EUROPEAN
COMMISSION

Brussels, 25.9.2023
C(2023) 6419 final
ANNEX

ANNEX
to theCOMMISSION REGULATION (EU) …/…
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliamentand of the Council concerning the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH) as regards synthetic polymer microparticles

EN

EN

ANNEX
Annex XVII is amended as follows:(1) the following entry is added:‘[Publications
Office,please insert the next
consecutive
number]Synthetic
polymermicroparticles:

1. Shall not be placed on the market as substanceson 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.

polymers that are solid
and which fulfil both of
the following conditions:

2. For the purposes of this entry, the following
definitions apply:(a) are contained inparticles and constituteat least 1 % by weight of
those particles; or build
a continuous surface
coating on particles;(b) at least 1 % byweight of the particles
referred to in point (a)fulfil either of thefollowing conditions:(i) all dimensions of
the particles areequal to or less than
5 mm;(ii) the length of theparticles is equal toor less than 15 mm
and their length todiameter ratio isgreater than 3.
The following polymers
are excluded from thisdesignation:(a) polymers that are(a) ‘particle’ means a minute piece of matter, otherthan single molecules, with defined physicalboundaries;(b) ‘solid’ means a substance or mixture other than aliquid or gas;(c) ‘gas’ means a substance or mixture which at
50 °C has a vapour pressure greater than 300 kPa(absolute), or is completely gaseous at 20 °C at astandard pressure of 101,3 kPa;(d) ‘liquid’ means a substance or mixture that meets
any of the following conditions:(i) the substance or mixture at 50 °C has avapour pressure of not more than 300 kPa, is notcompletely gaseous at 20 °C and at a standard
pressure of 101,3 kPa, and has a melting point or
initial melting point of 20 °C or less at a standard
pressure of 101,3 kPa;(ii) the substance or mixture fulfils the criteria in
the American Society for Testing and Materials(ASTM) D 4359-90 Standard Test Method for
Determining Whether a Material Is a Liquid or a
Solid;(iii) the substance or mixture passes the fluidity
test (penetrometer test) described in chapter 2.3.4
of Part 2 of Annex A to the European Agreement

1the result of apolymerisation
process that has
taken place in nature,
independently of theprocess
throughwhich they have
been
extracted,
which
are
not
chemically modified
substances;(b) polymers that are
degradable as provedin accordance with
Appendix [X];(c) polymers thathave a solubility
greater than 2 g/L as
proved in accordancewith Appendix [Y];(d) polymers that do
not contain carbon
atoms
in
their
chemical structure.

concerning the International Carriage ofDangerous Goods by Road (ADR) concluded at
Geneva on 30 September 1957;(e) ‘make-up product’ means any substance or
mixture intended to be placed in contact withspecific external parts of the human body, namely
the epidermis, eye brows and eye lashes, with aview to, exclusively or mainly, changing theirappearance;
3. Where the concentration of synthetic polymer
microparticles covered by this entry cannot be
determined by available analytical methods oraccompanying documentation, in order to verify thecompliance with the concentration limit referred toin paragraph 1, only the particles of at least thefollowing size shall be taken into account:(a) 0,1 µm for any dimension, for particles where all
dimensions are equal to or smaller than 5 mm;(b) 0,3 µm in length, for particles that have a lengththat is equal to or smaller than 15 mm and a length
to diameter ratio greater than 3.
4. Paragraph 1 shall not apply to the placing on themarket of:(a) synthetic polymer microparticles, as substanceson their own or in mixtures, for use at industrialsites;(b) medicinal products within the scope of Directive
2001/83/EC and veterinary medicinal products
within the scope of Regulation (EU) 2019/6 of theEuropean Parliament and of the Council*;(c) EU fertilising products within the scope ofRegulation (EU) 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 andof the Council***;(e) in vitro diagnostic devices, including devices

