EU、マイクロプラスチック添加製品の原則販売禁止を決定

欧州委員会は9月25日、マイクロプラスチックの販売や、マイクロプラスチックが意図的に添加され、使用時にマイクロプラスチックを放出する製品の販売を禁止する規則を採択した（プレスリリース）。同規則は、化学物質の登録、評価、認可、制限（REACH）に関する規則（注）の付属書17を改正するもの。マイクロプラスチックは、環境に一度放出されると、生分解されず、除去もできないことから、生物の体内での蓄積など、生態系への悪影響が指摘されている。同規則は、マイクロプラスチック添加製品を原則販売禁止にすることで、マイクロプラスチックの放出防止を目指す。同規則の施行後は、マイクロプラスチックを添加した対象製品の域内販売が順次禁止される。

同規則は、有機性で不溶性、（生）分解されにくい5ミリメートル以下のすべての合成ポリマー粒子をマイクロプラスチックと定義。マイクロプラスチックを含む製品のうち、マイクロプラスチックを意図的に添加し、かつ使用中にマイクロプラスチックが放出される製品の域内での販売を禁止する。対象品目は、意図的に添加したマイクロプラスチックの最大の放出源となっている、人工芝などスポーツ施設の表面を覆う顆粒（かりゅう）インフィルのほか、角質除去などの目的で添加される化粧品や洗剤、柔軟剤など多岐にわたる。

販売の禁止時期は、対象品目によって大きく異なる。化粧品などで既に使用が廃止されているマイクロプラスチックビーズなどに関しては、同規則の施行から20日後に即時禁止となるが、顆粒インフィルは8年後から、その他のほとんどの対象品目については、4～12年という長期の移行期間を経て販売が禁止される。詳細は、同規則の付属書を参照のこと。

一方で、マイクロプラスチックが添加されているものの、マイクロプラスチックが放出されない、あるいは放出を最低限に抑えることができる製品、産業施設で使用される製品、医療機器や食品などの他のEU法令で規制されている製品は、販売禁止の対象外となる。ただし、こうした製品の製造事業者は、自社製品からのマイクロプラスチックの想定放出量を毎年、欧州化学品庁（EHCA）に報告することや、放出を防止するための使用・廃棄方法に関する説明書を提供することが義務付けられる。なお、意図的に添加されていないが、マイクロプラスチックを含む製品については規制の対象外となる。

