WHITE PAPER

REGULATION (EU) 2020/1245 TO AMEND

REGULATION (EU) NO 10/2011
FOR PLASTIC FOOD CONTACT MATERIALS
MAINTAINING COMPLIANCE
Kathelijn Nafzger, Application Specialist Food Contact, Intertek Polychemlab BV

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REGULATION (EU) 2020/1245 TO AMMEND REGULATION
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CONTENTS
ABSTRACT 2

INTRODUCTION 3

COMMISSION REGULATION (EU) NO 10/2011 – A RECAP 3

AMENDMENT - EUROPEAN COMMISSION REGULATION (EU) 2020/1245 4

NEW ADDITIONS TO THE POSITIVE LIST – AMENDMENT TO ANNEX I 4

SPECIFIC MIGRATION LIMITS - AMENDMENTS TO ANNEX II 5

AMENDMENT TO ANNEX IV 6

COMPLIANCE TESTING - AMENDMENTS TO ANNEX V 6

STEPS TO MAINTAINING COMPLIANCE 7

CONCLUSION 7

REFERENCES 7

MEET OUR AUTHOR 7

ABSTRACT
Commission Regulation (EU) No 10/2011 on plastic materials and articles establishes specific requirements for the manufacture and marketing
of plastic materials and articles. The regulation sets out the rules on the composition and compliance of plastics materials and articles, the Union
List of permitted substances and information on restrictions on the use of these substances. Regulation (EU) 2020/1245 to amend Regulation
(EU) No 10/2011 specifies a date to enter into force of 23 September 2020. In this white paper, our Application Specialist Food Contact,
Kathelijn Nafzger, introduces the Regulation (EU) 10/2011 and highlights some of the more significant amendments.

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REGULATION (EU) 2020/1245 TO AMMEND REGULATION
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Introduction
Commission Regulation (EU) No 10/2011 on plastic materials and articles establishes specific requirements
for the manufacture and marketing of plastic materials and articles1. The regulation sets out the rules on the
composition of plastic food contact materials (FCMs) and establishes an Union List of substances that are
permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use
of these substances and sets out rules to determine the compliance of plastic materials and articles.

Since the enactment of the (EU) 10/2011 regulation, several amendments have been released and
implemented. An amendment (EU) 2019/1338 was published by the Commission Regulation on the 8
August 20192, and looking ahead, Regulation (EU) 2020/12453 which will enter into force on 23 September
2020.

Commission Regulation (EU) No 10/2011 – A recap

The Commission Regulation (EU) No 10/2011 on plastic materials and articles was published in 2011.
It is the most comprehensive “specific measure”, concerning plastic FCMs. It sets out the compositional
requirements in the form of an Union list of substances that can be used and specific provisions for certain
materials and articles that are within its scope. It also broadly defines how to perform compliance testing and
how to document this in a Declaration of Compliance (DoC). It also covers some transitional provisions which
concern the various amendments. All of these topics are discussed in six Annexes with detailed information.

The scope includes plastic mono-layers (such as a films, bottles or caps), plastics multilayers bound by
adhesives, plastic layers or coatings forming gaskets in caps & closures and plastic layers in multi-material
multi-layer materials. All plastics may be coated and/or printed. The contribution of all materials and
substances from inks or coating layers in relation to migration into food needs to be considered to fulfil the
requirements of the (EU) 10/2011 and (EC) 1935/2004. One of the most important parts of (EU) 10/2011
is the compositional requirement which means it states a list of substances which can be used when
producing a plastic FCM – this list, also known as the Union list is outlined in Annex 1. Substances that can be
used are categorised into several groups, among which:

• Monomers – listed in Annex 1

• Additives – listed in Annex 1
• Primary aromatic amines and selected metals such as those used in some catalysts – listed in Annex II

There are also other substances that are authorised, but which are not listed, for instance all salts of
authorised acids, phenols or alcohols and others.