2within the scope of Regulation (EU) 2017/746****;(f) food within the meaning of Article 2 ofRegulation (EC) No 178/2002, not covered by point(d) of this paragraph, and feed as defined in Article
3(4) of that Regulation.
5. Paragraph 1 shall not apply to the placing on themarket of the following synthetic polymer
microparticles, as substances on their own or in
mixtures:(a) synthetic polymer microparticles which arecontained by technical means so that releases to theenvironment are prevented when used in accordancewith the instructions for use during the intended end
use;(b) synthetic polymer microparticles the physicalproperties of which are permanently modified
during intended end use in such a way that thepolymer no longer falls within the scope of thisentry;(c) synthetic polymer microparticles which arepermanently incorporated into a solid matrix during
intended end use.
6. Paragraph 1 shall apply as follows regarding thefollowing uses:(a) from… [Publications Office, please insert thedate = 6 years after the entry into force of thisamending Regulation] to synthetic polymer
microparticles for use in the encapsulation offragrances;(b) from …[Publications Office, please insert thedate = 4 years after the entry into force of thisamending 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 suchproducts are covered by point (a) of this paragraphor contain synthetic polymer microparticles for use
as an abrasive, i.e. namely to exfoliate, polish or
clean (‘microbeads’);

3

(c) from… [Publications Office, please insert thedate = 12 years after the entry into force of thisamending Regulation] for lip products as defined inpoint (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 products
within the scope of that Regulation, unless suchproducts are covered by points (a) or (b) of thisparagraph or contain microbeads;(d) from… [Publications Office, please insert thedate = 6 years after the entry into force of thisamending Regulation] for leave-on products, as
defined in point (1)(b) of the Preamble to Annexes II
to VI to Regulation (EC) No 1223/2009, unless suchproducts are covered by points (a) or (c) of thisparagraph;(e) from… [Publications Office, please insert thedate = 5 years after the date of entry into force of
this amending Regulation] for detergents, as definedin 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 paragraphor contain microbeads;(f) from… [Publications Office, please insert thedate = 6 years after the date of entry into force of
this amending Regulation] for ‘devices’, within thescope of Regulation (EU) 2017/745*****, unless
those devices contain microbeads;(g) from… [Publications Office, please insert thedate = 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 ofthat Regulation;(h) from… [Publications Office, please insert thedate = 8 years after the date of entry into force of
this amending Regulation] for plant protection
products within the meaning of Article 2(1) ofRegulation (EC) No 1107/2009****** and seeds4treated with those products, and biocidal products as
defined in Article 3(1), point (a), of Regulation (EU)No 528/2012 of the European Parliament and of theCouncil*******;(i) from… [Publications Office, please insert thedate = 5 years after the date of entry into force of
this amending Regulation] for products for
agricultural and horticultural uses not covered bypoints (g) or (h);(j) from… [Publications Office, please insert thedate = 8 years after the date of entry into force of
this amending Regulation] for granular infill for use
on synthetic sports surfaces.
7. From… [Publications Office, please insert thedate = 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 explaining toindustrial downstream users how to prevent releasesof synthetic polymer microparticles to theenvironment;(b) the following statement: ‘The synthetic polymer
microparticles supplied is subject to conditions laid
down by entry [Publications Office, please insert
the number of the entry in point (1) of the Annex] ofAnnex XVII to Regulation (EC) No 1907/2006 of
the European Parliament and of the Council’;(c) the information on quantity or, as applicable,
concentration of synthetic polymer microparticles inthe substance or mixture;(d) generic information on the identity of thepolymers contained in the substance or mixture thatenables manufacturers, industrial downstream users
and other suppliers to comply with their obligations
laid down in paragraphs 11 and 12.
8. From… [Publications Office, please insert thedate = 36 months after the date of entry into force of
this amending Regulation] suppliers of products
containing synthetic polymer microparticles referred5

