recommended changes in the draft amendment to Annex XVII:
Polymers without carbon atoms in their structure are excluded from the scope of the
restriction due to the absence of relevant ecotoxicity data on whether such polymers in
particle form would pose the same risks as particles originating from polymers with
carbon atoms in their structure;
The definition of microplastics is extended to cover all particles below 5 mm and fibres-
like particles below 15 mm, including nanoparticles; the reason is that microplastic
particles below 0,1 µm pose an equivalent or potentially higher risk to the environment
than particles at microscale and should not be intentionally added to products; however,
the identification and quantification of particles below 0,1 µm currently pose objective
analytical constraints; to ensure legal certainty, the lower size limit of microplastics for
the purpose of enforcing the restriction is therefore set at 0,1 µm, when it is not possible
to characterise or identify those microplastics by existing analytical methods or
accompanying documentation;
A provision is added that the biodegradability of a polymer needs to be proven in at least
three different environmental compartments when group 4 or 5 test methods are used to
demonstrate (bio)degradability for the purpose of the restriction; this would minimise the
risk of excluding a persistent material from the scope of the restriction;
A ban of placing on the market after 6 years for granular infill used on synthetic sports
surfaces is added; the option of a derogation in case of risk management measures
ensuring that annual releases of microplastic do not exceed 7g/m2 are installed within 3
years is not retained; it is considered that a ban is more effective and enforceable than risk
management measures in reducing microplastics releases in the long term;
B. Divergences from the ECHA Committees’ opinions
Furthermore, in drafting the proposed amendment to Annex XVII, the Commission adapted,
or deviated from, the opinions of RAC and SEAC in a number of points:
To ensure legal clarity, it is made explicit that the scope of the proposed restriction is
limited to synthetic polymer microparticles on their own or intentionally present in
mixtures to confer a sought-after characteristic.
The derogations for food, feed, sewage sludge and compost are deleted because
unnecessary, given that the synthetic polymer microparticles in these products are not
intentionally present and therefore do not fall within the scope of the proposed restriction.
Specific conditions and pass criteria are set for testing the (bio)degradability of polymers
for agricultural and horticultural applications (other than EU fertilising products1), in
order to facilitate the development of (bio)degradable alternatives and ensure consistency
with the testing conditions laid down in Regulation (EU) 2019/1009 on fertilising
products;
A transitional period of 6 years is set for the ban on the placing on the market of fragrance
encapsulates, as it is considered appropriate to provide industry with sufficient time to
reformulate all products where no alternatives are currently available;
A transitional period of 12 years is set for the ban on the placing on the market of make-
up, lip and nail ‘leave-on’ cosmetic products, in order to ensure sufficient time to develop
suitable alternatives and limit the costs for industry, which are higher than for other
‘leave-on’ cosmetic products; However, in order to encourage the substitution of
synthetic polymer microparticles in these products before the end of the transitional
period, any make-up, lip and nail ‘leave-on’ cosmetic product still containing synthetic
polymer microparticles after 8 years from the entry into force of the restriction will have
to bear a label informing consumers of this fact.
As regards the risk management measure on instructions for use and disposal, the
possibility of digital access to instructions for use and disposal in electronic format is
introduced to take into account the latest technological developments in electronic
labelling (‘e-labelling’) and widespread use of mobile electronic devices;
An obligation to include instructions for use and disposal in medicinal products for
human or veterinary use is deleted, as it would lead to double regulation; Directive
2001/83/EC on medicinal products for human use and Regulation (EU) 2019/6 on
veterinary medicinal products already require that instructions for use and disposal of
medicinal products for human and veterinary use, respectively, are included on the
packaging or in the package leaflet of the medicinal product;
1
« EU fertilising products » are those covered by Regulation (EU) 2019/1009 and derogated from this
restriction.
As the plastic pellet supply chain is already putting in place voluntarily initiatives to
minimise pellet loss, which will include reporting, the transitional period for reporting
requirements for this sector is decreased from 36 to 24 months.
EUROPEAN
COMMISSION
Brussels, XXX
[…](2022) XXX draft
COMMISSION REGULATION (EU) …/…
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament
and of the Council concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) as regards synthetic polymer microparticles
(Text with EEA relevance)
EN EN
COMMISSION REGULATION (EU) …/…
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament
and of the Council concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) as regards synthetic polymer microparticles
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article
68(1) thereof,
Whereas:
(1) The ubiquitous presence of tiny fragments of synthetic or chemically-modified natural
polymers, which are insoluble in water, degrade very slowly and can easily be
ingested by living organisms, raises concerns about their general impact on the
environment and, potentially, on human health. Those polymers are widespread in the
environment and have also been found in drinking water and food. They accumulate in
the environment and contribute to the microplastic pollution.
(2) A big part of the microplastic pollution forms unintentionally, for example as a result
of the breakdown of larger pieces of plastic waste, or the wear and tear of tyres and
road paint, or the washing of synthetic clothes. However, tiny fragments of synthetic
or chemically-modified natural polymers are also manufactured to be used as such or
added to products.
(3) The Council, in the conclusions of 20 June 2016 on the EU action plan for the circular
economy2 and of 24 March 2017 on international ocean governance 3, called upon the
Commission to propose measures to reduce the discharge of macro- and micro-sized
plastic debris in the marine environment, including a proposal for a ban on polymers
in cosmetics, personal care products and detergents.
1
OJ L 396, 30.12.2006, p 1.
2
https://data.consilium.europa.eu/doc/document/ST-10518-2016-INIT/en/pdf /
3
https://www.consilium.europa.eu/media/24073/st_7348_2017_rev_1_en.pdf
EN 1 EN
(4) In a bid to tackle plastic pollution, in January 2018 the Commission adopted a plastics
strategy4 which aimed, among other things, to reduce all sources contributing to the
microplastic pollution. This commitment was renewed with the publication of the
European Green Deal5 in December 2019, the new Circular Economy Action Plan6 in
March 2020 and the Zero Pollution Action Plan7 in May 2021. The latter, in particular,
includes reducing by 30% the amount of microplastics released into the environment
among its 2030 targets.
(5) In September 2018, the European Parliament called8 on the Commission to introduce a
ban on microplastics in cosmetics, personal care products, detergents and cleaning
products by 2020.
(6) The potential impacts of microplastic pollution on the environment and possibly
human health have raised concerns in various parts of the world. Several Member
States have adopted or proposed dedicated measures. However, a patchwork of
national restrictions potentially hampers the functioning of the internal market and
therefore requires harmonisation at Union level.
(7) On 9 November 2017, the Commission asked9 the European Chemicals Agency (‘the
Agency’) pursuant to Article 69(1) of Regulation (EC) No 1907/2006 to prepare a
dossier with a view to a possible restriction of synthetic, water-insoluble polymers of
5 mm or less (‘synthetic polymer microparticles’) that are present in products to confer
a sought-after characteristic (‘intentionally-present’), in order to address the risk that
those microparticles may pose to the aquatic environment (‘the Annex XV dossier’).
(8) On 29 January 2019, the Agency published the Annex XV dossier10 where it
concludes that the intentional use of synthetic polymer microparticles, resulting in
releases to the environment, poses a risk to the environment that is not adequately
controlled and needs to be addressed on a Union-wide basis. The Agency estimated
that, currently, more than 42 000 tonnes of intentionally-present microplastics are
4
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions: A European Strategy for Plastics
in a Circular Economy (COM/2018/028 final).
5
Communication from the Commission to the European Parliament, the European Council, the Council,
the European Economic and Social Committee and the Committee of the Regions: The European Green
Deal (COM/2019/640 final).
6
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions: A new Circular Economy Action
Plan for a cleaner and more competitive Europe (COM/2020/98 final).
7
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions: Pathway to a Healthy Planet for
All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' (COM/2021/400 final).
8
European Parliament resolution of 13 September 2018 on a European strategy for plastics in a circular
economy (P8_TA(2018)0352).
