Amendments to Regulation (EU) No 10/2011
1. Article 2, paragraph 3 is replaced by the following:
‘3. This Regulation shall be without prejudice to Union or national provisions applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles.’
.
2. Article 3 is amended as follows:
(1)
point (7) is replaced by the following:
‘(7)
“additive” means a substance which is intentionally added to the plastic to achieve a physical or chemical effect during processing of the plastic or in the final material or article and it is intended to be present in the final material or article, including substances in a solid state the surface of which becomes bonded to the polymers that constitute the plastic.’;
(2)
the following points are added:
‘(20)
“reprocessing of plastic” means the remelting, mixing, reacting or otherwise processing of plastic materials that result as a by-product from an intermediate or final manufacturing operation in the manufacture of plastic materials and articles, alone or combined with material originating from other manufacturing operations, by applying, if necessary, transfer and operations to make the use of these by-products possible again.
(21)
“UVCB substance” means a substance of unknown or variable composition, complex reaction products or a material of a biological or other natural origin.’.
3. A new Article 3a is added:
‘Article 3a
High degree of purity
A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents correspond to its identity, and it otherwise contains only a minor amount of non-intentionally added substances that individually fulfil one of the following conditions:
(i)
they comply with the specifications or restrictions specified in the authorisation of the substance in Table 1 of Annex I, if any;
(ii)
they have been subject to a risk assessment in accordance with Article 19 and considered compliant;
(iii)
they have been subject to a toxicological assessment in accordance with the relevant guidance adopted by the Authority, which concludes that genotoxicity is ruled out, and that, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, it can be reasonably assumed that none of the substances will be present in the final plastic material or article at a level that could give rise to a migration such as to their individual presence in food exceeding 0,05 mg/kg;
(iv)
they have not been subject to an assessment specified in points (ii) or (iii), but to a risk assessment which concludes, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, that it can be reasonably assumed that they cannot be present in the final plastic material or article at a level that could give rise to a migration into food such as to their individual presence in food exceeding 0,00015 mg/kg.
For the purpose of point (iii), the individual assessment of genotoxicity may be substituted with a group assessment of genotoxicity, if the assessed substances are chemically related and belong to the same or similar functional groups that could give rise to toxicity, or if the substances are obtained as a mixture representative for migration into food and this mixture is assessed through appropriate methods.’
.
4. In Article 4, the following point is added:
‘(f)
comply with Commission Regulation (EU) 2022/1616 ( *1 ) if they fall within the scope of that Regulation.
5. In Article 5, paragraph 1 is replaced by the following:
‘1. Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be used in the manufacture of plastic materials and articles.’
.
6. In Article 5, the following paragraph is added:
‘4. In case of doubt over the resulting designated identity of a substance, a Member State or the Commission may consult the Authority.’
.
7. Article 6 is amended as follows:
(1)
paragraph 1 is replaced by the following:
‘1. By way of derogation from Article 5, substances other than those included in the Union list may be used as polymer production aids in the manufacture of plastic materials and articles subject to national law.’
;
(2)
paragraph 2 is replaced by the following:
‘2. By way of derogation from Article 5, colorants and solvents may be used in the manufacture of plastic materials and articles subject to national law.’
;
(3)
paragraph 4 is replaced by the following:
7.‘4. The following substances not included in the Union list may be present in plastic materials or articles:
(a)
non-intentionally added substances;
(b)
aids to polymerisation.’
;
(4)
paragraph 5 is replaced by the following:
‘5. By way of derogation from Article 5, substances with a biocidal function used in biocidal products that may be made available on the Union market in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council ( *2 ) for product-type 4 for use that covers incorporation into plastic materials and articles which may enter into contact with food, may be used as additives in the manufacturing of plastic materials and articles.
( *2 ) 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 , ELI: http://data.europa.eu/eli/reg/2012/528/oj ).’."
8. Article 7 is deleted.
9. Article 8 is replaced by the following:
‘Article 8
General requirements on substances
1. Substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste, shall be of a high degree of purity and shall be of a technical quality suitable for the intended and foreseeable use of the materials or articles.
