EN   EN 
 
 
 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 relevan ce)  EN 1  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 polymer s are widespread in the 
environment and have also been found  in drinking water and food. They accumulate in 
the environment and contribute to the micro plastic pol lution.  
(2) A big part of the microplastic pollution  form s 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  polymer s 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 governance3, called upon the 
Commission to propose measures to reduce the discharge of macro - and micro -sized 
plastic debris in the marine environment, includin g a proposal for a ban on polymer s  
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 redu ce all sources contributing to the 
microplastic pollution . This commitment was renewed with the publication of the 
European Green Deal5 in December 2019, the new Circ ular Economy A ction P lan6 in 
March  2020 and the Zero Pollution Action Plan7 in May 2021. The latter, in particular, 
include s 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, per sonal 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 d edicated 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 polymer s 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 t o 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 
release s to the environment , poses a risk to the environment that is not adequately 
controlled  and need s to be addressed on a Union -wide ba sis. The Agency estimated 
that, currently, m ore 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 Europe an 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 ne w Circular Economy Action 
Plan f or a cleaner and more competitive Europe  (COM/2020/98 final ). 
7  Communication from the Commission to the European Parliament, the Council, the Eur opean 
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)0 352).  
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/doc uments/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 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 propo sed to  
minimise avoidable releases . A reporting requirement t o 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 propos ed a prohibition of  the placing on the 
market of any solid polymer  contained in micro particle s or microparticles which have 
a solid  polymer surface coatin g, 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 conce ntration 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 syntheti c 
polymer micro particles , 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 polymer s 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 
design ed to measure biotic degrada tion, although it cannot be excluded that some 
abiotic degradation takes place during the test and contributes to the test results . The 
test methods we re grouped according to their test design and rationale. Groups 1 to 3 
includ e 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 A nnex 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 restrictio n.  
                                                 
 
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 (14) The Annex XV dossier furthermore propose d a 5 mm diameter  in any dimension as a n 
upper size limit for the synthetic polymer micro particles  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 consider ed that they should be included in the 
scope of the restriction.  
(16) To avoid regrettable substi tution , 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 micro scale  in the scope of the restriction .  To be consistent wi th 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 
produc t, 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 
prohibiti on 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, i t 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 5  EN medicinal product s 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 
fertilisin g 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 , potentia l releases from i n-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, derogation s from the ban on the  placing on 
the market  are prop osed 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 t ransitional period of 3 years , with a n 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 sector s or product s 
identified during the restrictions process, specific transitional period s 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 encapsulat ing fragrances , the Annex XV dossier 
consider ed 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 t o 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  Regulatio n (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 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 t heir 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 necess ary for reformulat ion 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 derogat ion 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 propose d annual reporting requiremen ts 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 o f 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 doss ier’s 
conclusion s about the identified risks and that the proposed restriction is an 
appropriate Union -wide measure to reduce  those risks. 
(28) RAC consider ed 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 th e 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 15 mm (with re gard to the longest dimension of  the fibres)  and all other particles 
smaller than 5 mm . RAC consider ed that the omission of synthetic polymer 
micro particles smaller than 0,1 µ m from the scope of the restriction could either 
provide for  the continued use of synthetic polymer micro particles 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 excludi ng 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 a n exclusion , those tests should be performed and passed in three 
relevant environmental compartments and not only in the most relevant compart ment, 
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 lar gest 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 ha d also  concern s 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 d oes 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 continu ed 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 restrictio ns 
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 
acknowledge d that it would be at least  temporar ily 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 t hus 
the compliance with the concentration limit of the restriction cannot be verified . 
(33) In addition to the exclu sion 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 persistenc e 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 encapsulat ion of fragrances  SEAC could not conclude whether  5 or 
8 years would be the most appropriate transition al period and recommended to review EN 8  EN the need for a transition al 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 microplastic s, as well as the potentially large impact on the 
cosmetics industry of a ban of synthetic  polymer microp articles  in those products,  
SEAC considered two additional measures as appropriate alternatives to the ban on the 
placing on the market of those products af ter 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 concernin g 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 rele ases 
from granular infill for use on synthetic sports surfaces is likely to entail significantly 
lower costs than substituti ng 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 t hat cer tain 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 propos ed 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  restriction s 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 conside red that the measurement of synthetic  polymer micro particles 
smaller than  0,1 µm  poses technical  difficulties an d noted that , currently , the lowest 
technically achievable limit is around 0,1 µm. The Forum further note d 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 ver ified by a valid physical or analytical method , or 
both. The Forum thus recommend ed to include a lower size limit in the defin ition 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 recommend ed 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 mate rial for artificial sport s 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 minimi se 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 derogat ion 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 poly mers 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 t here 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 accumul ates progressively in the environment . It is therefore 
necessary  to introduce a restriction on the placing on the market o f 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 
micro particles which contain those polymers or are coated by them . The Commission 
considers that group s of polymers  that share  relevant physic al 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 E STC 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 (44) The Commission considers it appropriate to exclude  natural, degradable an d 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 micro particles  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 part icles 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  microp article s for the purpose of enforcing the res triction 
should therefore be set at 0,1 µ m.  
(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 predict s 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 re striction. On the other hand, it is 
uncertain  whether a polymer passing a group 4 or 5 tes t in one environmental 
compartment would have a similar degradation behaviour in another compartment . 
Consequently, t he 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 p olymer microparticles used in  agricultural and horticultural products , for 
example to  contr ol 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 agricultur al and horticultur al products would be appropriate only if 
degradable alternatives with at least  similar functionality would becom e 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 fertilis ing 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 measure s is the most appropriate to address the risk identified  taking  EN 11  EN into account their socio -economic impact , including the consideration of  specific 
derogation s or transitional period s, 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 with in the scope of this Regulation.  
(50) For encapsulat ion of fragrances , the Commission considers that 6 years is the most 
appropriate transitional period  as it will provide industry with sufficient time to 
reformulat e all prod ucts 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 ac count  the comparative ly 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 be fore 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 inform ing 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 int roduce 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 th ey will contribute to monitor ing 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 p lastic pellets  represent s 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 conside rs 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 12  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 wit h 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