9
Commission request of 9 November 2017 asking the European Chemicals Agency to prepare a
restriction proposal conforming to the requirements of Annex XVII to REACH.
https://echa.europa.eu/documents/10162/5c8be037-3f81-266a-d71b-1a67ec01cbf9
10
Annex XV restriction report. https://echa.europa.eu/documents/10162/05bd96e3-b969-0a7c-c6d0-
441182893720; Annex to the Annex XV restriction report.
https://echa.europa.eu/documents/10162/db081bde-ea3e-ab53-3135-8aaffe66d0cb.
EN 2 EN
eventually released into the environment every year11. The Annex XV dossier
proposed a differentiated risk management approach to address the risk from such
synthetic polymer microparticles that is not adequately controlled. A complete ban on
the placing on the market was proposed for sectors and applications where the releases
were considered unavoidable. Instructions for use and disposal were proposed to
minimise avoidable releases. A reporting requirement to obtain information on
releases from uses excluded from the ban on the placing on the market was also
suggested.
(9) More specifically, the Annex XV dossier proposed a prohibition of the placing on the
market of any solid polymer contained in microparticles or microparticles which have
a solid polymer surface coating, as a substance on their own or in a mixture in a
concentration equal to or greater than 0,01 % by weight. This is estimated to result in a
cumulative emission reduction of approximately 500 000 tonnes of microplastics over
the 20-year period following the introduction of the prohibition. That corresponds to a
reduction of 70 % of the quantified emissions. The concentration limit of 0,01 %
corresponds to the lowest concentration reported where synthetic polymer
microparticles could still have an influence on the function of a product.
(10) Due to large variability in the composition, properties and dimensions of synthetic
polymer microparticles, the Annex XV dossier did not address specific polymers or
any additives or other substances that the polymers may contain, but analysed a group
of polymers sharing the same intrinsic properties with regard to size, dimension ratio,
solid state, synthetic origin and extreme persistence in the environment.
(11) The Annex XV dossier proposed to exclude degradable or water-soluble polymers and
natural polymers that have not been chemically modified, as they do not possess the
same long-term persistence and, therefore, do not contribute to the identified risk.
(12) The Annex XV dossier proposed a framework of standardised test methods and pass
criteria to identify degradability for the purpose of restriction. The test methods were
designed to measure biotic degradation, although it cannot be excluded that some
abiotic degradation takes place during the test and contributes to the test results. The
test methods were grouped according to their test design and rationale. Groups 1 to 3
include relatively rapid but stringent screening tests. Groups 4 and 5 include screening
and simulation studies which are increasingly more sophisticated, technically
demanding and lengthy, but use testing conditions that are more environmentally
relevant. The Annex XV dossier proposed that meeting the pass criteria in any of the
permitted test methods in groups 1 to 5 is sufficient to demonstrate degradability for
the purpose of restriction.
(13) Water-soluble solid polymers lose their solid state after their release to the
environment, and therefore do not contribute to the identified concern. The Annex XV
dossier therefore proposed internationally-accepted methods to test solubility and to
exclude those water-soluble polymers from the scope of the restriction.
11
ECHA (2020). Background Document to the Opinion on the Annex XV report proposing restrictions on
intentionally added microplastics. https://echa.europa.eu/documents/10162/b56c6c7e-02fb-68a4-da69-
0bcbd504212b
EN 3 EN
(14) The Annex XV dossier furthermore proposed a 5 mm diameter in any dimension as an
upper size limit for the synthetic polymer microparticles addressed. This value is
widely used in the scientific community and in legal acts in some Member States.
Such limit is also consistent with the upper limit of micro-litter (including
microplastics) specified in the Annex to Commission Decision (EU) 2017/84812 and
used for the implementation of Directive 2008/56/EC of the European Parliament and
of the Council13. Finally, according to Annex XV dossier, particles below that size are
more likely to be ingested by biota than larger items.
(15) Certain fibre-like synthetic polymer particles have a length exceeding 5 mm but lower
than 15 mm, for example the particles used for the reinforcement of adhesives and
concrete. As those fibre-like particles are very persistent and contribute to the
identified risk, the Annex XV dossier considered that they should be included in the
scope of the restriction.
(16) To avoid regrettable substitution, i.e. the replacement of synthetic polymer
microparticles with even smaller persistent polymer particles that may pose an equal
or even larger risk to the environment, the Annex XV dossier initially included
particles below the microscale in the scope of the restriction. To be consistent with the
lower size limit already recommended by Commission Recommendation
C/2022/368914, a lower size limit of 1 nm for particles and 3 nm for fibre-like particles
was proposed. However, comments received during the consultation on the Annex XV
dossier pointed out significant practical concerns, including regarding enforcement. To
ensure enforceability, the Annex XV dossier was adjusted and the lower size limit for
the synthetic polymer microparticles increased from 1 nm to 0,1 µm for particles and
from 3 nm to 0,3 µm for fibre-like particles.
(17) Particles containing or coated by a synthetic or chemically-modified natural polymer
that is solid and insoluble in water come in a variety of sizes. When added to a
product, only some of those particles meet the size limits laid down in the Annex XV
dossier and contribute to the identified concern. The Annex XV dossier therefore
proposed that a polymer should be considered within the scope of restriction if, among
other things, at least 1 % by weight of the particles containing or coated by that
polymer meet those size limits.
(18) The Annex XV dossier proposed to exclude several uses or sectors from the
prohibition of the placing on the market. It was proposed to exclude synthetic polymer
microparticles for use at industrial sites because it is easier to control emissions from
such uses than, for example, emissions from consumer or professional uses. To avoid
overregulation regarding certain uses and sectors, it was proposed to exclude
12
Commission Decision (EU) 2017/848 of 17 May 2017 laying down criteria and methodological
standards on good environmental status of marine waters and specifications and standardised methods
for monitoring and assessment, and repealing Decision 2010/477/EU (OJ L 125, 18.5.2017, p. 43).
13
Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a
framework for community action in the field of marine environmental policy (Marine Strategy
Framework Directive) (OJ L 164, 25.6.2008, p. 19).
14
Commission Recommendation C/2022/3689 of 10 June 2022 on the definition of nanomaterial (OJ C
229, 14.6.2022, p. 1).
EN 4 EN
medicinal products within the scope of Directive 2001/83/EC of the European
Parliament and of the Council15 and veterinary medicinal products within the scope of
Regulation (EU) 2019/6 of the European Parliament and of the Council16, EU
fertilising products within the scope of Regulation (EU) 2019/1009 of the European
Parliament and of the Council17, and food additives within the scope of Regulation
(EC) No 1333/2008 of the European Parliament and of the Council18. In the view of
the Agency, potential releases from in-vitro diagnostic devices can be minimised by
setting conditions of use and disposal while ensuring continued socio-economic
benefits of use of such devices. Moreover, derogations from the ban on the placing on
the market are proposed where the risk from releases is expected to be minimised
because synthetic polymer microparticles are contained by technical means,
permanently lose their particle form or are permanently enclosed in a solid matrix
during end use.
(19) The Annex XV dossier assessed several restriction options for granular infill for use
on synthetic sports surfaces and suggested either a ban on the placing on the market
with a transitional period of 6 years, without exemptions, or a ban on the placing on
the market with a transitional period of 3 years, with an exemption from that ban in
case of use of specific risk management measures ensuring that annual releases of
synthetic polymer microparticles from a synthetic sports pitch do not exceed 7 g/m2.
(20) Regarding the prohibition of the placing on the market, for sectors or products
identified during the restrictions process, specific transitional periods were proposed to
allow sufficient time for concerned stakeholders to comply with the restriction and
transition to suitable alternatives, for example, degradable polymers. Such transitional
periods are also necessary for the Member States to prepare for the enforcement of the
restriction. Finally, they minimise costs to society, without causing unnecessary delay
in emission reduction. No transitional periods were proposed for other uses and
products not individually identified during the restriction process.
(21) Concerning the ban on the placing on the market of ‘microbeads’, i.e. synthetic
polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean,
mainly used in rinse-off cosmetic products or detergents, no transitional period was
proposed, as industry was expected to have voluntarily phased out their use by 2020.
For ‘rinse-off’ and ‘leave-on’ cosmetic products without microbeads, the Annex XV
dossier proposed a 4-year and a 6-year transitional period.