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An important mechanism to ensure the safety of plastic materials is the use of migration limits. There are 2
types of migration limits, the overall migration limit and the specific migration limit. The overall migration limit
means the maximum permitted amount of non-volatile substances released form a material or article into
foodstuffs. The overall migration limit is 10 mg/dm² of the food contact material or 60 mg/ kg food.

The specific migration limit means the maximum permitted amount of a given substance released from a
material or article into food or food simulants. The specific migration limits are included in the Union list.
These are established by EFSA on the basis of toxicity data of each specific substance.

The Regulation sets out detailed migration testing rules. Although migration testing in the food prevails,
migration is usually tested using ‘simulants’. These simulants are representative for a food category, e.g.
Acetic acid 3 % (w/v) is assigned for acidic foods. The migration testing is conducted under standardised
time/temperature conditions, representative for a certain food use, and covers the maximum shelf life of
packed food.

To ensure the safety, quality and compliance of plastic materials, adequate data on the composition of
(intermediate) materials must be communicated via the supply chain, up to but not including the retail stage.
For this purpose, a ‘Declaration of Compliance’ (DoC) needs to be provided. The DoC is based on supporting
documentation which documents the reasoning on the safety of a plastic food contact material, and
which must be provided to enforcement Authorities on their request. The supporting documentation also
provides an important link to the manufacturer’s responsibility under GMP (Commission Regulation (EC) No
2023/2006).

Amendment - European Commission Regulation (EU) 2020/1245

The European Commission has published Regulation (EU) 2020/1245 to amend Regulation (EU) No
10/2011 on plastic food contact materials and articles and will enter into force on 23 September 2020. Annex I - Table 1: Union list of
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before 23 September authorised materials
2020, and which were first placed on the market before 23 March 2021, may continue to be placed on the
market until 23 September 2022 and remain on the market until the exhaustion of stocks. 1. Amendments to existing authorised
substances
As with previous amendments, changes to the Union List (also known as the Positive List) of permitted a. Entry 236: 1,3-phenylenediamine-
substances or their restrictions are included within Regulation (EU) 2020/1245. These include amendments Adding a detection limit of 0.002
to the detection or migration limits of existing permitted substances but also some new additions to the list. mg/kg food or food simulant
b. Entry 398: Antimony trioxide-
New Additions to the Positive List – Amendment to Annex I Specific migration limit of 0.04 mg/
New substances added to the positive list include Montmorillonite clay modified with kg food or food simulant and its
hexadecyltrimethylammonium bromide, Phosphorous acid, triphenyl ester, polymer with alpha-hydro omega- note on compliance verification will
hydroxypoly [oxy(methyl1,2-ethanediyl)], C10-16 alkyl ester and titanium dioxide surface-treated with be included in Annex II
fluoride-modified alumina.
2. Additions of authorised substances
Montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) is typically used as an a. Entry 1075: Montmorillonite clay
additive in polylactic acid (PLA) bottles intended for contact with water for long term storage at ambient modified with
temperature or below. The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) hexadecyltrimethylammonium
assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA bromide
which was published in January 2019(4). When incorporated in PLA, nanosized layers of this substance b. Entry 1076: Phosphorous acid,
can be dispersed in the matrix but are not expected to migrate. In addition, the migration of aluminum was triphenyl ester, polymer with
found to be low and the migration of HDTA was detected at the limit of detection. As a result, the CEP Panel alpha-hydro-omega-hydroxypoly
concluded that the substance is not of safety concern for the consumer if the substance is used as an [oxy(methyl-1,2-ethanediyl)], C10-
additive. 16 alkyl ester, CAS No. 12279-37-
46-3- Specific migration limit of
Titanium dioxide surface-treated with fluoride-modified alumina is typically intended to be used as filler 0.05 mg/kg food or food simulant
and colorant up to 25% w/w in potentially all polymer types. Materials and articles containing the additive c. Entry 1077: Titanium dioxide
are intended to be in contact with all food types for any time and temperature conditions. In 2019, surface-treated with fluoride-
EFSA published a safety assessment of this this substance(5) and the panel concluded that the data modified alumina
demonstrated that the substance does not raise safety concern if used as an additive up to 25% w/w in
polymers in contact with all food types for any time and temperature conditions. There were some concerns
where polar polymers with this embedded additive were in contact with foodstuffs simulated by 3% acetic
acid and contact time with the foodstuff should be limited.

