Food Contact Materials | Summer Recap 2020

Eurofins newsflash Food Contact Materials

Regulatory news

Denmark

Ban on PFAS in cardboard and paper food contact materials

On 25^th May 2020, the Ministry of Environment and Food of Denmark has published an updated version of the national legislation on food contact materials – Order no. 681.

The new regulation introduces a ban on the use of all per- and polyfluorinated substances (PFAS) in cardboard and paper food contact materials. The regulation permits the presence of fluorinated substances, for example from inks or recycled paper and paper, but only if they are used behind a functional barrier, which ensures that the substances do not migrate to the food.

The Executive Order replaces current No. 1248 of October 30, 2018 and comes into force on July 1, 2020.

The following points have been added:

Insertion of definition for paper and cardboard in §2 (3)
Inserting a ban on the use of per- and polyfluorinated substances in food contact materials of cardboard and paper, unless a functional barrier is used to prevent migration to the food in §8
Insertion of transitional provision for food contact materials of cardboard and paper in § 25 (2). 3
In addition, linguistic and legislative clarifications have been made without substantive meaning

The updated legislation (in Danish) can be found here.

Germany

Update of BfR recommendations on Food Contact Materials

The German Federal Institute for Risk Assessment (BfR) has updated many of their recommendations on food contact materials (FCMs) in the BfR Database.

The latest updates include:

Recommendation XXXVI: Paper and Board for Food Contact (new migration limits for slimicides and aluminum as well as the addition of permitted slimicides, preservatives, and refining and coating agents)
Recommendations XXXVI/1: Cooking Paper, Hot Filter Papers, and Filter Layers
Recommendations XXXVI/2: Paper and Paperboard for Baking Purposes (new restrictions on migration of aluminum to food and increasing the number of permitted substances categorised as antimicrobial agents and preservatives, among others)
Recommendation VII: Polypropylene (catalyst residues)
Recommendation III: Polyethylene (catalyst residues)
Recommendation XIV: Polymer dispersions (expanding the list of monomers that can be used)

Other published articles related to food contact materials:

FAQs about aluminium in food and products intended for consumers

The full list of BfR recommendations can be found here.

Ban single-use plastic products

On 24^th June 2020, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety launched the government draft of the regulation to ban single-use plastic products.

The Einwegkunststoffverbotsverordnung (EWKVerbotsV) is the first step to transpose the European Directive 2019/904/EU into national law. The German Bundestag and Bundesrat have to decide on the regulation in autumn 2020.

Due to Article 17 European Directive 2019/904/EU, the German EWKVerbotsV will enter into force on 3 July 2021.

For further information concerning the EWKVerbotsV please visit bmu website here.

For getting the official news, please click here.

France

New decree for rubber and pacifiers

On 11^th August 2020, the France authorities published the following decree:

Order of 5 August 2020 relating to rubber materials and objects intended to come into contact with foodstuffs and pacifiers for infants and young children

This decree apply rubber materials and articles intended to come into contact with foodstuffs and pacifiers for infants and young children. It replaces and repeals the decree of November 9, 1994.

The main points are:

It updates the lists of authorized constituents.
It clarifies and updates certain rules for verifying the conformity of rubber materials and articles.
It provides a model for the declaration of conformity provided for by article 6 of decree n ° 2007-766 of May 10, 2007.

The provisions of this decree come into force on July 1, 2021.

Europe

Call for evidence on broad PFAS restriction

Five European countries (Germany, the Netherlands, Norway, Sweden and Denmark) have launched national calls for evidence in order to compile information about the use of per- and polyfluoroalkyl substances (PFAS) by 31 July 2020.

The aim of this call for evidence is to prepare a joint REACH restriction proposal to limit risks to the environment and human health arising from the manufacture and use of a wide range of PFAS.

