Food Contact Materials | Q4 2020

Eurofins newsflash Food Contact Materials

Regulatory news

Europe

Harmonised marking specifications for single-use plastics products

On 18th December 2020, the European Commission published the following regulation related to single-use plastics:

Commission Implementing Regulation (EU) 2020/2151 of 17 December 2020 laying down rules on harmonised marking specifications on single-use plastic products listed in Part D of the Annex to Directive (EU) 2019/904 of the European Parliament and of the Council on the reduction of the impact of certain plastic products on the environment.

Below, a summary table of the harmonised marking specifications:

Harmonised marking specifications (printed marking on the packaging)
Annex I	Sanitary towels (pads) (with the surface area of 10 cm² or more)	Tampons and tampon applicators (with the surface area of 10 cm² or more)

Annex II	Wet wipes (pre-wetted personal care and domestic wipes with the surface area of 10 cm² or more)

Annex III	Tobacco products with filters and filters marketed for use in combination with tobacco products (with the surface area of 10 cm2 or more)

Harmonised marking specifications (printed marking on Beverage cups)
Annex IV	Beverage cups made partly from plastic	Beverage cups made wholly from plastic (printed marking or the following engraved/embossed marking)
		Placed on the market before 4 July 2022 may be affixed by means of stickers.
Note: the printed marking are available in 23 languages of Europe Union in the Official Journal of the European Union.

The Regulation available further information about requirements of position, size, design and others relevant points for marking. It shall apply from 3 July 2021.

Amendment of Regulation (EU) No 10/2011 on food contact plastic materials

On 2^nd September 2020, the 15^th amendment and correction to the Regulation (EU) 10/2011 was published by the European Commission:

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.

The amendment entered into force on 23rd September 2020 with a transition period of two years, until 23 September 2022. For plastic materials and articles that comply with Regulation (EU) No 10/2011 which enter the market before 23 March 2021, they will remain on the market until the exhaustion of stocks.

Following, the published main points in the 15th amendment:

Annex I of Regulation (EU) 10/2011 - Union list of authorized substances

Entry	Replaced in table 1 by
236	23050	0000108-45-2	1,3-phenylenediamine	No	Yes	No	ND	(28)
398	35760	0001309-64-4	antimony trioxide	Yes	No	No		(6)

Entry	New added authorised substances in table 1
1075			Montmorillonite clay modified with hexadecyltrimethylammonium bromide	Yes	No	No		Only to be used as additive at up to 4,0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
1076		1227937-46-3	Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester	Yes	No	No	0,05	Only to be used as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.
1077			Titanium dioxide surface-treated with fluoride-modified alumina	Yes	No	No		Only to be used at up to 25,0 % w/w, including in the nanoform.	29

Note nº	Table 3 – New added notes on verification of compliance
28	A detection limit of 0,002 mg/kg food or food simulant applies
29	In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.’

Annex II of Regulation (EU) 10/2011 - Restrictions on plastic materials and articles

It is entirety replaced. The main points are:

A new table 1 -General list of migration limits for substances migrating from plastic materials and articles. These substances shall only be used in accordance with the compositional requirements set out in Chapter II or may only be present as an impurity subject to the restrictions specified in this Table.
Point 2 - Primary aromatic amines (“PAAs”)

List of PAAs (Entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) No 1907/2006)
If they are listed and no migration limit is specified in Table 1 of Annex I	Detection limit: 0.002 mg/kg food or food simulant applied to each individual PAA
If they are not listed and no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19.	The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

Annex IV of Regulation (EU) 10/2011 - Declaration of compliance

Point

Replaced by

‘Adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,

That are subject to restrictions in Annex II, or
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 a migration from the final material exceeding 0,00015 mg/kg food or food simulant. ’

Annex V of Regulation (EU) 10/2011 - Compliance testing.

CHAPTER 2 Testing for specific migration of materials and articles not yet in contact with food
2.1.3. Conditions of contact when using food simulants	Adds point (iv) on defining rules for the migration of plastic materials or components in food processing equipment or appliance. The main points are: The food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and The migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use. When the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing
2.1.6. Repeated use materials and articles	Entirety replaced section. See the new text in the official publication.
CHAPTER 3 - Testing for overall migration
3.1. Standardised testing conditions	In the Table 3 - Standardised conditions for testing the overall migration the main changes are: Added new test OM0 (30 min at 40 °C) for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes). “or at reflux” has been added to test OM4 In all notes of the table has been added the test OM0
3.2. Substitute overall migration tests for tests with food simulant D2	The paragraphs, before the table of this section,n are replaced. See the new text in the official publication.
3.3. Verification of compliance	The text of the section 3.3.2. Repeated use articles and materials is replaced in its entirety. See the new text in the official publication.

To read the consolidated version of Regulation (EU) nº 10/2011 with the 15th amendment included, click here.

Recent publications by European Commission

The below table summarises recent publications by the Official Journal of the European Union:

Date	Reference	Title
16/10/2020	2020/C 345/40	Amendments adopted by the European Parliament on 24 October 2018 on the proposal for a directive of the European Parliament and of the Council on the reduction of the impact of certain plastic products on the environment (COM(2018)0340 — C8-0218/2018 — 2018/0172(COD))

Standards updates

Please see the below table summarising the most recent standards updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

(**) Date of availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.