（注）REACH規則については、ジェトロの「EU 輸入品目規制　特定危険化学品に関する規制 詳細(393KB)」を参照

（吉沼啓介）

原文のコピーも一応下に付けました

EN ENEUROPEAN
COMMISSION
Brussels, 25.9.2023
C(2023) 6419 final
COMMISSION REGULATION (EU) …/…
of 25.9.2023
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 1 EN
COMMISSION REGULATION (EU) …/…
of 25.9.2023
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 microplastic pollution.
(2) A big part of 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 its conclusions of 20 June 2016 on the EU action plan for the circular
economy2 and of 24 March 2017 on international ocean governance3, 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 2 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
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 3 EN
eventually released into the environment every year11. The Annex XV dossier
proposed a differentiated risk management approach to address the risks from such
synthetic polymer microparticles that are 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 quantified emissions that would otherwise occur. The
concentration limit of 0,01 % corresponds to the lowest concentration level 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 a 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 be sufficient to demonstrate degradability for
the purpose of the restriction.
(13) Water-soluble solid polymers lose their solid state after their release into the
environment, and therefore do not contribute to the identified concern. The Annex XV
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 4 EN
dossier therefore proposed internationally-accepted methods to test solubility and to
exclude those water-soluble polymers from the scope of the restriction.
(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 for 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 on 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
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 5 EN
such uses than, for example, emissions from consumer or professional uses. To avoid
over-regulation regarding certain uses and sectors, it was proposed to exclude
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 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, such as those in
chromatography columns, water filtering cartridges or printer toners, or permanently
lose their particle form because, for example, they swell or form a film, like in diapers,
nail polish or paint, or are permanently enclosed in a solid matrix during end use, such
as fibres added to concrete or pellets used as feedstock for moulded articles.
(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.
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 6 EN
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
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 plant protection products covered by
Regulation (EC) No 1107/2009 of the European Parliament and of the Council19 and
seeds treated with those products, 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, such as seeds coated with colorants or lubricants or
other products which are not or do not contain plant protection products, a transitional
period of 5 years was considered appropriate.
(24) For devices covered by Regulation (EU) 2017/745 of the European Parliament and of
the Council21 which are substances or mixtures, 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
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 7 EN
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-reduction perspective, it is more appropriate to set
no lower size limit for polymer microparticles, i.e. include all fibre-like particles
smaller than 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 the 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 excluding polymers that do not contain carbon in their chemical
EN 8 EN
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 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
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 certain ‘leave-on’ cosmetic products, that is make-up products, lip products and
nail 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 noted 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 9 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. In order to reduce
emissions without undue delay, 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 to confer a sought-after characteristic, for example
colour, texture, bulk, water absorption, fluidity or heat resistance. 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.
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 10 EN
This allows for the objective identification of the substances that fall within the scope
of this restriction.
(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 in all
dimensions pose an equivalent or potentially higher risk to the environment than
particles between 0,1 μm and 5 mm in all dimensions. The definition of synthetic
polymer microparticles should therefore cover polymers in or coating particles below
5 mm in all dimensions and fibre-like particles below 15 mm in length. However, the
Commission agrees with the Forum and SEAC that the identification and
quantification of particles below 0,1 μm in any dimension, or 0.3 μm in length, as the
case may be, currently pose analytical constraints because the particles are too small.
To ensure legal certainty, in those cases where available analytical methods or the
documentation accompanying the product do not permit 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 be set at 0,1
μm in any dimension or 0,3 μm in length, as the case may be. This limit should no
longer apply as soon as new or improved methods become available permitting the
identification and quantification of synthetic polymer microparticles measuring less
than 0,1 μm in any dimension or 0,3 μm in length, as the case may be.
(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 three environmental compartments to be
excluded from the scope of the restriction.
(47) To take into account any scientific developments concerning polymer degradation and
solubility, including new test methods specifically developed to assess the
degradability or solubility of synthetic polymer microparticles, it may be necessary to
review the standardised test methods and pass criteria to demonstrate degradability or
solubility.
(48) Synthetic polymer microparticles used in agricultural and horticultural products, for
example to control the release of fertilisers or plant protection products, or the water
flow between fertilisers 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
EN 11 EN
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, such as fertilising products which are not CE marked when made available
on the market, in order to ensure consistency with the testing conditions laid down in
Regulation (EU) 2019/1009 and facilitate the development of alternatives.
(49) 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
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.
(50) It is not necessary to explicitly exclude 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. On the other hand, food and
feed within the scope of Regulation (EC) No 178/2002 of the European Parliament
and of the Council25 should be excluded from the scope to prevent double-regulation.
(51) 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.
(52) The reformulation costs expected for make-up products, lip products and nail 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
products, lip products and nail 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 products, lip products and
nail products before the end of the transitional period, any make-up product, lip
product and nail product placed on the market still containing synthetic polymer
microparticles should bear a statement informing consumers of this fact starting from
… [Publication Office, please insert the date = 8 years from the entry into force of this
Regulation]. To avoid unnecessary burden for suppliers and product recalls, suppliers
should not be required to provide the above-mentioned statement on the products
which have already been placed on the market before [Publication Office, please insert
25 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying
down the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
EN 12 EN
the date = 8 years after the date of entry into force of this amending Regulation] for a
certain additional period.
(53) For granular infill for use on synthetic sports surfaces, the Commission considers that
increasing the transitional period for the ban on placing on the market to 8 years is
justified in order to ensure that a larger number of existing synthetic sport surfaces
using this product can reach their natural end-of-life before they need to be replaced.
(54) As regards the risk management measure requiring the supplying of instructions for
use and disposal, it is justified to set a transitional period longer than 24 months for
suppliers of in vitro diagnostic devices containing synthetic polymer microparticles to
allow for the information on the appropriate disposal of such microparticles to be
passed down the supply chain and, in case of change to the product leaflet or
packaging, for sufficient time to obtain the necessary regulatory approvals, where
needed. Furthermore, 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.
(55) 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.
(56) 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. The Commission further considers that including a reference to the
applicable derogations in the information to be reported to the Agency is needed in
order to facilitate enforcement without imposing additional burden on industry. In
addition, manufacturers and industrial downstream users should be required to
estimate and report their own emissions. Furthermore, in order to ensure that all
emissions along the supply chain are monitored and reported without adding undue
burden on end users, suppliers of products containing synthetic polymer microparticles
that place those products on the market for the first time to professional users and the
general public are to also estimate, in addition to their own emissions, the downstream
emissions from the moment the product is placed on the market to the moment it is
disposed of after end use and report the total emissions to the Agency. To ensure the
optimal use of the reported information and facilitate enforcement, such information
should be made available to the Member States.
(57) 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 a 24-month transitional period for reporting
requirements for this sector justified.
(58) 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 13 EN
only the first actor within that supply chain should provide the required information to
the Agency.
(59) In order to facilitate the enforcement of this restriction, manufacturers, importers and
industrial downstream users of products containing synthetic polymer microparticles
should provide to competent authorities, upon their request, specific information
enabling the unequivocal identification of the polymers in the scope of this restriction
contained in their products and the function of those polymers in the product.
Furthermore, manufacturers, importers and industrial downstream users claiming that
certain polymers in their products are excluded from the designation of synthetic
polymer microparticles on grounds of degradability or solubility should provide
information proving those properties to competent authorities upon their request.
Industrial downstream users that do not have the required information should request it
from their suppliers first. To protect the confidentiality of commercial information,
suppliers that do not wish to share the requested information with industrial
downstream users should be allowed to provide it directly to the competent authority
requesting it.
(60) To prevent unnecessary product recalls and reduce waste, it is necessary to provide
that synthetic polymers microparticles, on their own or in mixtures, that have been
placed on the market before [Publication Office, please insert the date of entry into
force of this Regulation] may continue to be placed on the market. That rule is not
needed for uses of synthetic polymers microparticles subject to transitional periods.
(61) Regulation (EC) No 1907/2006 should therefore be amended accordingly.
(62) 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, 25.9.2023
For the Commission
The President
Ursula VON DER LEYEN