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Specific migration limits - Amendments to Annex II

Within Annex II there will be a new table on the migration limits for substances and their salts from plastics materials and articles (Table 1). The
number of substances in Annex 2 has extended from 9 to 19.

Whilst the existing migration limits remain unchanged there are some additional remarks for some limits. The significant ones are:

1. For total chromium, the detection limit of 0.01 mg/kg shall apply. However, if the operator who places the food contact material on the market
can prove that the presence of chromium (VI) is excluded, a limit of 3.6 mg/kg shall apply.
2. For lanthanide substances (europium, gadolinium, lanthanum and terbium),
• The sum of all lanthanide substances migrating to food or food simulant shall not exceed the specific migration limit of 0.05 mg/kg
• There shall be analytical evidence using a well described methodology demonstrating the lanthanide substance(s) used are present in
dissociated ionic form in the food or food simulant. The evidence shall form part of the supporting documentation referred to in Article 16.

Salts allowed in accordance Specific migration limit

with Article 6(3)(a) (mg/kg food or food simulant)
Aluminum Yes 1
Ammonium Yes -
Antimony No 0.04
Arsenic No Not detected
(Limit of detection 0.01)
Barium Yes 1
Cadmium No Not detected
(Limit of detection 0.01)
Calcium Yes -
Chromium No Not detected
[please refer to point c(i)]
Cobalt Yes 0.05
Copper Yes 5
Europium Yes 0.05
[please refer to point c(ii)]
Gadolinium Yes 0.05
[please refer to point c(ii)]
Iron Yes 48
Lanthanum Yes 0.05
[please refer to point c(ii)]
Lead No Not detected
(Limit of detection 0.01)
Lithium Yes 0.6
Magnesium Yes -
Manganese Yes 0.6
Mercury No Not detected
(Limit of detection 0.01)
Nickel No 0.02
Potassium Yes -
Sodium Yes -
Terbium Yes 0.05
[please refer to point c(ii)]
Zinc Yes 5

Table 1 Annex II Amendments - Specific migration limits

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An additional amendment to Annex II concerns the detection limit for primary aromatic amines (PAAs). Primary aromatic amines (‘PAAs’) are
used in plastic food contact materials as colorants or may be present as not intentionally added substances. Some PAA are carcinogens or
suspected carcinogens. As a result, the migration of PAAs into food has been restricted to a specified level that is not detectable in the food
or food simulant by means of commonly used analytical methods.

At present, the restriction on PAAs in Annex II applies to all PAAs that are not listed in Table 1 of Annex I to the Regulation. The PAAs of most
concern are listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council
(6), also referred to as ‘the Azocolourants entry’.

In Appendix II, for the PAAs listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) No 1907/2006, “if no migration limit is
specified in Table 1 of Annex I to Regulation (EU) No 10/2011, they shall not be detectable with a limit of detection of 0.002 mg/kg food or
food simulant applied to each individual PAA”. As these are the PAAs of most concern, the European Commission highlights that it would be
appropriate to apply the new detection limit only to these substances.

Additionally “for PAAs not listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation, if no migration limit is specified in Annex I to
Regulation (EU) No 10/2011, the sum of those PAAs shall not exceed 0.01 mg/kg in food or food simulant.”

Amendment to Annex IV
The information requirements under point 6 of Annex IV will be strengthened to ensure adequate information on the presence of substances
or degradation products which are listed in Annex II should be documented to allow the downstream business operators to ensure compliance
with the Regulation.