to in paragraph 4, point (e), and from [Publications
Office, please insert the date = 24 months after thedate of entry into force of this amending Regulation]
suppliers of products containing synthetic polymer
microparticles referred to in paragraph 4, point (d),and paragraph 5, shall provide instructions for use
and disposal explaining to professional users and thegeneral public how to prevent releases of synthetic
polymer microparticles to the environment.
9. From … [Publications Office, please insert thedate = 8 years after the date of entry into force of
this amending Regulation] until… [Publications
Office, please insert the date = 12 years – 1 day
after the date of entry into force of this amending
Regulation] suppliers of products referred to inparagraph 6, point (c), containing synthetic polymer
microparticles shall provide the following statement:‘This product contains microplastics.’ However,products placed on the market before [Publications
Office, please insert the date = 8 years after the dateof entry into force of this amending Regulation] are
not required to bear that statement until[Publications Office, please insert the date = 8
years + 2 months after the date of entry into force of
this amending Regulation].
10. The information referred to in paragraphs 7, 8
and 9 shall be provided in the form of clearlyvisible, legible and indelible text or, whereappropriate regarding the information in paragraphs
7 and 8, in the form of pictograms. The text or
pictograms shall be placed on the label, thepackaging, or the package leaflet of the products
containing synthetic polymer microparticles or,regarding the information in paragraph 7, on thesafety data sheet. In addition to the text or
pictograms, suppliers may provide a digital tool thatgives access to an electronic version of that
information.
Where instructions for use and disposal are provided
in accordance with paragraphs 7, 8 and 9 in the form

6

of a text, they shall be in the official languages ofthe Member States where the substance or mixture
is placed on the market, unless the Member Statesconcerned provide otherwise.
11. Starting from… [Publications Office, 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 islater in the year than 31 May, please insert thefollowing calendar year.] manufacturers andindustrial downstream users of synthetic polymer
microparticles in the form of pellets, flakes, andpowders used as feedstock in plastic manufacturing
at industrial sites, and, starting from …
[Publications Office, 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 manufacturers of synthetic polymer
microparticles and other industrial downstream
users using synthetic polymer microparticles atindustrial 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 environment in theprevious calendar year, which shall include also thequantity of synthetic polymer microparticles
released to the environment during transportation.
(d) for each use of synthetic polymer microparticles,
a reference to the derogation laid down in paragraph
4, point (a).
12. From … [Publications Office, please insert the7calendar year in which the date 36 months after thedate of entry into force of this amending Regulation
falls. However, if this calculated date is later in theyear than 31 May, please insert the following
calendar year], suppliers of products containing
synthetic polymer microparticles referred to inparagraphs 4, points (b), (d) and (e), and paragraph
5, placed on the market for the first time toprofessional users and the general public, shallsubmit the following information to the Agency by
31 May of each year:(a) a description of the end uses for which thesynthetic polymer microparticles were placed on themarket in the previous calendar year;(b) for each end use for which the synthetic polymer
microparticles were placed on the market, genericinformation on the identity of the polymers placedon the market in the previous calendar year;(c) for each end use for which the synthetic polymer
microparticles were placed on the market, anestimate of the quantity of synthetic polymer
microparticles released to the environment in theprevious calendar year, which shall include also thequantity of synthetic polymer microparticles
released to the environment during transportation.
(d) for each use of synthetic polymer microparticles,
a reference to the applicable derogation orderogations laid down in paragraph 4, point (b), (d)or (e), or 5 point (a), (b) or (c).
13. The Agency shall make the information
submitted under paragraphs 11 and 12 available to
the Member States.
14. Manufacturers, importers and industrial
downstream users of products containing synthetic
polymer microparticles shall provide specificinformation on the identity of polymers covered bythis entry contained in those products and thefunction of those polymers in the products tocompetent authorities upon their request. The

