EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEX  
 
ANNEXES  
 
to the  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards synthetic polymer microparticles  
   
1 
 ANNEX  
Annex XVII is amended as follows :  
(1) the following entry is added:  
 ‘[OP please insert the 
next consecutive 
number ] Synthetic 
polymer microparticles : 
polymer s that are solid 
and which either are 
contained  in particle s 
and constitut e at least 1 
% by weight  of th ose 
particle s, or  build  a 
continuous surface 
coating on particles , 
where at least 1 % by 
weight of th ose particles 
fulfil either of the 
following  conditions : 
(a) all dimensions of 
the particles are 
equal to or less than 
5 mm ; 
(b) the length of the 
particles is equal to 
or less than 15 mm 
and their length to 
diameter ratio is 
greater than 3 .  
 
The following polymer s 
are excluded from  this 
designation : 
(a) polymers that are 
the result of a 
polymerisation 
process that has 1. Shall not be placed on the market a s substance s 
on their own or , where the  synthetic polymer 
microparticles  are present to confer a sought -after 
characteristic , in mixture s in a concentra tion equal 
to or greater than 0, 01 % by weight .  
2. For the purposes of this entry , the following 
definitions apply :  
(a) ‘particle’ mean s a minute piece of matter , other 
than single molecules,  with defined physical 
boundaries ;  
(b) ‘solid’ mean s a substance or a mixture other than  
liquid or gas;   
(c) ‘gas’ mea ns 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 a 
standard pressure of 101, 3 kPa;   
(d) ‘liquid’ mean s a substa nce or mixture that meet s 
any of the following conditions : 
(i)  the substance or mixture at 50  °C has a 
vapou r pressure of not more than 300 kPa, is not 
completely 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  
2 
 taken place in nature , 
which  are not  
chemically modified  
substances ;  
(b) polymers  that are 
degradable  as proved 
in accordance with  
Appendix [X] ; 
(c) polymers that 
have  a solubility 
greater than 2  g/L as 
proved  in accordance 
with  Appendix [Y] ;  
(d) polymers that do 
not contain  carbon 
atom s in their 
chemical structure . 
 