(22) For synthetic polymer microparticles encapsulating fragrances, the Annex XV dossier
considered that transitional periods of 5 or 8 years may both be appropriate in terms of
15
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
16
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on
veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
17
Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down
rules on the making available on the market of EU fertilising products and amending Regulations (EC)
No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170,
25.6.2019, p. 1).
18
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on
food additives (OJ L 354, 31.12.2008, p. 16).
EN 5 EN
their economic costs and their economic benefits. For detergents, waxes, polishes and
air care products, a transitional period of 5 years was considered appropriate to give
industry sufficient time to reformulate their products and substitute synthetic polymer
microparticles.
(23) For controlled-release fertilisers, a transitional period of 5 years was considered
justified to allow manufacturers to reformulate their products so that they achieve
appropriate degradability in the environment. For capsule suspension of plant
protection products covered by Regulation (EC) No 1107/2009 of the European
Parliament and of the Council19 and biocidal products covered by Regulation (EU)
528/2012 of the European Parliament and of the Council20, a transitional period of 8
years was considered necessary to give industry sufficient time to reformulate their
products, obtain an authorisation and place them on the market, while maintaining the
benefits of the encapsulation technology in the interim period. As regards other
agricultural and horticultural uses a transitional phase of 5 years was considered
appropriate.
(24) For devices covered by Regulation (EU) 2017/745 of the European Parliament and of
the Council21, 6 years were considered necessary for reformulation and transition to
suitable alternatives.
(25) Where pollution in the environment from synthetic polymer microparticles can be
minimised by the requirement to provide instructions for use and disposal, the Annex
XV dossier proposed a derogation from the prohibition of placing on the market.
Those instructions should explain how to properly use and dispose of products in order
to minimise releases to the environment.
(26) Furthermore, the Annex XV dossier proposed annual reporting requirements to
monitor the effectiveness of the requirement to provide instructions for use and
disposal and improve the evidence base available for the risk management of the uses
of synthetic polymer microparticles exempted from the prohibition of placing on the
market.
(27) On 3 June 2020, the Agency’s Committee for Risk Assessment (RAC) adopted an
opinion22 pursuant to Article 70 of Regulation (EC) No 1907/2006 with respect to the
Annex XV dossier. In that opinion, RAC concurred with the Annex XV dossier’s
conclusions about the identified risks and that the proposed restriction is an
appropriate Union-wide measure to reduce those risks.
(28) RAC considered that, from a risk perspective, it is more appropriate to set no lower
size limit for polymer microparticles, i.e. include all fibre-like particles smaller than
19
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
20
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
21
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
22
https://echa.europa.eu/documents/10162/b4d383cd-24fc-82e9-cccf-6d9f66ee9089
EN 6 EN
15 mm (with regard to the longest dimension of the fibres) and all other particles
smaller than 5 mm. RAC considered that the omission of synthetic polymer
microparticles smaller than 0,1 µm from the scope of the restriction could either
provide for the continued use of synthetic polymer microparticles or even promote a
shift to smaller particle sizes to circumvent the restriction. This could compromise the
effectiveness of the proposed restriction, since the toxicity of particles is expected to
increase the smaller their size.
(29) Furthermore, RAC considered that the criteria for excluding degradable polymers from
the restriction should be more stringent than those proposed by the Annex XV dossier.
Specifically, RAC considered that where it is necessary to perform tests from groups 4
and 5 to justify an exclusion, those tests should be performed and passed in three
relevant environmental compartments and not only in the most relevant compartment,
as proposed in the Annex XV dossier.
(30) With regard to the placing on the market of infill material for use on synthetic sports
surfaces, taking into account considerations of emissions reduction, practicality and
enforceability, RAC expressed a clear preference for a ban on the placing on the
market after a transitional period over an exception from the ban conditional on the
implementation of risk management measures. The main reason for RAC’s preference
was that infill material for use on synthetic turf sport surfaces is the largest contributor
in terms of use of microplastics in products as well as the largest source of
environmental emissions of intentionally-present synthetic polymer microparticles at
European level. RAC had also concerns regarding the effectiveness of the proposed
risk management measures, in particular in relation to existing sport surfaces and
smaller size particles. It also stated that it does not endorse the referred limit of 7
g/m2/year as any sort of acceptable threshold, as this on its own still implies
substantial releases to the environment on a continued basis.
(31) On 10 December 2020, the Agency’s Committee for Socio-economic Analysis
(SEAC) adopted an opinion pursuant to Article 71(1) of Regulation (EC) No
1907/2006, concluding that the proposed restriction is an appropriate Union-wide
measure to address the identified risks taking into account its socio-economic benefits
and costs.
(32) Taking into account RAC’s opinion, SEAC proposed modifications to the restrictions
proposed in Annex XV dossier and considered that the definition of synthetic polymer
microparticles should contain a lower size limit of 1 nm. However, in order to ensure
that it is possible to implement, enforce and monitor the proposed restriction, SEAC
acknowledged that it would be at least temporarily necessary to set a lower size limit
at 0,1 μm (100 nm) when analytical methods or accompanying documentation cannot
confirm the concentration of synthetic polymer microparticles below that size and thus
the compliance with the concentration limit of the restriction cannot be verified.
(33) In addition to the exclusion of natural, degradable, and soluble polymers from the
definition of synthetic polymer microparticles, as proposed by the Annex XV dossier,
SEAC suggested to exclude polymers that do not contain carbon in their chemical
structure as, in its view, current tools to prove persistence are not suitable for such
polymers. However SEAC considered that such exclusion would need to be confirmed
by RAC.
(34) For the use in the encapsulation of fragrances SEAC could not conclude whether 5 or
8 years would be the most appropriate transitional period and recommended to review
EN 7 EN
the need for a transitional period longer than 5 years after the introduction of the
restriction and that such review should not lead to open-ended derogations.
(35) For make-up, lip and nail ‘leave-on’ cosmetic products, due to their low contribution
to the overall emissions of microplastics, as well as the potentially large impact on the
cosmetics industry of a ban of synthetic polymer microparticles in those products,
SEAC considered two additional measures as appropriate alternatives to the ban on the
placing on the market of those products after a 6-year transitional period, as proposed
by the Annex XV dossier: either appropriate instructions for use and disposal or a
transitional period longer than 6 years. However, the uncertainties related to the
different impacts on industry and concerning releases did not allow SEAC to conclude
whether any of those options would be more appropriate than a ban and a 6-year
transitional period, as proposed in the Annex XV dossier.
(36) SEAC noted that the implementation of risk management measures to reduce releases
from granular infill for use on synthetic sports surfaces is likely to entail significantly
lower costs than substituting them with alternatives. However, risk management
measures would not completely eliminate such releases, so they would be less
effective than a ban in the long term. Against this background, SEAC concluded that
a choice of one of the options could only be based on policy priorities.
(37) SEAC notes that information received during the consultation on the SEAC draft
opinion indicates that certain actors in the supply chain of plastic pellets, flakes and
powders (‘plastic pellets’) falling within the definition of synthetic polymer
microparticles are likely to be able to start reporting on their use earlier than after 36
months as proposed in Annex XV dossier due to efforts made to implement voluntary
industry initiatives, such as Operation Clean Sweep.
(38) The Forum for Exchange of Information on Enforcement (‘the Forum’) was consulted
during the restrictions process in accordance with Article 77(4), point (h), of
Regulation (EC) No 1907/2006 and its recommendations were taken into account.
(39) The Forum considered that the measurement of synthetic polymer microparticles
smaller than 0,1 µm poses technical difficulties and noted that, currently, the lowest
technically achievable limit is around 0,1 µm. The Forum further noted that
enforcement authorities may rely on documentary evidence to demonstrate that the
substance or the mixture does not contain particles below 5 mm in concentrations
above the limits imposed by the restriction. However, in case of doubt, the
documentary evidence can only be verified by a valid physical or analytical method, or
both. The Forum thus recommended to include a lower size limit in the definition of
synthetic polymer microparticles. In the event that no lower limit is recommended, the
Forum suggested that a temporary solution for the implementation and enforcement of
the restriction based on what is practicable and in line with the currently available
analytical techniques is considered. In addition, the Forum recommended a review of
the definition after the entry into force of the restriction to reflect the latest scientific
and technological developments.