The composition shall be known to the manufacturer of the substance.
2. By derogation from paragraph 1, as regards purity, UVCB substances that are identified by a name in this Regulation that refers to a natural multi constituent material the source of which is biological or mineral, may be used as obtained from their natural origin, provided they do not contain substances or materials that do not correspond to its identity as designated by that name. Any additional specifications or requirements applicable to a substance or material of natural origin set out in Table 1 of Annex I, applicable to the substance or material, shall apply.’
.
10. In Article 9, paragraph 1, the phrase ‘plastic layers in’ is deleted.
11. Article 10 is replaced by the following:
‘Article 10
General restrictions and requirements concerning the composition of plastic materials and articles
1. Plastic materials and articles shall meet the restrictions on plastic materials and articles laid down in Annex II.
11.2. Plastic materials and articles may contain reprocessed plastic if such reprocessed plastic meets the following conditions:
(a)
it is a by-product in accordance with Article 5 of Directive 2008/98/EC of the European Parliament and of the Council ( *3 ) ;
(b)
it is collected and used in accordance with section C of the Annex to Regulation (EC) No 2023/2006;
(c)
it originates from one of the following off-cuts and scraps from plastic materials and articles:
(i)
off-cuts and scraps from plastic materials and articles referred to in point (a) of Article 2(1) that meet the compositional requirements set out in Chapter II of this Regulation, or
(ii)
off-cuts and scraps from plastic materials and articles referred to points (b) and (c) of Article 2(1), provided that such reprocessed plastic does not contain a layer which functions as a functional barrier and all of its individual constituents either meet the compositional requirements set out in Chapter II of this Regulation, or have been subject to risk assessment on the basis of Article 19 taking into account the conditions of reprocessing and their presence in the reprocessed material;
(d)
it does not contain substances in an amount which could:
(i)
exceed migration limits applicable for the substance as specified in this Regulation; or
(ii)
cause any other non-compliance of those plastic materials and articles with Article 3 of Regulation (EC) No 1935/2004.
3. Where intended for repeated use in contact with food, the composition and the design of final food contact articles shall be such, so as to guarantee that no increase in the migration of constituents of the material or article to the food would occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labelling.
12. Article 13 is amended as follows:
(1)
in point (b) of paragraph 2, the phrase ‘in the provisional list’ is deleted;
(2)
in paragraph 4 the phrase ‘or provisional list’ is deleted.
13. The title of Chapter IV is replaced by the following:
‘LABELLING, DECLARATION OF COMPLIANCE AND DOCUMENTATION’.
14. A new Article 14a is added:
‘Article 14a
Labelling
14.1. The manufacturer or other operator responsible for placing on the market a final plastic food contact article intended for repeated use, shall provide to its users in accordance with Articles 15(7) and (8) of Regulation (EC) No 1935/2004 the following:
(a)
appropriate instructions designed to slow down deterioration of the article;
(b)
a description of observable changes of the article that may indicate the deterioration of the article or material;
(c)
a warning in case specific damages or foreseeable misuse would cause increased migration or would cause the article to become otherwise unsuitable for further use in contact with food.
14.2. Plastic materials and articles intended to be brought into contact with food but which are not yet in contact with it shall be accompanied at the moment of their sale or supply to consumers at retail stage with instructions of use, in accordance with Article 15(1) of Regulation (EC) No 1935/2004, directed at the consumer of that final food contact article, where they are manufactured with substances included in the Union list of authorised substances, for which column 10 of Table 1 of Annex I sets out restrictions related to one or more of the following elements:
—
specific foods or groups of foods,
—
contact time and/or temperature, and/or
—
heating conditions such as oven and microwave use.
The instructions of use shall mention the restrictions and provide the consumer with adequate information to avoid using the article under conditions not complying such restrictions.’.
15. Article 14 is amended as follows:
(1)
in paragraphs 2 and 3, the phrase ‘or the provisional list’ is deleted;
(2)
paragraph 4 is replaced by the following:
‘4. Articles 11 and 12 apply to multi-material multi-layer materials and articles when the surface layer that is in contact with food is made of a material falling within the scope of this Regulation.’