8

specific information on the polymer identity shall be
sufficient to unequivocally identify polymers andshall at least include the information laid down inpoints 2.1 to 2.2.3 and points 2.3.5, 2.3.6 and 2.3.7
of Annex VI, where applicable.
If the information is not available to industrial
downstream users, they shall request it from their
supplier within 7 days from the receipt of therequest from the competent authorities and shallinform the authorities of the request made without
delay.
Having received the request referred to in thesecond subparagraph, the suppliers shall provide therequested information within 30 days to theindustrial downstream user or directly to thecompetent authority requesting it.
Where the supplier provides the information to theindustrial downstream user, the industrial
downstream user shall forward that information to
the competent authorities without delay.
Where the supplier provides the information directly
to the authority, it shall without delay inform theindustrial downstream user concerned to that effect.
15. Manufacturers, importers and industrial
downstream users of products containing polymers
claimed to be excluded from the designation ofsynthetic polymer microparticles on grounds ofdegradability or solubility shall provide, without
delay, information proving that those polymers aredegradable in accordance with Appendix X or
soluble in accordance with Appendix Y, asapplicable, to competent authorities upon theirrequest.
16. Paragraph 1 shall not apply to placing on themarket of synthetic polymers microparticles, on
their own or in mixtures, placed on the market
before … [Publications Office, please insert thedate of entry into force of this Regulation].
However, the first subparagraph shall not apply to9the placing on the market of synthetic polymers
microparticles for uses listed in paragraph 6.

*

Regulation (EU) 2019/6 of the European
Parliament and of the Council of 11 December 2018 onveterinary 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).
***

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 (EU) 2017/746 of the European
Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive
98/79/EC and Commission Decision 2010/227/EU (OJ L
117, 5.5.2017, p. 176).
*****

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).
******

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 useof biocidal products (OJ L 167, 27.6.2012, p. 1).’10

(2) the following Appendices [X] and [Y] [Publications Office, please insert the numbers of
the Appendices]are added:‘Appendix [X] [Publications Office, please insert the number of the Appendix]
Entry [Publications Office, 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 ofentry [Publications Office, 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 someabiotic 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 andunderlying 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 ofentry [Publications Office, 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 agricultural and horticultural uses, the pass criteria shall be met in threeenvironmental compartments chosen as follows:
Compartment 1: fresh, estuarine or marine water;
Compartment 2:(a) fresh, estuarine or marine sediment; or(b) fresh, estuarine or marine water/sediment interface
Compartment 3: soil.

1.1. Group 1. Screening test methods and pass criteria to demonstrate ready biodegradation
1.1.1. 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).

11

1.1.2. Pass criteria: 60% mineralisation measured, over 28 days, as evolved CO2 orconsumed O2. The 10-day window requirement mentioned in the T1 and T2 test guidelines
does not need to be fulfilled.
1.2. Group 2. Modified and enhanced screening test methods and pass criteria todemonstrate ready biodegradation
1.2.1. 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).
1.2.2. For group 2 test methods, the test duration can be extended to up to 60 days and larger
test vessels used.
1.2.3. 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 theT1 and T2 test guidelines does not need to be fulfilled.
1.3. Group 3. Screening test method and pass criteria to demonstrate inherent degradation
1.3.1. Permitted test method in group 3:
T4. ‘Inherent Biodegradability: modified MITI Test (II)’ (OECD 302C).
1.3.2. The pre-adaptation of the inoculum mentioned in the T4 test guideline shall not beallowed.
1.3.3. Pass criteria: ≥ 70% mineralisation measured as consumed O2 or evolved CO2 within
14 days.
1.4. Group 4. Screening test methods and pass criteria to demonstrate degradation relative toa reference material
1.4.1. 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 14852:2021);
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
14851:2019);
T7. ‘Plastics – Determination of aerobic biodegradation of non-floating plastic materials inseawater/sediment interface – Method by analysis of evolved carbon dioxide’ (EN ISO
19679:2020);

12

T8. ‘Plastics – Determination of aerobic biodegradation of non-floating plastic materials inseawater/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 insoil 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’ (ISO22404:2019).
1.4.2. 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.
1.4.3. 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 thetest 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.
1.4.4. Pass criteria: ultimate degradation of ≥ 90% relative to the degradation of thereference material within:- 6 months in aquatic tests, or,- 24 months in soil, sediment or water/sediment interface tests.
1.5. Group 5. Simulation test methods and pass criteria to demonstrate degradation underrelevant environmental conditions
1.5.1. 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’ (OECDTG 309)1.5.2. 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 those compartments in the Union.
1.5.3. Pass criteria:13-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.