Below you can find the national calls as well as the ECHA publication:

Technical publications

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

Date	Entity	Title
April 2020	The British Plastics Federation (BPF) The Cosmetic, Toiletry and Perfumery Association (CTPA) The Food and Drink Federation (FDF)	Industry publishes following new guidelines: Recycled Content Used In Plastic Packaging Applications
April 2020	European Commission	Public Consultation in the context of a Fitness Check of the EU legislation with regard to Endocrine Disruptors: Factual Summary Report
April 2020	EFSA ( European Food Safety Authority)	Assessment of new information on Bisphenol S (BPS) submitted in response to the Decision 1 under REACH Regulation (EC) No 1907/2006
May 2020	EFSA ( European Food Safety Authority)	Safety assessment of the process Veolia URRC used to recycle post‐consumer PET into food contact materials
May 2020	EFSA ( European Food Safety Authority)	Safety assessment of the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate, for use in food contact materials
18/06/2020	Plastic Recyclers Europe	Flexible Films Market in Europe State of Play. Production, Collection and Recycling Data. Eunomia 2020
19/05/2020	United Nations Environment Programme	“Can I Recycle This? A Global Mapping and Assessment of Standards, Labels and Claims on Plastic Packaging.”
10/06/2020	European Food Safety Authority	review and priority setting for substances that are listed without a specific migration limit in table 1 of annex 1 of regulation 10/2011 on plastic materials and articles intended to come into contact with food
11/06/2020	European Commission	EC roadmap: Reducing packaging waste – review of rules
09-06-2020	ANSES (French Agency for Food, Environmental and Occupational Health & Safety)	Nanomaterials in food: ANSES's recommendations for improving their identification and better assessing consumer health risks
10-06-2020	EFSA ( European Food Safety Authority)	Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food
02-07-2020	European Commission	Evaluation of Food Contact Materials (FCMs)
20-07-2020	European Commission	Roadmap: Environmental performance of products & businesses – substantiating claims
21-07-2020	European Council	A new tax will be applied in the EU beginning January 1, 2021 on non-recycled plastic packaging waste at a rate of €0.80 per kilogram
23-07-2020	European Commission	Global Summit on Regulatory Science 2019 Nanotechnology and Nanoplastics
30-07-2020	GOV.UK	Circular Economy Package policy statement
07-08-2020	EFSA (European Food Safety Authority)	Public consultation on the draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles

New update of Candidate List of Substances of Very High Concern (SVHCs)

On 25^th June 2020, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of 4 new substances, the current list of SVHCs contains 209 substances.

Below a table outlines the recent substances included:

Nº	Substance name	EC number	CAS number	Reason for inclusion
1	1-vinylimidazole	214-012-0	1072-63-5	Toxic for reproduction (Article 57 (c))
2	2-methylimidazole	211-765-7	693-98-1	Toxic for reproduction (Article 57 (c))
3	Dibutylbis(pentane-2,4-dionato-O,O')tin	245-152-0	22673-19-4	Toxic for reproduction (Article 57 (c))
4	Butyl 4-hydroxybenzoate (Butylparaben)	202-318-7	94-26-8	Endocrine disrupting properties - human health (Article 57(f) – human health)

Click here for further information on the ECHA’s website.

Regulatory updates

Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):

Countries	Notification number	Title
Hungary	2020/313/HU	*Government Decree on the restriction of the placing on the market of certain single-use plastic products and of certain other plastic products* As of 1 January 2021, this draft prohibits placing on the market products made from oxo-degradable plastic, and the following single-use plastic products and of versions made of biodegradable plastic: 1. Cotton bud sticks 2. Cutlery (forks, knives, spoons, chopsticks) 3. Plates 4. Straws 5. Beverage stirrers 6. Sticks to be attached to and to support balloons, except for industrial or other professional uses and applications that are not distributed to consumers, including the mechanisms of such sticks 7. Food containers made of expanded polystyrene, i.e. receptacles such as boxes, with or without a cover 8. Beverage containers made of expanded polystyrene, including their caps and lids 9. Cups for beverages made of expanded polystyrene, including their covers and lids It also prohibits the placing on the market of the following single-use plastic products and their versions made of biodegradable plastic: - single-use plastic cups for beverages other than those made of expanded polystyrene, including their caps and lids - lightweight plastic carrier bags
Italy	2020/340/I	Pursuant to Article 184b, paragraph 2 of Legislative Decree No 152 of 3 April 2006 The draft regulation identifies the criteria under which paper and cardboard waste, following specific processing and provided that it meets the requirements established in the regulation, cease to be classified as waste such as to be reintroduced into the economic cycle as products
France	2020/401/F	Decree on the prohibition of certain single-use plastic products
France	2020/410/F	Decree on consumer information symbols indicating the sorting rule for waste resulting from products subject to the principle of extended producer responsibility
Hungary	2020/423/HU	Government Decree on the restriction of the placing on the market of certain single-use plastic products and of certain other plastic products
Hungary	2020/445/HU	Act prohibiting the placing on the market of certain single-use plastics
Germany	2020/510/D	Twenty-second Ordinance amending the Consumer Goods Ordinance

New webpage on endocrine disrupting chemicals

In June 2020, national authorities in Belgium, Denmark, France, the Netherlands and Sweden launched a webpage on endocrine disrupting chemicals. The aim of this website is to compile information about these substances and report on their current status in Europe.