EN 8 EN
(40) On 23 February 2021, the Agency submitted the opinions of RAC and SEAC23 to the
Commission.
(41) On 22 April 2021, the Agency submitted a RAC supplementary opinion24 to the
Commission. In particular, the Commission had asked RAC to consider i) the
restriction options for infill material for artificial sports surfaces, in view of the
recently published European Committee for Standardization (CEN) technical report
TR17519 Surfaces for sports areas - Synthetic turf sports facilities - Guidance on how
to minimise infill dispersion into the environment; and ii) the exclusion of polymers
without carbon atoms that was proposed by SEAC. RAC reiterated a clear preference
for a ban on the placing on the market of infill material for use on synthetic turf sports
surfaces. Concerning the derogation for polymers without carbon atoms in their
structure, RAC stated that, due to the absence of relevant ecotoxicity data, it was not
possible to conclude that such polymers in particle form would not pose the same risks
as particles originating from polymers with carbon atoms in their structure.
(42) Taking into account the Annex XV dossier, the opinions of RAC and SEAC, the
socio-economic impact and the availability of alternatives, the Commission considers
that there is considerable microplastic pollution arising from the use of synthetic
polymer microparticles on their own or intentionally present in products. That
pollution poses an unacceptable risk to the environment, which needs to be addressed
on a Union-wide basis. It has been demonstrated that microplastic pollution is
extremely persistent, practically impossible to remove from the environment once
emitted and that it accumulates progressively in the environment. It is therefore
necessary to introduce a restriction on the placing on the market of synthetic polymer
microparticles on their own, or intentionally present in mixtures, in order to reduce
emissions without undue delay. Depending on the expected socio-economic impacts
and the availability of alternatives, specific transitional periods and exceptions are
proposed for selected product groups.
(43) Evidence of risk exists for many polymers within the scope of the restriction.
Regarding other polymers, for which there are less data, conclusions about the risk
posed by them can nevertheless be drawn based on objective criteria regarding the
microparticles which contain those polymers or are coated by them. The Commission
considers that groups of polymers that share relevant physical and chemical properties,
particle size and persistence in the environment should be covered by this restriction.
This allows for the objective identification of the substances that fall within the scope
of this restriction.
23
Committee for Risk Assessment (RAC), Committee for Socio-economic Analysis (SEAC)
Opinion on an Annex XV dossier proposing restrictions on intentionally-added microplastics of 10
December 2020. https://echa.europa.eu/documents/10162/a513b793-dd84-d83a-9c06-e7a11580f366
24
Committee for Risk Assessment (RAC) Opinion related to the request by the Executive Director of
ECHA under Art. 77(3)(c) of REACH to prepare a supplementary opinion on: CEN technical report
17519 on risk management measures for artificial pitches and the ESTC study on their effectiveness and
the proposed derogation for polymers without carbon atoms in their structure.
https://echa.europa.eu/documents/10162/17229/art77_3c_mpinfillandnewderogationforpolymers_opi_r
ac_en.pdf/b85be7e7-c0a8-649a-a0db-56e89e39b3d5?t=1619618145726
EN 9 EN
(44) The Commission considers it appropriate to exclude natural, degradable and soluble
polymers from the definition of synthetic polymer microparticles, as they do not
contribute to the risk. Furthermore, the Commission considers justified to exclude
from the scope of the restriction polymers without carbon atoms in their structure as
there is no relevant ecotoxicity data on whether such polymers in particle form would
pose the same risks as particles originating from polymers that have carbon atoms in
their structure.
(45) The Commission considers that synthetic polymer microparticles below 0,1 µm pose
an equivalent or potentially higher risk to the environment than particles between 0,1
µm and 5 mm. The definition of synthetic polymer microparticles should therefore
cover polymers in or coating particles below 5 mm and fibre-like particles below 15
mm. However, the Commission agrees with the Forum and SEAC that the
identification and quantification of particles below 0,1 µm currently pose analytical
constraints because the particles are too small. To ensure legal certainty, in those cases
where existing analytical methods or accompanying documentation are not able to
determine the concentration of synthetic polymer microparticles in the product, the
lower size limit of those microparticles for the purpose of enforcing the restriction
should therefore be set at 0,1 µm.
(46) The Commission agrees with RAC that only polymers which degrade in multiple
environmental compartments should be excluded from the scope of the restriction. It is
widely accepted that a positive result in any of the screening test methods in groups 1
to 3 predicts degradability in all environmental compartments. Consequently, the
Commission considers that passing any of those test methods is sufficient to
demonstrate degradability for the purpose of this restriction. On the other hand, it is
uncertain whether a polymer passing a group 4 or 5 test in one environmental
compartment would have a similar degradation behaviour in another compartment.
Consequently, the Commission considers that, where group 4 or 5 test methods are
used, a polymer needs to pass those tests in at least three environmental compartments
to be excluded from the scope of the restriction.
(47) Synthetic polymer microparticles used in agricultural and horticultural products, for
example to control the release of fertilisers or the water flow between such products
and the soil, reduce the amount of active substances applied to soil and plants and limit
the operator’s exposure to such potentially toxic products as well as their
environmental impact. It is necessary to facilitate the development of environmentally
sustainable alternatives that would allow those beneficial applications to become
‘microplastics-free’ and remain on the market. SEAC considered that the measures
proposed for agricultural and horticultural products would be appropriate only if
degradable alternatives with at least similar functionality would become available in
the medium term. Finally, Regulation (EU) 2019/1009 already lays down the general
principles to assess whether polymers in EU fertilising products are degradable.
Against this background, the Commission considers justified to set specific conditions
and pass criteria for testing the degradability of polymers in products for agricultural
and horticultural applications, other than EU fertilising products, in order to ensure
consistency with the testing conditions laid down in Regulation (EU) 2019/1009 and
facilitate the development of alternatives.
(48) The Commission considers that the risk management measures proposed in the Annex
XV dossier, as modified by RAC and SEAC, are relevant for addressing the risk
identified. However, the Commission considers that the decision on which of those
risk management measures is the most appropriate to address the risk identified taking
EN 10 EN
into account their socio-economic impact, including the consideration of specific
derogations or transitional periods, should be taken case-by-case in the various
applications.
(49) It is not necessary to explicitly exclude food, feed, sewage sludge and compost from
the scope as suggested in the Annex XV dossier and the opinions of RAC and SEAC,
given that the synthetic polymer microparticles in these products are not intentionally
present and therefore do not fall within the scope of this Regulation.
(50) For encapsulation of fragrances, the Commission considers that 6 years is the most
appropriate transitional period as it will provide industry with sufficient time to
reformulate all products where no alternatives are currently available.
(51) The reformulation costs expected for make-up, lip and nail ‘leave-on’ cosmetic
products in response to the proposed restriction are higher than for other ‘leave-on’
cosmetic products. Taking also into account the comparatively lower contribution of
make-up, lip and nail ‘leave-on’ cosmetic products to the overall emissions, the
Commission considers that a transitional period of 12 years for the ban on placing on
the market of such products is justified in order to ensure sufficient time to develop
suitable alternatives and limit the costs for industry. However, in order to encourage
the substitution of synthetic polymer microparticles in make-up, lip and nail ‘leave-on’
cosmetic products before the end of the transitional period, any make-up, lip and nail
‘leave-on’ cosmetic product still containing synthetic polymer microparticles after …
[OP: insert the date = 8 years from the entry into force of this Regulation] should have
a label informing consumers of this fact.
(52) As regards the risk management measure requiring to supply instructions for use and
disposal, the Commission considers that the latest technological developments in
electronic labelling and widespread use of mobile electronic devices should be taken
into account. The restriction should therefore allow for digital access to instructions
for use and disposal in electronic format as an additional method of providing
information.