CENELEC / CEN
Reference	Title	*Date of Withdrawal ()**	Supersedes
EN 13834:2020	Cookware - Ovenware for use in traditional domestic ovens	2021-03-31	EN 13834:2007+A1:2009
EN ISO 10352:2020	Fibre-reinforced plastics - Moulding compounds and prepregs - Determination of mass per unit area and fibre mass per unit area (ISO 10352:2020)	2021-03-31	EN ISO 10352:2010
EN ISO 21976:2020	Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)	2021-04-30	EN 16679:2014
Reference	Title	Date of Availability ()**	Supersedes
CEN/TS 17497:2020	Pulp, paper and paperboard - Determination of bisphenol A in extracts from paper and paperboard	2020-08-26	CEN/TS 17497:2020

Technical publications

Please find below a table summarising the most recent technical publications (non-exhaustive):

Date	Countries	Entity	Title
23/06/2020	Europe	European Commission	Summary of discussions of the Expert Working Group on Food Contact Materials on the use and placing on the market of plastic food contact materials and articles containing ground bamboo or other similar constituents (updated document following discussion of point A.08 during the PAFF Committee on toxicological safety on 23 June 2020)
01/09/2020	Europe	Organisation for Economic Co-operation and Development (OECD)	PFASs and alternatives in food packaging (paper and paperboard): Report on the commercial availability and current uses
18/09/2020	Germany	German Federal Institute for Risk Assessment (BfR)	Per- and polyfluoroalkyl substances (PFAS): New opinion from the European Food Safety Authority
21/09/2020	Germany	German Federal Institute for Risk Assessment (BfR)	Ceramic dishes: BfR recommends lower release quantities for lead and cadmium (in German)
21/09/2020	Germany	German Federal Institute for Risk Assessment (BfR)	Ceramic crockery: BfR recommends lower release of lead and cadmium (in English)
21/09/2020	Germany	German Federal Institute for Risk Assessment (BfR)	Frequently asked questions about per- and polyfluoroalkyl substances (PFAS)
22/09/2020	Europe	Biodegradable Products Institute (BPI)	Guidelines for the Labeling and Identification of Compostable Products and Packaging
25/09/2020	Europe	Regional Activity Centre for Sustainable Consumption and Production (SCP/RAC)	Plastic’s toxic additives and the circular economy.
14/10/2020	Europe	European Food Safety Authority’s (EFSA)	assessment of the impact of the iarc monograph vol. 121 on the safety of the substance styrene (fcm no 193) for its use in plastic food contact materials

Switzerland

Updated positive list for food contact materials

On 1^st December 2020, the new positive list of substances on materials and objects intended to come into contact with foodstuffs became effective. This list applies to packaging ink and it is under Annex 10 of the DFI ordinance on materials and objects intended to come into contact with foodstuffs of RS 817.023.21 (in French, German or Italian).

The official publication of positive list in Swiss Confederation website (in French, German or Italian).

China

China released GB Standards relevant to Infant, Textiles & Footwear, FCM and other consumer products

Recently, the State Administration for Market Regulation (SAMR) and the Standardization Administration of the People’s Republic of China (SAC) published announcement No.22 of 2020 and announcement No. 23 of 2020 (in Chinese) to approve and release a batch of GB standards, which are closely related to our industries.

The below table listed some of these standards (non-exhaustive list):

Standard No.	Standard Name	Superseded Standard	Implementation Date
Infant Products
GB 38995-2020	Infant feeding bottles and teats	Initial	2021-11-01
FCM
GB/T 18006.3-2020	General requirement of degradable disposable tableware	GB/T 18006.1-2009	2020-12-31
Others
GB/T 39107-2020	Determination of volatile organic compounds content for consumer products—Static headspace sampling method	Initial	2020-10-21
GB/T 39110-2020	Consumer product—Plastics—Rapid screening of phthalates	Initial	2020-10-21
GB/T 39181-2020	Consumer products―Polyester fiber and ABS material―Rapid determination method of fragrance allergens	Initial	2020-10-21
GB/T 39183-2020	Determination of the migration quantity of nitrosamines in consumer products—Gas chromatography-tandem mass spectrometry	Initial	2020-10-21

Standards updates

See below a table summarising some recent ASTM standards updates:

Reference	Title
ASTM C368 - 88(2020)	Standard Test Method for Impact Resistance of Ceramic Tableware
ASTM C614 - 20	Standard Test Method for Alkali Resistance of Porcelain Enamels
ASTM C285 - 10(2020)	Standard Test Methods for Sieve Analysis of Wet-Milled and Dry-Milled Porcelain Enamel
ASTM C660 - 81(2020)	Standard Practices for Production and Preparation of Gray Iron Castings for Porcelain Enameling
ASTM C664 - 10(2020)	Standard Test Methods for Thickness of Diffusion Coating
ASTM C1466 - 00(2020)	Standard Test Method for Graphite Furnace Atomic Absorption Spectrometric Determination of Lead and Cadmium Extracted From Ceramic Foodware
ASTM C738 - 94(2020)	Standard Test Method for Lead and Cadmium Extracted from Glazed Ceramic Surfaces

Other relevant news

Date	State/country	News
02/12/2020	New York	The Governor signed the Bill nº S8817 (same as A04739-C) which prohibited on the use of perfluoroalkyl and polyfluoroalkyl substances in food packaging.
24/09/2020	New Jersey	New Jersey published the bill nº 864 concerning the ban of following products of single-use: plastic and paper carryout bags, polystyrene foam food service products, and plastic straws.
24/09/2020	California	Bill No. 793 was approved which requires every beverage container sold or offered for sale in this state to have a minimum refund value. The act requires each glass container manufacturer to use a minimum percentage of 35% of post filled glass in the manufacturing of its glass food, drink, or beverage containers, except as specified.
29/09/2020	California	Bill No. 2287 has been published which prohibits a person from selling a plastic product that is labelled with the term “compostable,” “home compostable,” or “marine degradable” unless, at the time of sale, the plastic product meets the applicable ASTM standard specification or the Vincotte OK Compost HOME certification.
07/10/2020	Canada	Canada one-step closer to zero plastic waste by 2030
20/10/2020	US	New substances added to FDA inventory of Effective Food Contact Substances here.