 concerning the International Carriage of 
Dangerous Goods by Road (ADR)  concluded at 
Geneva on 30 September 1957 .  
3. Where the concentration  of synthetic polymer 
micro particles covered by this entry cannot be 
determined by existing analytical methods or 
accompanying documentation,  in order to verify the 
compliance with the concentration limit referred to 
in paragraph 1, only the particles of at least the 
following  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  for any dimension , for particles that have 
a length that 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 the 
market of:  
(a) synthetic polymer microparticles  for use at 
industrial sites;   
(b) medicinal products within the scope  of Directive 
2001/83/EC and veterinary medicinal products 
within the scope of Regulation (EU) 2019/6  of the 
European Parliament and of the Council*;  
(c) EU fertilising products  within the scope of  
Regulation ( EU) No 2019/1009  of the European 
Parliament and of the Council**;  
(d) food additives within the scope of  Regulation 
(EC) No 1333/2008  of the European Parliament and 
of the Council***; 
(e) in vitro diagnostic devices , including devices  
within the scope of  Regulation (EU) 2017/746 . 
5. Paragraph 1 shall not apply to the placing on the 
market of  the following synthetic polymer 
microparticles :  
(a) synthetic polymer microparticles  which are 
contained by technical means so that releases to the  
3 
 environment  are prevented when used in accordance 
with the instructions  for use during the intended end 
use;  
(b) synthetic polymer microparticles  the physical 
properties  of which  are permanently modified  
during intended end use in such a way  that the 
polymer no longer falls within the scope of this 
entry ;  
(c) synthetic polymer microparticles  which are 
permanently incorporated into a solid matrix  during 
intended end use.  
6. Paragraph 1 shall apply as follows  regarding  the 
following uses :  
(a) from… [OP please insert the date: 6 years after 
the entry into force of this amending Regulation ] to 
synthetic polymer microparticles  for use in the 
encapsulati on of  fragrances;  
(b)  from …[OP please insert the date: 4 years after 
the entry into force of this amending Regulation ] for 
‘rinse -off products ’ as defined in  point (1)(a) of the 
Preamble to Annexes II to VI to Regulation (EC) No 
1223/2009  unless  such products are  covered by 
point (a) of this paragraph  or contain synthetic 
polymer microparticles for use as an abrasive, i.e. 
namely to exfoliate, polish or clean (‘microbeads’) ;  
(c) from… [OP please insert the date: 12 years 
after the entry into force of this amending 
Regulation ] for lip products as defined in point 
(1)(e) of the Preamble to Annexes II to VI to 
Regulation (EC) No 1223/2009, nail products as 
defined in point (1)(g) of the Preamble to Annexes 
II to VI to that Regulation , and make -up within the 
scope of that Regulatio n, unless  such products are  
covered by point s (a) or (b) of this paragraph  or 
contain microbeads ; 
(d) from … [OP please insert the date: 6 years after 
the entry into force of this amending Regulation ] for 
leave -on products , as defined in  point (1)(b) of  the 
Preamble to Annexes II to VI to Regulation (EC) No  
4 
 1223/2009 , unless such products are covered by 
point s (a) or (c) of this paragraph ;  
(e) from …  [OP please insert the date: 5 years after 
the date of  entry into force of this amending 
Regulation ] for detergents , as defined  in Article 2(1) 
of Regulation (EC) No 648/2004 , waxes, polishes 
and air care products , unless those products are 
covered by point (a) of this paragraph  or contain 
microbeads ;  
(f) from … [OP please insert the date  = 6 years after 
the date of entry into force of this amending 
Regulation ] for ‘devices ’, within the scope of 
Regulation (EU) 2017/745 , unless those devices  
contain microbeads ; 
(g) from … [OP please insert the date  = 5 years 
after the date of entry into force of this amending 
Regulation ] for ‘fertilising products ’, as defined in 
Article 2 , point (1), of Regulation (EU) 2019/1009 , 
which  do not fall within the scope of  that 
Regulation ;  
(h) from … [OP please insert the date  = 8 years 
after the date of entry into force of this amending  
Regulation ] for plant protection products within the 
meaning of Article 2(1) of  Regulation (EC) No 
1107/2009****, and biocidal products as defi ned in 
Article 3(1) , point (a), of Regulation (EU) 528/2012  
of the European Parliament and of the Council*****;  
(i) from … [OP please insert the date  = 5 years after 
the date of entry into force of this amending 
Regulation ] for products for agricultural and 
horticultural uses not covered by point s (g) or (h);  
(j)  from … [OP please insert the date  = 6 years 
after the date of entry into force of this amending 
Regulation ] for granular infill for use on synthetic 
sports surfaces . 
7. From … [OP please insert the date  = 24 months  
after the date of entry into force of this amending 
Regulation ] supplier s of products containing 
synthetic polymer microparticles  referred to in   
5 
 paragraph 4 , points  (d) and (e), and suppliers of 
synthetic polymer microparticles  referred to in 
paragraph 5 shall provide  instructions for use  and 
disposal  to avoid releases of synthetic polymer 
microparticles  to the environment .  
From…  [OP please insert the date = 24 months 
after the date of entry into force of this amending 
Regulation ] supplier s of synthetic polymer 
microparticles  referred to in paragraph 4 , point (a), 
shall provide the following  information : 
(a) instructions for use and disposal to avoid 
releases of synthetic polymer microparticles  to 
the environment;  
(b) the following  statement : ‘The synthetic 
polymer microparticles  supplied is subject to 
conditions  laid down by  entry [ OP please insert 
the number  of the entry in point (1) of the Annex ] 
of Annex XVII to Regulation (EC) 1907/2006  of 
the European Parliament and of the Council ’; 
(c) the information on quantity or , as applicable,  
concentration of synthetic polymer microparticles  
in the substance or mixture;  
(d) information on the polymers contained in the 
substance or mixture that enables downstream 
users and other suppliers to comply with their 
obligations laid down  in paragraph  8. 
From… [OP pleas e insert the date = 8 years after 
the date of entry into force of this amending 
Regulation ] until… [OP please insert the date = 12 
years – 1 day after the date of entry into force of this 
amending Regulation ] suppliers of products 
containing synthetic polymer microparticles referred 
to in paragraph 6, point ( c), shall provide the 
following statement : ‘This product contains 
microplastics .’  
The information referred to in the first, second and 
third subparagraphs of this paragraph  shall be 
provided in the form of clearly visible, legible and 
indelible text or, where appropriate  regarding the 
information in the first and second subparagraphs , in  
6 
 the form of pictograms . The text or, where 
appropriate, pictograms, shall be placed  on the label , 
the packaging , the safety data sheet , or the package 
leaflet  of the products containing synthetic polymer 
microparticles . In addition to the text or , where 
appropriate,  pictograms , suppliers may provide a 
digital tool that gives access to a n electronic version 
of that information .  
Where instructions for use and disposal are provided 
in accordance with this paragraph in the form of a 
text, the y shall be in the official languages of the 
Member States where the substance or mixture is 
placed on the market, unless the Member States 
concerned provide otherwise.   
8. Starting f rom… [OP please insert the calendar 
year in which the date 24 months after  the date of 
entry into force of this amending Regulation falls. 
However, if this calculated date is later in the year 
than 31 May, please insert the following calendar 
year.] manufacturers and industrial downstream 
users of synthetic  polymer microparticle s in the 
form of pellets, flakes, and powders used as 
feedstock in plastic manufacturing  at industrial sites , 
and, starting from … [OP please insert the calendar 
year in which the date 36 months after the date of 
entry into force of this amending Regulation falls. 
However, if this calculated date is later in the year 
than 31 May, please insert the following calendar 
year.], other  industrial downstream user s using 
synthetic polymer microparticles  at industrial sites  
shall submit  the following inform ation  to the 
Agency by 31 May of each year:  
(a) a description of the use s 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  
7 
 environment in the previous calendar year.  
From … [OP please insert the calendar year in 
which the date 36 months after t he 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 ], supplier s 
of products containing synthetic polymer 
microparticles referred to in paragraphs 4, points 
(b), (d) and (e) , placed on the market for the first 
time, and suppliers of synthetic polymer 
microparticles  referred to in paragraph 5 placed on 
the market for the first time shall submit  the 
following information  to the Agency by 31 May of 
each year : 
(a) a description of the end uses for which the 
synthetic polymer microparticles  were placed on 
the market in the previous calendar year ;  
(b) for each end use for which the synthetic 
polymer microparticles were placed on the 
market, generic information on the identity of the 
polymers placed on the market  in the previous 
calendar year ;  
(c) for each end use  for which the synthetic 
polymer microparticles were placed on the 
market , an estimate of the quantity of synthetic 
polymer microparticles  released to the 
environment in the previous calendar year.  
  