;
(3)
paragraph 6 is replaced by the following:
‘6. If the surface layer that is in contact with food is made of a material falling not within the scope of this Regulation, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.’
.
16. Article 16 is replaced with the following:
‘Article 16
Supporting documents
1. Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request.
For substances used in the manufacture of plastic materials and articles, documentation on the composition shall be made available to the competent authorities on request, together with any documentation regarding their degree of purity.
2. That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out in Chapter V.
3. Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that documentation showing compliance with paragraphs 1 to 2 of Article 8 is part of the documentation referred to in paragraph 1.
4. Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that competent authorities can take samples during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used for their manufacture.’
.
17. In Article 17, paragraph 2 is replaced with the following:
17.‘2. By derogation from paragraph 1, a surface to volume ratio equal or higher than 6 dm 2 per kg of food may be applied for the following materials and articles:
(a)
containers and other articles, containing or intended to contain a volume of less than 500 ml or more than 10 litres;
(b)
a material or article for which, due to its form, it is impracticable to estimate the relationship between its surface area and the quantity of food in contact therewith;
(c)
sheets and films that are not yet in contact with food;
(d)
for sheets and films containing a volume less than 500 ml, or more than 10 litres.
This paragraph does not apply to plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council ( *4 ) .
18. Annexes III to V are amended in accordance with Annex I to this Regulation.
ANNEX ISupplementary provisions
ANNEX I
Annexes III to V to Regulation (EU) No 10/2011 are amended as follows:
(1)
in Table 2 of Annex III, the descriptions and simulant assignments for cheeses with reference number 07.04 are replaced by the following:
(1)
(2)
(3)
Reference number
Description of food
Food simulants
A
B
C
D1
D2
E
‘07.04
Cheeses:
A. Whole cheese with inedible rind
X’
B. Unripened soft cheese (fresh cheese), e.g. cottage cheese, quark, ricotta, cream cheese, fromage frais, and similar cheeses
X (*)
X
C. Sliced ripened soft, firm or hard cheese or whole with edible rind, e.g. gouda, cheddar, gruyère, parmesan, stilton, tallegio, beaufort, tomino, brie, camembert, and similar cheeses
X/3
D. Processed cheese, e.g. wedges, spreads and slices
X/3
E. Brined or fresh cheese in a liquid medium e.g. feta and mozzarella:
I. in an oily medium
X
II. in an aqueous medium
X (*)
X
(2)
Annex IV is amended as follows:
(a)
point 6 is replaced by the following:
‘6.
adequate information allowing the downstream business operators to ensure compliance with this Regulation relative to the substances used for which restrictions and/or specifications are set out in Annexes I and II, including adequate information on the presence of non-intentionally added substances if present in an amount that could cause non-compliance of a final material with Article 3 of Regulation (EC) No 1935/2004.
At intermediate stages, this information shall include the identification and amount of the following substances contained in the intermediate material:
—
substances that are subject to restrictions and/or specifications in Annex II, or
—
substances for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to an individual migration into food from the final plastic material or article exceeding 0,00015 mg/kg food;’;
(b)
points 10 and 11 are added:
‘10.
when the plastic material is a batch of material intended for reprocessing:
(a)
the confirmation that it complies with Articles 10(1) and 10(2) of this Regulation and that it has been collected and used in accordance with point C of the Annex to Regulation (EC) No 2023/2006; and
(b)
as appropriate, a specification of its composition and instructions for reprocessing;
11.
when the plastic material has been manufactured with one or more substances included in the Union list of authorised substances in accordance with Article 5 of this Regulation that have been manufactured from waste, a confirmation that the substances used are compliant with point (1) of Article 8 of this Regulation.’;
(3)
Annex V is amended as follows:
(a)
The introductory part on compliance testing preceding Chapter 1 is replaced by the following:
‘
COMPLIANCE TESTING
For testing compliance of migration from plastic food contact materials and articles, an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *1 ) shall be selected, applying the following specific performance criteria:
(i)
The analytical method working range of analytical methods shall be at least R L × SML to R U × SML, as described in the relevant guidance documents, where
—
R L is the relative lower method working range threshold,
—
R U is the relative upper method working range threshold,
—
R U shall be 2. R L shall be 0,2 unless 0,2 × SML is below the analytical limit of quantification (LOQ) of the substance then the R L × SML is set at the LOQ of the substance.