(53) Directive 2001/83/EC and Regulation (EU) 2019/6 require instructions for use and
disposal of medicinal products for human and veterinary use, respectively, to be
included on the packaging or in the package leaflet of the medicinal product. The
Commission therefore does not consider that it is needed to introduce additional
obligations for instructions for use and disposal of medicinal products for human or
veterinary use.
(54) As regards the reporting requirements proposed in the Annex XV dossier, as modified
by RAC and SEAC, the Commission finds that they will contribute to monitoring the
effectiveness of the instructions for use and disposal and will improve the evidence
base for the risk management of the uses exempted from the prohibition of placing on
the market.
(55) The loss of plastic pellets represents an important industrial source of microplastics in
the environment. The plastic pellet supply chain is already putting in place voluntarily
initiatives, which will include reporting, to minimise pellet loss. Against this
background, the Commission considers justified a 24-month transitional period for
reporting requirements for this sector.
(56) To avoid double reporting, when there is more than one actor in the supply chain
placing on the market the same product containing synthetic polymer microparticles,
EN 11 EN
only the first actor within that supply chain should provide the required information to
the Agency.
(57) Regulation (EC) No 1907/2006 should therefore be amended accordingly.
(58) The measures provided for in this Regulation are in accordance with the opinion of the
Committee established by Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to
this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
Ursula von der Leyen
EN 12 EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2022) XXX draft
ANNEX
ANNEXES
to the
COMMISSION REGULATION (EU) …/…
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament
and of the Council concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) as regards synthetic polymer microparticles
EN EN
ANNEX
Annex XVII is amended as follows:
(1) the following entry is added:
‘[OP please insert the 1. Shall not be placed on the market as substances
next consecutive on their own or, where the synthetic polymer
number] Synthetic microparticles are present to confer a sought-after
polymer microparticles: characteristic, in mixtures in a concentration equal
polymers that are solid to or greater than 0,01 % by weight.
and which either are
2. For the purposes of this entry, the following
contained in particles
definitions apply:
and constitute at least 1
% by weight of those (a) ‘particle’ means a minute piece of matter, other
particles, or build a than single molecules, with defined physical
continuous surface boundaries;
coating on particles, (b) ‘solid’ means a substance or a mixture other than
where at least 1 % by liquid or gas;
weight of those particles
fulfil either of the (c) ‘gas’ means a substance or mixture which at
following conditions: 50 °C has a vapour pressure greater than 300 kPa
(absolute), or is completely gaseous at 20 °C at a
(a) all dimensions of standard pressure of 101,3 kPa;
the particles are
equal to or less than (d) ‘liquid’ means a substance or mixture that meets
5 mm; any of the following conditions:
(b) the length of the (i) the substance or mixture at 50 °C has a
particles is equal to vapour pressure of not more than 300 kPa, is not
or less than 15 mm completely gaseous at 20 °C and at a standard
and their length to pressure of 101,3 kPa, and has a melting point or
diameter ratio is initial melting point of 20 °C or less at a standard
greater than 3. pressure of 101,3 kPa;
(ii) the substance or mixture fulfils the criteria in
the American Society for Testing and Materials
The following polymers (ASTM) D 4359-90 Standard Test Method for
are excluded from this Determining Whether a Material Is a Liquid or a
designation: Solid;
(a) polymers that are (iii) the substance or mixture passes the fluidity
the result of a test (penetrometer test) described in chapter 2.3.4
polymerisation of Part 2 of Annex A to the European Agreement
process that has
1
taken place in nature, concerning the International Carriage of
which are not Dangerous Goods by Road (ADR) concluded at
chemically modified Geneva on 30 September 1957.
substances;
3. Where the concentration of synthetic polymer
(b) polymers that are microparticles covered by this entry cannot be
degradable as proved determined by existing analytical methods or
in accordance with accompanying documentation, in order to verify the
Appendix [X]; compliance with the concentration limit referred to
(c) polymers that in paragraph 1, only the particles of at least the
have a solubility following size shall be taken into account:
greater than 2 g/L as (a) 0,1 µm for any dimension, for particles where all
proved in accordance dimensions are equal to or smaller than 5 mm;
with Appendix [Y];
(b) 0,3 µm for any dimension, for particles that have
(d) polymers that do a length that is equal to or smaller than 15 mm and a
not contain carbon length to diameter ratio greater than 3.
atoms in their
chemical structure. 4. Paragraph 1 shall not apply to the placing on the
market of:
(a) synthetic polymer microparticles for use at
industrial sites;
(b) medicinal products within the scope of Directive
2001/83/EC and veterinary medicinal products
within the scope of Regulation (EU) 2019/6 of the
European Parliament and of the Council*;
(c) EU fertilising products within the scope of
Regulation (EU) No 2019/1009 of the European
Parliament and of the Council**;
(d) food additives within the scope of Regulation
(EC) No 1333/2008 of the European Parliament and
of the Council***;
(e) in vitro diagnostic devices, including devices
within the scope of Regulation (EU) 2017/746.
5. Paragraph 1 shall not apply to the placing on the
market of the following synthetic polymer
microparticles:
(a) synthetic polymer microparticles which are
contained by technical means so that releases to the
2
environment are prevented when used in accordance
with the instructions for use during the intended end
use;
(b) synthetic polymer microparticles the physical
properties of which are permanently modified
during intended end use in such a way that the
polymer no longer falls within the scope of this
entry;
(c) synthetic polymer microparticles which are
permanently incorporated into a solid matrix during
intended end use.
6. Paragraph 1 shall apply as follows regarding the
following uses:
(a) from… [OP please insert the date: 6 years after
the entry into force of this amending Regulation] to
synthetic polymer microparticles for use in the
encapsulation of fragrances;
(b) from …[OP please insert the date: 4 years after
the entry into force of this amending Regulation] for
‘rinse-off products’ as defined in point (1)(a) of the
Preamble to Annexes II to VI to Regulation (EC) No
1223/2009 unless such products are covered by
point (a) of this paragraph or contain synthetic
polymer microparticles for use as an abrasive, i.e.
namely to exfoliate, polish or clean (‘microbeads’);
(c) from… [OP please insert the date: 12 years
after the entry into force of this amending
Regulation] for lip products as defined in point
(1)(e) of the Preamble to Annexes II to VI to
Regulation (EC) No 1223/2009, nail products as
defined in point (1)(g) of the Preamble to Annexes
II to VI to that Regulation, and make-up within the
scope of that Regulation, unless such products are
covered by points (a) or (b) of this paragraph or
contain microbeads;
(d) from… [OP please insert the date: 6 years after
the entry into force of this amending Regulation] for
leave-on products, as defined in point (1)(b) of the
Preamble to Annexes II to VI to Regulation (EC) No
3
1223/2009, unless such products are covered by
points (a) or (c) of this paragraph;
(e) from… [OP please insert the date: 5 years after
the date of entry into force of this amending
Regulation] for detergents, as defined in Article 2(1)
of Regulation (EC) No 648/2004, waxes, polishes
and air care products, unless those products are
covered by point (a) of this paragraph or contain
microbeads;
(f) from… [OP please insert the date = 6 years after
the date of entry into force of this amending
Regulation] for ‘devices’, within the scope of
Regulation (EU) 2017/745, unless those devices
contain microbeads;
(g) from… [OP please insert the date = 5 years
after the date of entry into force of this amending
Regulation] for ‘fertilising products’, as defined in
Article 2, point (1), of Regulation (EU) 2019/1009,
which do not fall within the scope of that
Regulation;
(h) from… [OP please insert the date = 8 years
after the date of entry into force of this amending
Regulation] for plant protection products within the
meaning of Article 2(1) of Regulation (EC) No
1107/2009****, and biocidal products as defined in
Article 3(1), point (a), of Regulation (EU) 528/2012
of the European Parliament and of the Council*****;
(i) from… [OP please insert the date = 5 years after
the date of entry into force of this amending
Regulation] for products for agricultural and
horticultural uses not covered by points (g) or (h);
(j) from… [OP please insert the date = 6 years
after the date of entry into force of this amending
Regulation] for granular infill for use on synthetic
sports surfaces.