* Regulation (EU) 2019/6 of the European 
Parliament and of the Council of 11 December 2018 on 
veterinary med icinal 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 a mending 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).  
8 
 *** Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council of 16 December 2008 on 
food additives (OJ L 3 54, 31.12.2008, p. 16).   
**** Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on 
the market and repealing Council Directives 79/117/EEC 
and 91/414/EEC (OJ L 3 09, 24.11.2009, p. 1).  
***** Regulation (EU) No 528/2012 of the European 
Parliament and of the Council of 22 May 2012 
concerning the making available on the market and use 
of biocidal products (OJ L 167, 27.6.2012, p. 1). ’ 
 
 
 
 (2) the following Appendi ces  …  and … [ OP: please insert the number s of the Appendi ces]  
are added:  
‘Appendix …  
Entry [ OP please insert the number  of the entry  in point (1) of the Annex ] – Rules on 
proving  degradability  
This appendix lays down the rules for proving degradability of polymers for the purposes of  
entry [ OP, please insert the number  of the entry  in point (1) of the Annex ], namely the 
permitted test methods and the pass criteria for those methods.  The test methods were 
designed to measure biotic degradation, although it cannot be excluded that some abiotic 
degradation takes place during the test and contributes to the test results.  
The tests shall be conducted by laboratories complying with the principles of good laboratory 
practice provided for in Directive 2004/10/EC  or other international standards recognised as 
being equivalent by the Commission or the Agency or accredited to ISO 17025.  
 