For further information , please visit the Endocrine Disruptor Lists website here.

Proposition 65: new fact sheets

See below a list of new fact sheets available in the Proposition 65 website.

Three new fact sheets on Proposition 65-listed chemicals have been added:

Pentabromodiphenyl Ether (PentaBDE) Mixture [DE-71 (Technical Grade)]
Tris(2-chloroethyl) Phosphate (TCEP)
Household appliances may expose you to chemicals on the Proposition 65 list such as benzene, carbon monoxide, formaldehyde, and some flame retardants and phthalates.

Two new fact sheets on Proposition 65 warnings:

New substances added to FDA inventory of Effective Food Contact Substances

The following substances have been recently added to the U.S. Food and Drug Administration’s (FDA) inventory of effective food contact substances (fcs) notifications.

FCN number	Substances	Date
2045	2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, cyclohexyl 2-methyl-2-propenoate, methyl 2-methyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate, 1,2-propanediol mono(2-methyl-2-propenoate) and 2-propen-1-yl 2-methyl-2-propenoate (CAS Reg. No. 1874228-60-0)	April 28, 2020
2043	Cellulose acetate (CAS Reg. No. 9004-35-7), and optionally modified with propionate to form cellulose acetate propanoate (CAS Reg. No. 9004-39-1) resulting in up to 49 weight-percent propionate esters	April 14, 2020
2038	Benzenesulfonic acid, 2-[2-(2,4-diamino-1,6-dihydro-6-oxo-5-pyrimidinyl)diazenyl]-5-methyl- (CAS Reg No. 1021701-36-9).	April 9, 2020
2037	Oleic acid, mono ester with oxybis(propanediol) (also known as diglyceryl monooleate) (CAS Reg. No. 49553-76-6)	April 4, 2020
2036	An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). REPLACES FCN 1639	April 2, 2020
2034	Copolymers of styrene (CAS Reg. No. 100-42-5), α-methylstyrene (CAS Reg. No. 98-83-9), butyl methacrylate (CAS Reg. No. 97-88-1), 2-ethylhexyl acrylate (CAS Reg. No. 103-11-7), methyl methacrylate (CAS Reg. No. 80-62-6), butyl acrylate (CAS Reg. No. 141-32-2), itaconic acid (CAS Reg. No. 97-65-4), methacrylic acid (CAS Reg. No. 79-41-4), hydroxypropyl acrylate (CAS Reg. No. 999-61-1 and CAS Reg. No. 2918-23-2), sodium methallyl sulfonate (CAS Reg. No. 1561-92-8), and sodium styrene sulfonate (CAS Reg. No. 2695-37-6).	March 31, 2020
2033	An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally dipicolinic acid (DPA) (CAS Reg. No. 499-83-2) and/or sodium hydroxide (NaOH) (CAS Reg. No. 1310-73-2). REPLACES FCN 1426	March 31, 2020
2031	Zinc pyrithione (CAS Reg. No. 13463-41-7).	February 25, 2020
2028	Polyurethane resins (CAS Reg. No. 89097-02-9) derived from the reaction of diphenylmethane diisocyanate with 1,3-propanediol and polytetramethylene ether glycol.	February 12, 2020
2026	Blocked isophorone diisocyanate (IPDI) polymer consisting of trimer, pentamer, heptamer, and nonamer oligomers, with the primary component of interest being the trimer (CAS Reg. No. 103170-26-9). REPLACES FCN 1039	March 25, 2020
2025	Cellulose, triacetate (CAS Reg. No. 9012-09-3)	January 31, 2020
2024	Acetic acid ethenyl ester, polymer with ethene and ethenol (CAS Reg. No. 26221-27-2)	January 28, 2020
2023	A mixture of 35-60 percent hydroxysulfinoacetic acid, disodium salt (CAS Reg. No. 223106-41-0), 10-60 percent hydroxysulfoacetic acid, disodium salt (CAS Reg. No. 29736-24-1), and 0-40 percent sodium sulfite (CAS Reg. No. 7757-83-7)	January 22, 2020
2022	Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4)	January 14, 2020
2021	Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4)	January 9, 2020
2020	Mixed esters of C5-C12 fatty acids with pentaerythritol, dipentaerythritol, and polypentaerythritol	January 3, 2020
2019	Platinum 5,10,15,20-tetrakis(pentafluorophenyl)porphyrin (CAS Reg. No. 109781-47-7)	January 2, 2020
2017	Bis(hydrogenated palm-oil alkyl)hydroxy amines (CAS Reg. No. 1374859-51-4)	March 7, 2020