7. From… [OP please insert the date = 24 months
after the date of entry into force of this amending
Regulation] suppliers of products containing
synthetic polymer microparticles referred to in
4
paragraph 4, points (d) and (e), and suppliers of
synthetic polymer microparticles referred to in
paragraph 5 shall provide instructions for use and
disposal to avoid releases of synthetic polymer
microparticles to the environment.
From… [OP please insert the date = 24 months
after the date of entry into force of this amending
Regulation] suppliers of synthetic polymer
microparticles referred to in paragraph 4, point (a),
shall provide the following information:
(a) instructions for use and disposal to avoid
releases of synthetic polymer microparticles to
the environment;
(b) the following statement: ‘The synthetic
polymer microparticles supplied is subject to
conditions laid down by entry [OP please insert
the number of the entry in point (1) of the Annex]
of Annex XVII to Regulation (EC) 1907/2006 of
the European Parliament and of the Council’;
(c) the information on quantity or, as applicable,
concentration of synthetic polymer microparticles
in the substance or mixture;
(d) information on the polymers contained in the
substance or mixture that enables downstream
users and other suppliers to comply with their
obligations laid down in paragraph 8.
From… [OP please insert the date = 8 years after
the date of entry into force of this amending
Regulation] until… [OP please insert the date = 12
years – 1 day after the date of entry into force of this
amending Regulation] suppliers of products
containing synthetic polymer microparticles referred
to in paragraph 6, point (c), shall provide the
following statement: ‘This product contains
microplastics.’
The information referred to in the first, second and
third subparagraphs of this paragraph shall be
provided in the form of clearly visible, legible and
indelible text or, where appropriate regarding the
information in the first and second subparagraphs, in
5
the form of pictograms. The text or, where
appropriate, pictograms, shall be placed on the label,
the packaging, the safety data sheet, or the package
leaflet of the products containing synthetic polymer
microparticles. In addition to the text or, where
appropriate, pictograms, suppliers may provide a
digital tool that gives access to an electronic version
of that information.
Where instructions for use and disposal are provided
in accordance with this paragraph in the form of a
text, they shall be in the official languages of the
Member States where the substance or mixture is
placed on the market, unless the Member States
concerned provide otherwise.
8. Starting from… [OP please insert the calendar
year in which the date 24 months after the date of
entry into force of this amending Regulation falls.
However, if this calculated date is later in the year
than 31 May, please insert the following calendar
year.] manufacturers and industrial downstream
users of synthetic polymer microparticles in the
form of pellets, flakes, and powders used as
feedstock in plastic manufacturing at industrial sites,
and, starting from … [OP please insert the calendar
year in which the date 36 months after the date of
entry into force of this amending Regulation falls.
However, if this calculated date is later in the year
than 31 May, please insert the following calendar
year.], other industrial downstream users using
synthetic polymer microparticles at industrial sites
shall submit the following information to the
Agency by 31 May of each year:
(a) a description of the uses of synthetic polymer
microparticles in the previous calendar year;
(b) for each use of synthetic polymer
microparticles, generic information on the
identity of the polymers used;
(c) for each use of synthetic polymer
microparticles, an estimate of the quantity of
synthetic polymer microparticles released to the
6
environment in the previous calendar year.
From … [OP please insert the calendar year in
which the date 36 months after the date of entry into
force of this amending Regulation falls. However, if
this calculated date is later in the year than 31 May,
please insert the following calendar year], suppliers
of products containing synthetic polymer
microparticles referred to in paragraphs 4, points
(b), (d) and (e), placed on the market for the first
time, and suppliers of synthetic polymer
microparticles referred to in paragraph 5 placed on
the market for the first time shall submit the
following information to the Agency by 31 May of
each year:
(a) a description of the end uses for which the
synthetic polymer microparticles were placed on
the market in the previous calendar year;
(b) for each end use for which the synthetic
polymer microparticles were placed on the
market, generic information on the identity of the
polymers placed on the market in the previous
calendar year;
(c) for each end use for which the synthetic
polymer microparticles were placed on the
market, an estimate of the quantity of synthetic
polymer microparticles released to the
environment in the previous calendar year.
*
Regulation (EU) 2019/6 of the European
Parliament and of the Council of 11 December 2018 on
veterinary medicinal products and repealing Directive
2001/82/EC (OJ L 4, 7.1.2019, p. 43).
**
Regulation (EU) 2019/1009 of the European
Parliament and of the Council of 5 June 2019 laying
down rules on the making available on the market of EU
fertilising products and amending Regulations (EC) No
1069/2009 and (EC) No 1107/2009 and repealing
Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p.
1).
7
***
Regulation (EC) No 1333/2008 of the European
Parliament and of the Council of 16 December 2008 on
food additives (OJ L 354, 31.12.2008, p. 16).
****
Regulation (EC) No 1107/2009 of the European
Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on
the market and repealing Council Directives 79/117/EEC
and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
*****
Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2012
concerning the making available on the market and use
of biocidal products (OJ L 167, 27.6.2012, p. 1).’
(2) the following Appendices … and … [OP: please insert the numbers of the Appendices]
are added:
‘Appendix …
Entry [OP please insert the number of the entry in point (1) of the Annex] – Rules on
proving degradability
This appendix lays down the rules for proving degradability of polymers for the purposes of
entry [OP, please insert the number of the entry in point (1) of the Annex], namely the
permitted test methods and the pass criteria for those methods. The test methods were
designed to measure biotic degradation, although it cannot be excluded that some abiotic
degradation takes place during the test and contributes to the test results.
The tests shall be conducted by laboratories complying with the principles of good laboratory
practice provided for in Directive 2004/10/EC or other international standards recognised as
being equivalent by the Commission or the Agency or accredited to ISO 17025.
1. Test methods
The permitted test methods are organised into five groups, on the basis of their design and
underlying rationale. Meeting the pass criteria in any of the permitted test methods in groups
1 to 3 is sufficient to demonstrate that the polymer or polymers contained in the tested
material and subject to the test are degradable and are therefore excluded from the scope of
entry [OP, please insert the number of the entry in point (1) of the Annex]. Where group 4 or
group 5 tests are used to demonstrate degradability of polymers for uses other than
8
agricultural and horticultural uses, the pass criteria shall be met in at least three of the
following environmental compartments:
- fresh or estuarine water,
- fresh or estuarine water sediment,
- marine water,
- marine sediment,
- marine water/sediment interface,
- soil.
2. Group 1. Screening test methods and pass criteria to demonstrate ready biodegradation
2.1. Permitted test methods in group 1:
T1. ‘Ready Biodegradability’ (OECD TG 301 B, C, D, F)
T2. ‘Ready Biodegradability – CO2 in sealed vessels (Headspace Test)’ (OECD TG 310).
2.2. Pass criteria: 60% mineralisation measured, over 28 days, as evolved CO2 or
consumed O2. The 10-day window requirement mentioned in the T1 and T2 test guidelines
does not need to be fulfilled.
3. Group 2. Modified and enhanced screening test methods and pass criteria to demonstrate
ready biodegradation
3.1. Permitted test methods in group 2:
T1. ‘Ready Biodegradability’ (OECD TG 301 B, C, D, F);
T2. ‘Ready Biodegradability – CO2 in sealed vessels (Headspace Test)’ (OECD TG 310);
T3. ‘Biodegradability in Seawater’ (OECD TG 306).
3.2. For group 2 test methods, the test duration can be extended to up to 60 days and larger
test vessels used.
3.3. Pass criteria: 60% mineralisation measured, over 60 days, as consumed O2 (allowed
for T1 and T2 tests only) or evolved CO2. The 10-day window requirement mentioned in the
T1 and T2 test guidelines does not need to be fulfilled.
4. Group 3. Screening test method and pass criteria to demonstrate inherent degradation
4.1. Permitted test method in group 3:
T4. ‘Inherent Biodegradability: modified MITI Test (II)’ (OECD 302C).
4.2. The pre-adaptation of the inoculum mentioned in the T4 test guideline shall not be
allowed.
9
4.3. Pass criteria: ≥ 70% mineralisation measured as consumed O2 or evolved CO2 within
14 days.