1. Test methods  
The permitted test methods are organised into five groups, on the basis of their design and 
underlying rationale. Mee ting the pass criteria in any of the permitted test methods in groups 
1 to 3 is sufficient to demonstrate that the polymer or polymers contained in the tested 
material and subject to the test are degradable  and are therefore excluded from the scope of 
entry [OP, please insert the number  of the entry in point (1) of the Annex ]. Where group 4 or 
group 5 tests are used to demonstrate degradability of polymers for uses other than  
9 
 agricultural and horticultural uses, the pass criteria shall be met in at least th ree of the 
following environmental compartments:  
- fresh or estuarine water,  
- fresh or estuarine water sediment,  
- marine water,  
- marine sediment,  
- marine water/sediment interface,  
- soil. 
 
2. Group 1. Screening test methods and pass criteria to demonstrate ready biodegradation  
2.1. Permitted test methods in group 1:  
T1. ‘Ready Biodegradability’ (OECD TG 301 B, C, D, F)  
T2. ‘Ready Biodegradability – CO 2 in sealed vessels (Headspace Test)’ (OECD TG 310).  
2.2. Pass criteria: 60% mineralisation measured , over 28 days , as evolved CO 2 or 
consumed O 2. The 10 -day window requirement mentioned in the T1 and T2 test guidelines 
does not need to be fulfilled.  
3. Group 2. Modified and enhanced screening test methods and pass criteria to demonstrate 
ready biodegradation   
3.1. Permitted test methods in group 2:  
T1. ‘Ready Biodegradability’ (OECD TG 301 B, C, D, F);  
T2. ‘Ready Biodegradability – CO 2 in sealed vessels (Headspace Test)’ (OECD TG 310);  
T3. ‘Biodegradability in Seawater’ (OECD TG 306).  
 
3.2. For group 2 test me thods, the test duration can be extended to up to 60 days and larger 
test vessels used.  
3.3. Pass criteria: 60% mineralisation measured , over  60 days , as consumed O 2 (allowed 
for T1 and T2 tests only) or evolved CO 2. The 10 -day window requirement mentioned  in the 
T1 and T2 test guidelines does not need to be fulfilled.  
4. Group 3. Screening test method and pass criteria to demonstrate inherent degradation   
4.1. Permitted test method in group 3:  
T4. ‘Inherent Biodegradability: modified MITI Test (II)’ (OECD 30 2C).  
4.2. The pre -adaptation of the inoculum mentioned in the T4 test guideline shall not be 
allowed.   
10 
 4.3. Pass criteria: ≥ 70% mineralisation measured as consumed O 2 or evolved CO 2 within 
14 days.  
5. Group 4. Screening test methods and pass criteria to demonstrate degradation relative to a 
reference material  
5.1. Permitted test methods in group 4:  
T5. ‘Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous 
medium – Method by analysis of evolved carbon dioxide.’ (EN ISO 14852:2018);  
T6. ‘Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous 
medium – Method by measuring the oxygen demand in a closed respirometer.’ (EN ISO 
14851:2004) ;  
T7. ‘Plastics – Determination of aerobic biodegradation of non -floating plastic materials in 
seawater/sediment interface – Method by analysis of evolved carbon dioxide’ (EN ISO 
19679:2016);  
T8. ‘Plastics – Determination of aerobic biodegradation of non -floating plastic materials in 
seawater/sandy sediment interface  – Method by measuring the oxygen demand in closed 
respirometer’ (EN ISO 18830:2016);  
T9. ‘Plastics – Determination of the ultimate aerobic biodegradability of plastic materials in 
soil by meas uring the oxygen demand in a respirometer or the amount of carbon dioxide 
evolved’  (EN ISO 17556:2019);  
T10. ‘Plastics - Determination of the aerobic biodegradation of non -floating materials 
exposed to marine sediment – Method by analysis of evolved carbon  dioxide’ (ISO 
22404:2019).  
5.2. The specifications laid down in ISO 22403:2020 ‘Plastics – Assessment of the 
intrinsic biodegradability of materials exposed to marine inocula under mesophilic aerobic 
laboratory conditions – Test methods and requirements’  shall be taken into account when 
applying T7 and T8.  
 