(ii)
Prior to the verification of compliance with a SML, the specific migration test result, m , needs to be corrected, if relevant: (1) by the real surface-to-volume ratio ((S/V) real ) and the surface-to-volume ratio (S/V) test in accordance with Article 17; and/or (2) by the correction factor (C T2 ) used in the sub-columns for the food simulants D2 and E in Table 2 of Annex III to Regulation (EU) No 10/2011; and/or (3) by the FRF in accordance with point 4.1 of this Annex. When the results are corrected in application of C T2 in combination with the FRF, in accordance with point 4.1 in Annex V, the combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.
(iii)
The reproducibility coefficient of variation CV R , which can be expressed in percentage if multiplied by 100, is used to calculate the relative standard measurement uncertainty with the purpose to evaluate compliance. The formulas for calculating the CV R are as follows:
CV R = 0,22 for m c
<0,12 × 10 -6 kg /kg; and,
CV R = 2 (1-½log(m c )) /100 for 0,12 × 10 -6 kg/kg ≤ m c
≤ 0,138 kg/kg.
Where m c
is the specific migration test result of a substance or, if relevant, the corrected specific migration result that is to be evaluated against the SML set out in this Regulation, the standard measurement uncertainty of m c
of a substance, u( m c
), shall be determined as follows: u( m c
) = CV R × m c
.
(iv)
The compliance with the SML shall then be evaluated by applying the following specific performance criterion, where m c
is to be evaluated against the SML:
If ( m c
- SML)/[(u( m c
)] > 1,64, then m c
exceeds the SML.
If m c
is higher than the SML the m c
of a substance shall be considered non-compliant. In addition, the rules in Chapter 1-4 of this Annex shall apply.
( *1 ) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) ( OJ L 95, 7.4.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/625/oj ).’;"
(b)
in Chapter 2 of Annex V, point 2.1.6 of is replaced by the following:
‘If the material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. Compliance of the material or article shall then be verified on the basis of the level of the specific migration observed in the third migration test and on the basis of the stability of the material or article. The specific migration observed in the second migration test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.
For the purpose of the first paragraph, the sample shall be considered non-compliant if:
m c,
3 >SML, or,
m c,
1 < m c,
2 , or,
m c,
2 < m c,
3 , or,
m c,
1 < m c,
3 ,
where m c,
1 , m c,
2 , and m c,
3 are respectively the m c
during the first, the second and the third migration test carried out in accordance with the first subparagraph.
The compliance with the SML and the stability rule shall be evaluated applying the following criteria:
—
If ( m c,
3 – SML)/[(u( m c,
3 )] > 1,64, then the third migration is higher than the SML,
—
If ( m c,
2 – m c,
1 )/[(u( m c,
2 ) + u( m c,
1 )] > 1,64, then the first migration is smaller than the second migration,
—
If ( m c ,
3 – m c,
2 )/[(u( m c,
3 ) + u( m c,
2 )] > 1,64, then the second migration is smaller than the third migration,
—
If ( m c,
3 – m c,
1 )/[(u( m c,
3 ) + u( m c,
1 )] > 1,64, the first migration is smaller than the third migration.
In case m c
is smaller than R L × SML, the m c
shall be considered equal to R L × SML. This m c
shall be used for determining the corresponding standard measurement uncertainty of the m c
and for evaluating the compliance with the performance criteria set out in this point.
However, if there is scientific proof that the level of the specific migration is not increasing as described in the second paragraph above in the course of the second and third migration tests and if the SML is not exceeded during the first migration test, the material or article is considered compliant with the SML laid down in this Regulation.
Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation where in any of the migration tests a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) of this Regulation is detected.’;
(c)
in Chapter 2 of Annex V, text of point 2.1.7 is replaced by the following:
‘At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the applicable performance criteria laid down in this Annex.’;
(d)
in Chapter 3 of Annex V, text of point 3.3.2 is replaced by the following:
‘The applicable overall migration test shall be carried out three times on a single sample using a different portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found during the third test and on the basis of the stability of the material or article i.e. the overall migration during the second test shall not exceed the level observed in the first test, and the overall migration in the course of the third test shall not exceed the level observed during the second test. The compliance shall be evaluated in accordance with the specific performance criteria described in point 2.1.6 in Chapter 2 of Annex V. However, the standard measurement uncertainty of the analytical method as determined by the laboratory shall be used to determine u( m), instead of the standard measurement uncertainty derived on the basis of the approach as specified in the introductory part on compliance testing preceding Chapter 1.
If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The first migration, the difference between the second and the first migration and the difference between the third and the second migration shall be considered to represent the three successive overall migrations.
However, if there is scientific proof that the level of the migration, as described in point 2.1.6 in Chapter 2 of Annex V, is not increasing during the second and third migration tests and if the migration limit is not exceeded in the course of the first migration test, the material or article is considered compliant with the overall migration limit.’.
( *1 ) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) ( OJ L 95, 7.4.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/625/oj ).’;’
ANNEX IISupplementary provisions
ANNEX II
The Annex to Regulation (EC) No 2023/2006 is amended as follows:
(1)
the title of section B and point 1 thereof are replaced by the following:
‘B. Minimum requirements for a quality assurance system to be operated at recycling facilities, where recycled plastic is manufactured in accordance with Regulation (EU) 2022/1616
1.
The quality assurance system implemented by the recycler must give adequate confidence in the ability of all recycling operations taking place at the facility to ensure the recycled plastic meets the requirements set out in Regulation (EU) 2022/1616.’;
(2)
in section B, the following paragraph is added:
‘3.
The quality assurance system implemented by the recycler shall include specific operations in the recycling process, “Quality Assessment Stages”, at which the recycler shall assess the quality of each batch of material directly originating from a manufacturing stage.
This assessment shall check the quality of that material by verifying:
—
whether the applicable critical limits referred to in point 2, point (c) have been met at each unit operation that is part of the manufacturing stage, and
—
whether the quality of the resulting material meets pre-defined criteria, using the tests, protocols and evidence referred to in point 2, point (e) applicable to the manufacturing stage.
The assessment shall result in a decision on whether the quality of the batch is considered as complying with Regulation (EU) 2022/1616 and suitable for further processing, whether its quality requires correction before further processing or, whether the batch is to be discarded or used for non-food applications.’;
(3)
the following section C is added:
‘C. Reprocessing of plastics falling within the scope of Regulation (EU) No 10/2011
1.
Plastic offcuts, scraps, and similar by-products of plastic manufacturing processes and intended to be reprocessed in accordance with Article 10(2) of Regulation (EU) No 10/2011 (“materials intended for reprocessing”) shall be collected separately from waste as close as technically achievable to the point at which they are cut, scrapped or otherwise produced from a similar plastic manufacturing operation leading to offcuts and scraps and similar by-products of plastic.
2.
Materials intended for reprocessing shall be collected either using a closed piping or belt system intended for that purpose only, or in clean bins, bags, or other containers designated to this purpose and which can easily be recognised as being intended only for this purpose. Those types of containers shall be closed as soon as they are fully filled. Up to the point of reinsertion in the plastic production process the applied containers shall be designed to prevent any contamination of the plastic material.
3.
Such bins, bags or containers may be transferred for reprocessing individually or be grouped in secondary packaging. The resulting unit shall be considered as a batch of material intended for reprocessing. The definition of “batch” in Article 2(3), point (20) of Regulation (EU) 2022/1616 shall apply.
4.
At any stage of the reprocessing of plastic, operators shall ensure that the quality assurance system prevents it from being mixed with plastic of a different composition, other materials, or with waste. The transfer of batches of plastic by-products between operations prior to their use in the manufacturing of plastic materials and articles, including the mixing with plastic of the same composition, shall be recorded and their traceability shall be accounted for in the quality assurance system.’.