TPCH Proposes to Updates Its Model Legislation for Packaging

Recently, the Toxics in Packaging Clearinghouse (TPCH) proposed to update their Toxics in Packaging Model Legislation, mainly including the addition of PFAS and phthalates as regulated chemicals.

The current Model legislation was developed in 1989 and has been enacted in 19 states to provide consist legislation to reduce heavy metals in packaging and packaging components. Now organization’s draft covers following major changes:

ortho-pthalates may not be present exceed 100 ppm in any package or packaging components;
PFAS may not be present above the detection limit in any package or packaging components;
Removes some of the current exemptions such as vitrified labels and recycled materials.

Comments must be submitted to info@toxicsinpackaging.org by August 24, 2020.

For more information please click here.

Other relevant news this summer

Official definition of “microplastics” in drinking water
New York Senate and Assembly passed bills that ban the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in food packaging. (S8817/A4739C)
FDA Announces the Voluntary Phase-Out by Industry of Certain PFAS Used in Food Packaging
Comment Submissions - Notice Of Proposed Rulemaking Adoption to Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods.

China

National Supervision and Spot Check Plan 2020

On 8^th May 2020, the China State Administration for Market Regulation (SAMR) published the National Product Quality Supervision and Sampling Plan for 2020.

The spot check plan covers a total of 131 products; from household textiles, to electrical and electronic products, light industrial products, construction and decoration materials, agricultural products , mechanical security products, electrical products and materials and food-related products.

For more information, please visit the SAMR website here.

Japan

Positive List for Food-Contact Resins review

On 20^th July 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft Lists of Existing Substances with proposed revisions to Appended Table 1 of MHLW Notification No. 370, the Positive List (PL) of substances used in synthetic resins for utensils, containers and packaging (UCP).

For more information, please consult the MHLW’s website here.

International

Regulatory proposals notified to WTO

Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number	Countries	Title
G/TBT/N/CHN/1406	China	National Standard of the P.R.C., Beer bottles This standard specifies the terms and definitions, product classification, requirements, test methods, inspection rules, marks, packaging, transportation and storage of glass beer bottles. This standard is applicable to glass bottles containing beer
G/TBT/N/KOR/899	Korea	*Amendments to the notification of waste items with limited imports to promote domestic waste recycling* Notification aims to ban the import of waste plastic (PET/PE/PP/PS) and to promote domestic waste recycling. The intention is to limit the import of waste plastics of some materials in order to promote the recycling of waste plastics in Korea
G/TBT/N/EU/731	Europe	Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and related substances
G/TBT/N/ARG/401	MERCOSUR	Draft Common Market Group (GMC) Resolution No. 02/20 "MERCOSUR Technical Regulation establishing general provisions for plastic packaging and equipment that come into contact with food (Amendment to GMC Resolution No. 56/92)
G/TBT/N/ARG/402	MERCOSUR	Draft Common Market Group (GMC) Resolution No.03/20 "MERCOSUR Technical Regulation on the positive list of monomers, other starting substances and polymers authorized for the manufacture of plastic packaging and equipment that come into contact with food (Amendment to GMC Resolution No. 02/12)

Regulatory updates

Please see below a table summarising some recent updates to international legislation and proposals (non-exhaustive):