5.3. For group 4 test methods, the pre -adaptation of the inoculum shall not be allowed. 
The result shall be reported as the maximum level of degradation determined from the plateau 
phase of the degrada tion curve, or as the highest value if the plateau has not been reached. 
The form, size and surface area of the reference material shall be comparable to that of the 
test material. The following materials may be used as reference materials:  
- positive contro ls: biodegradable materials such as micro -crystalline cellulose powder, 
ashless cellulose filters or poly -β-hydroxybutyrate.  
- negative controls: non -biodegradable polymers such as polyethylene or polystyrene.  
5.4. Pass criteria: ultimate degradation of ≥ 9 0% relative to the degradation of the 
reference material within:  
- 6 months in aquatic tests, or,  
- 24 months in soil, sediment or water/sediment interface tests.   
11 
  
6. Group 5. Simulation test methods and pass criteria to demonstrate degradation under 
relevant env ironmental conditions  
6.1. Permitted test methods in group 5:  
T11. ‘Aerobic and Anaerobic Transformation in Soil’ (OECD TG 307)  
T12. ‘Aerobic and Anaerobic Transformation in Aquatic Sediment Systems’ (OECD TG 308)  
T13. ‘Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test’ (OECD 
TG 309)  
6.2. The required test temperatures shall be 12 °C for fresh/estuarine water, fresh/estuarine 
water sediment and soil, and 9 °C for marine water and marine sedim ent because these are 
the average temperatures for that compartment in the Union.  
6.3. Pass criteria:  
- the degradation half -life in marine, fresh or estuarine water is less than 60 days;  
- the degradation half -life in marine, fresh or estuarine sediment is less than 180 
days;  
- the degradation half -life in soil is less than 180 days.  
 
7. Specific requirements for demonstrating the degradability of polymers in products 
for agricultural and horticultural applications  
Where group 4 or group 5 test methods are used, the  degradability of polymers in products 
for agricultural or horticultural applications shall be demonstrated in at least two 
environmental compartments chosen as follows:  
Compartment 1: fresh, estuarine or marine water;  
Compartment 2: soil.  
To be c onsidered degradable for the scope of entry [ OP please insert the  number  of the entry 
in point (1) of the Annex ], a polymer in a product for agricultural or horticultural applications 
shall achieve 90 % degradation in: 
(a) soil within 48 months after the end of that product functionality period; the 
functionality period is the time following the product application during which the 
product exerts its function.  
(b) water within:  
(i) 12 months plus 1/4 of the product functionality period, where group 4 test 
methods are  used; or  
(ii) 16 months plus 1/3 of the product functionality period, where group 5 test 
methods are used.   
12 
 To this end, the pass criteria for group 4 and 5 test methods shall be modified to indicate the 
percentage of degradation (for group 4) or the half -life (for group 5) that needs to be observed 
at the end of the standard test duration in order to achieve the conditions laid down in the 
previous paragraph.  
The modified pass criteria of group 4 and 5 test methods are set in Tables A and B, 
respectively.  
Table A: Group 4 pass criteria for polymers in products for agricultural or horticultural 
applications, listed by duration of the functionality period (FP) and type of test.  
Test method  Criterion 
assessed  Pass 
criterion 
(FP=0)  Pass 
criterion 
(1 month 
FP) Pass 
criterion 
(2 month 
FP) Pass 
criterion 
(3 month 
FP) Pass 
criterion 
(6 month 
FP) Pass 
criterion 
(9 month 
FP)  Pass 
criterion 
(12 
month 
FP) Pass 
criterion 
(18 
month 
FP) Pass 
criteri
on (24 
month 
FP) 
T9 (soil)  % of ultimate 
degradation 
relative to the 
degradation 
of the 
reference 
material after 
24 months  
≥ 68%  ≥ 67,5%  ≥ 67%  ≥ 66%  ≥ 64%  ≥ 62%  ≥ 60%  ≥ 57%  ≥ 54%  
T5 and T6  
(water)  % of ultimate 
degradation 
relative to the 
degradation 
of the 
reference 
material after 
6 months  
 