2. Specific requirements for demonstrating the degradability of polymers in products
for agricultural and horticultural applications
2.1 Fertilising products containing polymers which are coating agents or increase the water
retention capacity or the wettability of the productThe degradability of polymers which are coating agents or increase the water retention
capacity or the wettability in fertilising products, as defined in Article 2, point (1), ofRegulation (EU) 2019/1009, which do not fall within the scope of that Regulation shall bedemonstrated in accordance with the delegated acts referred to in Article 42(6) of that
Regulation. In the case of absence of such delegated acts, such polymers shall not be placedon the market in fertilising products which do not fall within the scope of Regulation (EU)2019/1009 after [Publications Office, please insert the date = 5 years after the date of entry
into force of this amending Regulation].
2.2 Agricultural and horticultural products other than fertilising products referred to inparagraph 2.1
Where group 4 or group 5 test methods are used, the degradability of polymers in products
for agricultural or horticultural applications other than fertilising products referred to in point
2.1 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 [Publications Office, please insert the
number of the entry in point (1) of the Annex], a polymer in a product for agricultural or
horticultural applications other than a fertilising product referred to in point 2.1 shall achieve
90 % degradation in:(a) soil within 48 months after the end of that product functionality period; thefunctionality period is the time following the product application during which the
product exerts its function.
(b) water within:(i) 12 months plus the product functionality period, where group 4 test methods areused; or(ii) 16 months plus the product functionality period, where group 5 test methods are
used.

14

To this end, the pass criteria for group 4 and 5 test methods shall be modified to indicate thepercentage of degradation (for group 4) or the half-life (for group 5) that needs to be observedat the end of the standard test duration in order to achieve the conditions laid down in theprevious 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
assessed

T9 (soil)T5 and T6(surfacewater)

Pass
Pass
Pass
Pass
Pass
Pass
criterion criterion criterion criterion criterion criterion(FP=0) (1 month (2 month (3 month (6 month (9 month
FP)
FP)
FP)
FP)
FP)

targetdegradation
after 24months≥ 68,4% ≥ 67,6% ≥ 66,9% ≥ 66,2% ≥ 64,1% ≥ 62,1%

targetdegradation
after 6months≥ 68,4% ≥ 65,4% ≥ 62.7% ≥ 60,2% ≥ 53,6% ≥ 48,2%

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
methodCriterion
assessed

Pass
Pass
Pass
Pass
Pass
Pass
criterion criterion criterion criterion criterion criterion(FP=0) (1 month (2 month (3 month (6 month (9 month
FP)
FP)
FP)
FP)
FP)

T11 (soil,
48 months+ FP)

Degradation
half-life(DegT50)

DegT50≤ 440
days

DegT50 DegT50 DegT50 DegT50 DegT50
≤ 449
≤ 458
≤ 467
≤ 495
≤ 522
days
days
days
days
days

T13
(surfacewater, 16

Degradation
half-life

DegT50≤ 147
days

DegT50 DegT50 DegT50 DegT50 DegT50
≤ 156
≤ 165
≤ 174
≤ 202
≤ 229
days
days
days
days
days

15

months +FP)(DegT50)

For functionality periods not covered in Tables A or B, the pass criteria shall be calculatedusing the exponential decay formulas indicated below.
Group 4, T9 (soil):
The target degradation over 24 months (TD24m) shall be calculated as follows:
TD24m = 1 - exp(-*c*24)
Group 4, T5 and T6 (surface water)
The target degradation over 6 months (TD6m) shall be calculated as follows:
TD6m = 1 - exp(-*c*6)
Group 5, T11 (soil) and T13 (surface water):
The degradation half-life (DegT50) observed at the end of the group 5 test duration
shall be calculated as follows:
DegT50 = ln(2)/
where:
c is the average number of days per month, calculated as:
c = 365.25/12
 is the degradation rate, calculated as:
for T9 and T11:

T9/T11 = ln(0.1)/-t90,T9/T11

for T5 and T6:

T5/T6 = ln(0.1)/-t90,T5/T6

for T13:

T13 = ln(0.1)/-t90,T13

t90 is the time- to- 90%-degradation, calculated as:
for T9 and T11:

t90,T9/T11 = c*(48 + FP)

for T5 and T6:

t90,T5/T6 = c*(12 + FP)

for T13:

t90,T13 = c*(16 + FP)

FP is the functionality period, expressed in months.

16

3. Specific requirements for the test material to be used in degradation tests
The test shall be performed on a test material consisting of a polymer or polymers containedin or building a continuous coating on particles (‘polymer particles’) comparable in terms ofcomposition, form, size and surface area to the polymer particles present in the product or, if
not technically feasible, to the polymer particles that are disposed of or released to theenvironment.
By way of derogation from the first paragraph, polymers used for encapsulation may betested in any of the following forms:- in the form placed on the market;- in the form of isolated coating;- in the form placed on the market where the organic core of the material is replacedby 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 1.4.3., the form, size and surface area of the reference material shall becomparable to that of the test material.
Where the test material contains more than one polymer and test methods from groups 1, 2 or
3 are used to prove degradation, the degradation of each of the polymers shall bedemonstrated in either of the following ways:--

separately testing the degradation of the test material and of each polymer in thetest material using the permitted test methods and pass criteria set out in thisAppendix,
testing the degradation of the test material using the permitted test methods andpass criteria set out in this Appendix and, during testing, demonstrating, by any
appropriate means, that all polymers in the test material contribute to thedegradation observed during testing and that each polymer meets the pass criteria
in the relevant permitted test method set out in this Appendix.

Where the test material is composed of a single polymer but contains other non-polymericorganic substances in concentration higher than 10% by weight of the test material, and test
methods from groups 1, 2 or 3 are used to prove degradation, either of the following
conditions shall apply:--

the degradation of the test material and of the polymer in the test material shall betested separately using the permitted test methods and pass criteria set out in thisAppendix;
the degradation of the test material shall be tested using the permitted test methods
and pass criteria set out in this Appendix and, during testing, it shall be17demonstrated, by any appropriate means, that the polymer contributes to thedegradation of the test material observed during testing and meets the pass criteria
in the relevant permitted test method set out in this Appendix.

Appendix [Y] [Publications Office, please insert the number of the Appendix]
Entry [Publications Office, 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 apolymer is soluble for the purposes of entry [Publications Office, please insert the number ofthe 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 otherinternational 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 shall be performed on a test material consisting of a polymer or polymers containedin or building a continuous coating on particles (‘polymer particles’) comparable in terms ofcomposition, form, size and surface area to the polymer particles present in the product or, if
not technically feasible, to the polymer particles that are disposed of or released to theenvironment.
By way of derogation from the third paragraph, for polymer particles that have all dimensions
greater than 0,25 mm or have a length to diameter ratio greater than 3 and are longer than
0,25 mm, the size of the polymer particles to be tested shall be reduced in accordance with
OECD guideline 120, so that at least one dimension of the polymer particle or, for polymer
particles that have a length to diameter ratio greater than 3 the length of the polymer particle,
is between 0,125 mm and 0,25 mm. For polymer particles containing inorganic substances in
addition to a polymer or polymers, such as polymer particles encapsulated with inorganic
substances or polymer particles where a polymer is grafted onto an inorganic carrier, it shallbe sufficient to demonstrate that the polymer meets the pass criterion. To this end, it isallowed to test the solubility of the polymer or the polymers prior to the formation of thepolymer particles.
The conditions for the solubility test shall be the following:-

Temperature 20 ⁰C
pH 7
Loading: 10 g/1000 mL

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- Test time: 24 h
Pass criterion: solubility >2 g/L.’

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