5. Group 4. Screening test methods and pass criteria to demonstrate degradation relative to a
reference material
5.1. Permitted test methods in group 4:
T5. ‘Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous
medium – Method by analysis of evolved carbon dioxide.’ (EN ISO 14852:2018);
T6. ‘Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous
medium – Method by measuring the oxygen demand in a closed respirometer.’ (EN ISO
14851:2004);
T7. ‘Plastics – Determination of aerobic biodegradation of non-floating plastic materials in
seawater/sediment interface – Method by analysis of evolved carbon dioxide’ (EN ISO
19679:2016);
T8. ‘Plastics – Determination of aerobic biodegradation of non-floating plastic materials in
seawater/sandy sediment interface – Method by measuring the oxygen demand in closed
respirometer’ (EN ISO 18830:2016);
T9. ‘Plastics – Determination of the ultimate aerobic biodegradability of plastic materials in
soil by measuring the oxygen demand in a respirometer or the amount of carbon dioxide
evolved’ (EN ISO 17556:2019);
T10. ‘Plastics - Determination of the aerobic biodegradation of non-floating materials
exposed to marine sediment – Method by analysis of evolved carbon dioxide’ (ISO
22404:2019).
5.2. The specifications laid down in ISO 22403:2020 ‘Plastics – Assessment of the
intrinsic biodegradability of materials exposed to marine inocula under mesophilic aerobic
laboratory conditions – Test methods and requirements’ shall be taken into account when
applying T7 and T8.
5.3. For group 4 test methods, the pre-adaptation of the inoculum shall not be allowed.
The result shall be reported as the maximum level of degradation determined from the plateau
phase of the degradation curve, or as the highest value if the plateau has not been reached.
The form, size and surface area of the reference material shall be comparable to that of the
test material. The following materials may be used as reference materials:
- positive controls: biodegradable materials such as micro-crystalline cellulose powder,
ashless cellulose filters or poly-β-hydroxybutyrate.
- negative controls: non-biodegradable polymers such as polyethylene or polystyrene.
5.4. Pass criteria: ultimate degradation of ≥ 90% relative to the degradation of the
reference material within:
- 6 months in aquatic tests, or,
- 24 months in soil, sediment or water/sediment interface tests.
10
6. Group 5. Simulation test methods and pass criteria to demonstrate degradation under
relevant environmental conditions
6.1. Permitted test methods in group 5:
T11. ‘Aerobic and Anaerobic Transformation in Soil’ (OECD TG 307)
T12. ‘Aerobic and Anaerobic Transformation in Aquatic Sediment Systems’ (OECD TG 308)
T13. ‘Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test’ (OECD
TG 309)
6.2. The required test temperatures shall be 12 °C for fresh/estuarine water, fresh/estuarine
water sediment and soil, and 9 °C for marine water and marine sediment because these are
the average temperatures for that compartment in the Union.
6.3. Pass criteria:
- the degradation half-life in marine, fresh or estuarine water is less than 60 days;
- the degradation half-life in marine, fresh or estuarine sediment is less than 180
days;
- the degradation half-life in soil is less than 180 days.
7. Specific requirements for demonstrating the degradability of polymers in products
for agricultural and horticultural applications
Where group 4 or group 5 test methods are used, the degradability of polymers in products
for agricultural or horticultural applications shall be demonstrated in at least two
environmental compartments chosen as follows:
Compartment 1: fresh, estuarine or marine water;
Compartment 2: soil.
To be considered degradable for the scope of entry [OP please insert the number of the entry
in point (1) of the Annex], a polymer in a product for agricultural or horticultural applications
shall achieve 90 % degradation in:
(a) soil within 48 months after the end of that product functionality period; the
functionality period is the time following the product application during which the
product exerts its function.
(b) water within:
(i) 12 months plus 1/4 of the product functionality period, where group 4 test
methods are used; or
(ii) 16 months plus 1/3 of the product functionality period, where group 5 test
methods are used.
11
To this end, the pass criteria for group 4 and 5 test methods shall be modified to indicate the
percentage of degradation (for group 4) or the half-life (for group 5) that needs to be observed
at the end of the standard test duration in order to achieve the conditions laid down in the
previous paragraph.
The modified pass criteria of group 4 and 5 test methods are set in Tables A and B,
respectively.
Table A: Group 4 pass criteria for polymers in products for agricultural or horticultural
applications, listed by duration of the functionality period (FP) and type of test.
Test method Criterion Pass Pass Pass Pass Pass Pass Pass Pass Pass
assessed criterion criterion criterion criterion criterion criterion criterion criterion criteri
(FP=0) (1 month (2 month (3 month (6 month (9 month (12 (18 on (24
FP) FP) FP) FP) FP) month month month
FP) FP) FP)
T9 (soil) % of ultimate
degradation
relative to the
degradation
of the
reference
material after
24 months
≥ 68% ≥ 67,5% ≥ 67% ≥ 66% ≥ 64% ≥ 62% ≥ 60% ≥ 57% ≥ 54%
T5 and T6 % of ultimate
(water) degradation
relative to the
degradation
of the
reference
material after
6 months
Table B: Group 5 pass criteria for polymers in products for agricultural or horticultural
applications, listed by duration of the functionality period (FP) and type of test.
Test Criterion Pass Pass Pass Pass Pass Pass Pass Pass Pass
method assessed criterion criterion criterion criterion criterion criterion criterion criterion criterion
(FP=0) (1 month (2 month (3 month (6 month (9 month (12 month (18 month (24 month
FP) FP) FP) FP) FP) FP) FP) FP)
T11 Half-life Half-life Half-life Half-life Half-life Half-life Half-life Half-life ≤ Half-life ≤ Half-life ≤
(DT50) ≤ 440 ≤ 449 ≤ 458 ≤ 467 ≤ 495 ≤ 522 550 days 605 days 660 days
observed at days days days days days days
the end of
the
12
standard
test
duration
T13 Half-life Half-life Half-life Half-life Half-life Half-life Half-life Half-life ≤ Half-life ≤ Half-life ≤
(DT50) ≤ 147 ≤ 150 ≤ 153 ≤ 156 ≤ 165 ≤ 174 183 days 202 days 220 days
observed at days days days days days days
the end of
the
standard
test
duration
In case the duration of the functionality period falls in between two values of Tables A or B,
the applicable pass criterion shall be the more stringent of the two.
8. Specific requirements for the test material to be used in degradation tests
The test material shall be comparable in terms of composition, form, size and surface area to
the polymer particles present in the product or, if not technically feasible, to the particles that
are disposed or released to the environment. Comparability is important as the composition,
form, size and surface area of particles affect the degradation behaviour.
Polymers used for encapsulation may be tested:
- in the form placed on the market, or,
- in the form of isolated coating, or,
- in the form placed on the market where the organic core of the material is replaced
by an inert material such as glass.
The test material shall be of comparable thickness to the solid polymer coating of the particle
placed on the market. When the degradation is assessed in relation to a reference material, as
referred to in point 5.3., the form, size and surface area of the reference material shall be
comparable to that of the test material. Where the test material is a blend of more than one
polymer, the degradation of the blend as well as that of each of the polymers in the blend
shall be demonstrated. This shall be done by:
- separately testing the degradation of the blend and of each polymer in the blend
using the permitted test methods and pass criteria set out in this Appendix, or,
- demonstrating, by any appropriate means, that all polymers in the blend contribute
to the degradation observed during testing and that each polymer meets the pass
criteria in the relevant permitted test method.
13
Appendix [OP: please insert the number of the Appendix]]
Entry [OP, please insert the number of the entry in point (1) of the Annex] - Rules on
proving solubility:
This appendix lays down the permitted test methods and the test conditions to prove that a
polymer is soluble for the purposes of entry [OP, please insert the number of the entry in
point (1) of the Annex]. The tests shall be conducted by laboratories complying with the
principles of good laboratory practice provided for in Directive 2004/10/EC or other
international standards recognised as being equivalent by the Commission or the Agency or
accredited to ISO 17025.