Table B: Group 5 pass criteria for polymers in products for agricultural or horticultural 
applications, listed by duration of the functionality period (FP) and type of test.  
Test 
method  Criterion 
assessed  Pass 
criterion 
(FP=0)  Pass 
criterion 
(1 month 
FP) Pass 
criterion 
(2 month 
FP) Pass 
criterion 
(3 month 
FP) Pass 
criterion 
(6 month 
FP) Pass 
criterion 
(9 month 
FP)  Pass 
criterion 
(12 month 
FP) Pass 
criterion 
(18 month 
FP) Pass 
criterion 
(24 month 
FP) 
T11  Half-life 
(DT50) 
observed at 
the end of 
the Half-life 
≤ 440 
days  Half-life 
≤ 449 
days  Half-life 
≤ 458 
days  Half-life 
≤ 467 
days  Half-life 
≤ 495 
days  Half-life 
≤ 522 
days  Half-life ≤  
550 days  Half-life ≤  
605 days  Half-life ≤ 
660 days   
13 
 standard 
test 
duration  
T13 Half-life 
(DT50) 
observed at 
the end of 
the 
standard 
test 
duration  Half-life 
≤ 147 
days  Half-life 
≤ 150 
days  Half-life 
≤ 153 
days  Half-life 
≤ 156 
days  Half-life 
≤ 165 
days  Half-life 
≤ 174 
days  Half-life ≤  
183 days  Half-life ≤  
202 days  Half-life ≤ 
220 days  
 
In case the duration of the functionality period falls in between two values of Tables A or B, 
the applicable pass criterion shall be the more stringent of the two.  
 
8. Specific requirements for the test material to be used in degradation tests  
The test material shall be comparable in terms of composition, form, size and surface area to 
the polymer particles present in the product or, if not technically feasible, to the particles that 
are disposed or released to the environment. Comparability is important as the composition, 
form, size and surface area of particles affect the degradation behaviour.  
Polymers used for encapsulation may be tested:  
- in the form placed on the market, or,  
- in the form of isolated coating, or,  
- in the form placed on the ma rket where the organic core of the material is replaced 
by an inert material such as glass.  
The test material shall be of comparable thickness to the solid polymer coating of the particle 
placed on the market. When the degradation is assessed in relation to a reference material , as 
referred to  in point  5.3., the form, size and surface area of the reference material shall be 
comparable to that of the test material. Where the test material is a blend of more than one 
polymer, the degradation of the blend as well as that of each of the polymers in the blend 
shall be demonstrated. This shall be done by:  
- separately testing the degradation of the blend and of each polymer in the blend 
using the permitted test methods and pass criteria set out in this Appendix, o r,  
- demonstrating, by any appropriate means, that all polymers in the blend contribute 
to the degradation observed during testing and that each polymer meets the pass 
criteria in the relevant permitted test method.  
  
14 
  
Appendix [OP: please insert the number of the Appendix ]] 
Entry [ OP, please insert the number  of th e entry  in point (1) of the Annex ] - Rules on 
proving  solubility:  
This appendix lays down the permitted test methods and the test conditions to prove that a 
polymer is soluble for the purpose s of entry [ OP, please insert the number  of the entry in 
point (1) of the Annex ]. The tests shall be conducted by laboratories complying with the 
principles of good laboratory practice provided for in Directive 2004/10/EC or other 
international standards re cognised as being equivalent by the Commission or the Agency or 
accredited to ISO 17025.  
Permitted test methods:  
1. OECD Guideline 120  
2. OECD Guideline 105  
The test material shall be comparable in terms of composition, form, size and surface area to 
the polymer  particles present in the product. For polymeric particles containing inorganic 
elements, such as particles encapsulated with inorganic substances or particles where the 
polymer is grafted onto an inorganic carrier, it shall be sufficient to demonstrate th at the 
polymeric part of the particle meets the pass criteria. This may require the testing of the 
polymer(s) prior to the formation of the particle.  
The conditions for the solubility test shall be the following:  
- Temperature 20 ⁰C  
- pH 7  
- Loading: 10 g/1000 mL  
- Test time: 24 h’