The information requirements include identification and quantification on substances in intermediate materials particularly for those that are
subject to restrictions in Annex II or those that may be a suspected genotoxic substance.

Compliance Testing - Amendments to Annex V

Annex V has a significant addition of testing rules that are specific to food processing equipment and appliances. Migration tests should
consider migration from the equipment in its entirety or from a part, as appropriate, under the worst-case use conditions. Testing of parts used
for storage or supply such as reservoirs, containers, capsules, or pads shall be included in the testing under conditions representative of their
use.

There are also amendments concerning repeated use materials and articles. Testing should demonstrate that the specific migration between
subsequent tests does not increase with testing to be carried out three times on a single sample using another portion of food simulant on
each occasion.

In Chapter 3 there is an additional new standard testing condition (OM0) for overall migration. This contact time of 30 mins and contact
temperature for testing 40°C is added for the intended food contact conditions where materials and articles are in contact with food only at
cold or ambient temperatures for 30 minutes or less.

An amendment to the overall migration testing condition OM4, a reflux condition will be available as an option when testing at 100°C is
technically difficult [1 h at 100 °C or at reflux] and there are some additional amendments which correct some of the wording related to overall
migration testing.

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Steps to maintaining compliance

As this Regulation has regular amendments, it is important to be aware of the latest amendment in order to maintain compliance for your
products. Practical steps which you can take towards achieving compliance include:
1. Verify which regulations (in addition to the (EU) 1935/2004) are in place for your products to fulfil compliance in global and/or local
markets. For Europe, monitor the European Commission legislation updates for Food Contact
2. Gather a complete list of all materials and substances used in the production of your food contact material/product. Identify if the
substances of your material may be used (check positive list(s)) and/or if there are any limitations.
3. Identify the food contact application of your material (kind of foodstuff, time and temperature conditions).
4. Conduct robust test programs either in house or via an expert 3rd party laboratory including rigorous migration studies. Set up a
compliance scheme for your product/material. This may include migration tests, worst case calculation/modelling, screening tests, NIAS
studies/toxicological risk assessment.
5. Prove GMP compliance
6. Set up a declaration of compliance and make sure all supporting documentation is available on request. If you do not have a regulatory
function in house, work with an expert to ensure that the DoC is accurate and contains all necessary information.
7. Set up a compliance management and supply chain management system to mitigate the impact of changes in the composition of your
materials, processes or changes in the regulation towards the compliance of your FCM. Ensure there is good communication across the
supply chain.

Conclusion
Regulation (EU) 2020/1245 to amend Regulation (EU) No 10/2011 will enter into force 23 September 2020. It brings with it a raft of
significant amendments including new additions to the Union list and changes to the migration limits or restrictions.

Additions covering processing equipment and repeated use articles are specified which may well have implications for many types of new
substance or products. New testing parameters and consultation with experienced regulatory experts at an early stage can help put in
place suitable programs to address ongoing compliance so you can be ready to meet the requirements of this new amendment.

References
1. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with
food Text with EEA relevance.
2. Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on plastic materials and articles
intended to come into contact with food (Text with EEA relevance.)
3. Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic
materials and articles intended to come into contact with food.
4. Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food
contact materials, EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Volume 17, Issue 1, January 2019
5. Safety assessment of the substance, titanium dioxide surface treated with fluoride modified alumina, for use in food contact
materials, EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Volume 17, Issue 6, June 2019
6. Consolidated text: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Meet the Author

Kathelijn Nafzger, Application Specialist Food Contact for Intertek Polychemlab, Geleen, The Netherlands. Since
2014, Kathelijn has been responsible for the technical and commercial implementation of customer’s food contact
compliance programs in the role of Application Specialist Food Contact for Intertek Polychemlab in Geleen, The
Netherlands. Using her knowledge about food contact regulations, her focus is to support clients with the
compliance program of their products.

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