Permitted test methods:
1. OECD Guideline 120
2. OECD Guideline 105
The test material shall be comparable in terms of composition, form, size and surface area to
the polymer particles present in the product. For polymeric particles containing inorganic
elements, such as particles encapsulated with inorganic substances or particles where the
polymer is grafted onto an inorganic carrier, it shall be sufficient to demonstrate that the
polymeric part of the particle meets the pass criteria. This may require the testing of the
polymer(s) prior to the formation of the particle.
The conditions for the solubility test shall be the following:
- Temperature 20 ⁰C
- pH 7
- Loading: 10 g/1000 mL
- Test time: 24 h’
14
Microplastics intentionally
added to products
REACH Restriction
REACH Committee
23 September 2022
REACH Restriction of Intentionally-added Microplastics
General logic
Use of product = release of MP?
Yes (always) No or preventable
Instruction for use
Sale ban Derogations BUT and disposal
from sale ban
Reporting MP releases
Transitional from derogated uses
periods
Already regulated Industrial use
• 500 000 t of MP avoided over 20 yrs = 90% IAMP emissions
2
• Costs up to €19 billion for industry and civil society
Definition and Scope (I)
Synthetic solid polymers:
either contained in particles in concentration above 1% w/w
or coating particles
= synthetic polymer microparticles
• 1% of particles = Dimensions below 5 mm (15 mm for fibres)
• No lower size limit – nanoparticles are included in scope; BUT:
100 nm lower size limit for enforcement (300 nm for fibres)
ONLY IF quantification not possible through analytical
methods/documentation
3 Dynamic provision – no need for review
Definition and Scope (II)
Certain polymers are not in scope:
Natural polymers, not chemically modified
Degradable polymers (according to appendix X)
agricultural products ≠ all other products
Soluble polymers (solubility above 2 g /L)
Polymers w/o carbon in their structure
Certain uses are not in scope:
4 Scientific and product-oriented research & development
Definition and Scope (III)
Degradability – Appendix X
Biotic degradation, but some abiotic degradation cannot be excluded.
GLP
To prove degradation and be derogated, pass criteria need to be met:
• for groups 1 to 3: in any of the permitted test methods (all applications)
• for groups 4 and 5 (non-agricultural applications): in any of the permitted test methods,
in at least three environmental compartments
• for groups 4 and 5 (agricultural applications): in any of the permitted test methods, in
soil and a water compartment. Specific pass criteria.
Test material = same composition, form, size and surface area as the
microparticles on the market, or released
5
If blends, individual polymers + blend to be tested
Restriction on placing on the market
Synthetic polymer microparticles:
Shall not be placed on the market as substances on their own or, where
the synthetic polymer microparticles are present to confer a sought-after
characteristic, in mixtures in a concentration equal to or greater than
0,01 % by weight.
IMPORTANT: only microparticles added intentionally to mixtures (and
products) are in scope;
unintentional presence = out of scope
6
e.g.: food, feed, compost
Derogations (I)
Products and uses where emissions are already regulated by EU law:
medicinal products for human and veterinary use;
EU fertilising products within the scope of the FPR;
food additives;
in vitro diagnostic devices, including accessory devices.
Use at industrial sites:
Industrial emissions already regulated in general terms;
7 MP emissions can be prevented/minimised
Derogations (II)
Products for which the release of synthetic polymer microparticles can be
prevented or minimised during use, because:
• The microparticles are contained by technical means;
Eg: chromatography columns, toners.
• The microparticles are permanently modified during end use, losing their
microparticle form;
Eg: swellable polymers in diapers, nail polish, paint.
• The microparticles are permanently incorporated into a solid matrix at
end use.
Eg: concrete fibres, pellets melted into moulded articles.
8
Transitional periods
• To give time to all affected stakeholders to adapt to the sale ban and identify
alternatives
• Sector-specific transitional periods:
‘Rinse-off’ cosmetics = 4 years
‘Leave-on’ cosmetics = 6 years
Make-up, lip and nail cosmetics = 12 years
Encapsulated fragrances = 6 years
Detergents, waxes, polishes and air care products = 5 years
In vivo medical devices and accessory devices = 6 years
Fertilising products not regulated by the FPR = 5 years;
Plant protection products and biocidal products = 8 years
Other products for agricultural and horticultural uses = 5 years
9
Granular infill for use on synthetic sports surfaces = 6 years.
Instructions for use and disposal (I)
Target: Products derogated from the sale ban because their releases of
synthetic polymer microparticle can be prevented or minimised.
• Their manufacturers have to provide instructions on how to use and
dispose of the product to prevent microparticle releases
• Applies to:
Industrial uses
In vitro MD
Feed additives
SPM contained by technical means, permanently modified or incorporated in
a solid matrix at end use
• Does not apply to: medicinal products and EU fertilisers
10
• TP = 24 months
Instructions for use and disposal (II)
• For industrial uses, suppliers of synthetic polymer microparticles need to
provide
The information on use and disposal,
Quantity or concentration of synthetic polymer microparticles in the substance or
mixture;
The information on polymers contained in the substance or mixture that enables
downstream users and other suppliers to comply with their reporting obligations (more on
this on the following slides).
• Text or pictograms
• Optional digital tools (e.g. QR code)
• On the label, the packaging, the safety data sheet, or the package leaflet of
11
the product
Specific labelling requirements
for makeup, lip and nail products
• Make-up, lip and nail ‘leave-on’ cosmetic products = 12 year transitional
period
Needed as the expected reformulation is more complex than for other ‘leave-on’
cosmetics
Low contribution to the risk as their emissions are relatively low.
• However, those companies who can should be encouraged to substitute
synthetic polymer microparticles in their products earlier.
After 8 years (out of 12)
mandatory label indicating the presence of microplastics
12
Reporting requirements
AIM: monitoring the effectiveness of
the instructions for use and disposal
the restriction in general
• Manufacturers and DU of derogated products will have to report the
estimated microplastics emissions from those products to ECHA yearly
• To avoid double reporting, only the first actor supplying the product within a
supply chain should report to ECHA
• TP = 24 months, for pellet manufacturers and industrial downstream users
• TP = 36 months, for other (non-pellet) industrial downstream users and all
suppliers of derogated products containing synthetic polymer microparticles
13
REACH Measures on Intentionally-added Microplastics
Expected timelines
2022 2023
Mar Apr Jun Sept Dec Jan Feb Apr May
ISC REACH Cttee EP + Cil Adoption
scrutiny process
WTO Possible Adoption
REACH Cttee
vote
• ISC: March-July 2022
• WTO notification: Aug – October 2022 (2 mths)
• Discussions with REACH Cttee: Sept-Dec 2022 (3 meetings); possible vote in Dec 2022
• EP and Council scrutiny: Jan-March 2023 (3 mths)
• Adoption: March-April 2023 (procedure = 4-6 weeks)
14
Keskkonnaministeerium
[email protected]
Meie 19.10.2022 nr 1.4-1.2/3419-1
Pöördumine
Lugupeetud koostööpartner
Euroopa Komisjon on esitanud liikmesriikidele aruteluks ning arvamuse avaldamiseks
REACH määruse XVII lisa muutmise eelnõu, millega piiratakse toodetesse ja kemikaalidesse
tahtlikult lisatud sünteetiliste polümeeriosakeste (mikroplast) kasutamist. Kirjale on lisatud
Euroopa Komisjoni poolt liikmesriikidele esitatud piirangueelnõu, selle lisa ja seletuskiri ning
ka selgitav ettekanne.
Ootame teie arvamusi ning seisukohti hiljemalt 2. novembriks e-posti aardessile
[email protected].
Lugupidamisega
(allkirjastatud digitaalselt)
Heidi Alasepp
terviseala asekantsler
Lisad: 1. Explanatory note_MP.docx
2. Microplastics_Act_post ISC.docx
3. Microplastics_Annex_post ISC.docx
4. MP restriction.pptx
Lisaadressaadid:
Kultuuriministeerium
Maaeluministeerium
Majandus- ja Kommunikatsiooniministeerium
Terviseamet
Eesti Keemiatööstuse Liit
Aive Telling 715 3474
[email protected]
Suur-Ameerika 1 / 10122 Tallinn / 626 9301 /
[email protected] / www.sm.ee / registrikood 70001952