Date	Country	Update
29/05/2020	South Korea	The Korean Ministry of Food and Drug Safety published the following notification: “Notification of standards and specifications for packaging equipment and containers (Notification No. 2020-43).” The main changes include: Changes to general production standard (raw materials, processing and manufacturing, and reuse) Revisions to migration requirements A new requirement limiting total volatilisation of rubber nipples to 0.5% Revisions to the testing methods for arsenic (CAS 7440-38-2), 1-hexene (CAS 592-41-6), and 1-octene (CAS 111-66-0) Allowing use of recycled polyethylene terephthalate (PET) and polyethylene naphthalate (PEN) in food contact materials Allowing use of chemically recycled resins, but only if used in so that they do not come into direct contact with food
April 2020	japan	Japan Ministry of Health, Labor and Welfare (MHLW) published the following notifications: Notification No. 196 of 2020 ‘Partial revision of the standards for foods, additives etc.’ (plastics, Table 1 (1); coatings, Table 1 (2); Monomers Table 1(3); Additives, coatings etc. Table 2) Notification No. 195 of 2020 ‘Amount specified by the MHLW as an amount that does not harm human health under paragraph 3 in Article 18 of the Food Sanitation Act’
28/05/2020	Brazil	Brazilian National Health Surveillance Agency (ANVISA) published the following resolution to push back the effective date to June 3, 2021 Resolution of the Collegiate Board of Directors No. 391 of May 26, 2020
21/05/2020	Ukraine	Ukrainian Ministry of Economic Development, Trade and Agriculture published the following draft: Draft Law of Ukraine "On Requirements for Materials and Items in Contact with Foodstuffs"
07-08-2020	Australia	Categorisation of chemicals with an end use in articles with food contact

Product Recalls / Alerts

Below you will find a monthly summary table of product recalls and alerts in Europe (Source “RASFF”) and in the US (Source “CPSC”).

Europe

RASFF (European Commission Rapid Alert System for Food and Feed - Alerts reported by EU national authorities).

The following 13 alerts regarding Food Contact Materials were reported from the 16^th April 2020 to 20^th May 2020.

Product	Substance / Hazard
Bamboo fibre decorated cups	Migration of formaldehyde and of melamine	Details
Set of bamboo fiber dishes	Migration of formaldehyde and of melamine	Details
Coffee mugs	Migration of formaldehyde and of melamine, insufficient labelling	Details
Nylon potato masher	Migration of primary aromatic amines	Details
Nylon ladles	Migration of primary aromatic amines	Details
Nylon whisk	Migration of primary aromatic amines	Details
Melamine tumbler	Migration of melamine	Details
Tableware set	Migration of melamine	Details
Rice straws	Unauthorised colours - Gardenia Yellow (presence) and Gardenia Blue (presence)	Details
Plastic plates	Migration of melamine	Details
Tableware	Unauthorised placing on the market of tableware made from a mix of bamboo fibres, melamine and maize starch	Details
Melamine plates	Migration of melamine	Details
Bamboo cutlery	Migration of formaldehyde and melamine	Details

The following 19 alerts regarding Food Contact Materials were reported from the 21^st May 2020 to 30^th June 2020.

Product	Substance / Hazard
Melamine tableware	Migration of formaldehyde (13.8; 19.5; 18.2 mg/kg - ppm)	Details
Table knives	Corrosion (presence of rust)	Details
Nylon serving spoons	Migration of primary aromatic amines (0.1044 mg/kg - ppm)	Details
The consumption of drinks cooled with plastic ice cubes	Suffocation risk	Details
Dessert plates	Migration of lead (>3 mg/kg - ppm)	Details
Plastic bowls	Migration of melamine (7.1 mg/kg - ppm)	Details
Aluminium grill trays	Migration of aluminium (85 mg/kg - ppm)	Details
Plate	Migration of melamine (3.49; 3.95; 2.5 mg/kg - ppm) from	Details
Melamine plates	Migration of melamine (6.07 mg/kg - ppm)	Details
Slotted spoons	Migration of primary aromatic amines (0.045; 0.044 mg/kg - ppm)	Details
Self-heating Taiwan braised pork and rice	Improper packaging (leaking under pressure)	Details
Carbonated caffeinated cola-flavoured drinks	Risk of breakage and explosion of bottles	Details
Sieve spoons	Migration of primary aromatic amines (>0.64 mg/kg - ppm)	Details
Tableware made from a mix of bamboo fibres, melamine and maize starch	Attempt to illegally import from China	Details
Tableware made from a mix of bamboo fibres, melamine and maize starch	Attempt to illegally import from China	Details
Baby sensor spoons	Migration of bisphenol A (124.2 µg/l)	Details
Folding chopping boards	Migration of primary aromatic amines (0.03 mg/kg - ppm)	Details
Slotted spoon	Migration of primary aromatic amines ( 0.0755 mg/kg - ppm)	Details
Nylon spoons	Migration of primary aromatic amines (0.4737 mg/kg - ppm)	Details