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Food Contact Materials | Summer Recap 2020

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Eurofins newsflash Food Contact Materials

 

Regulatory news

 


 

Denmark

 

Ban on PFAS in cardboard and paper food contact materials

 

On 25th 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:

 

The full list of BfR recommendations can be found here.

 

Ban single-use plastic products

 

On 24th 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 11th 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 25th 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:

 

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.

 

US

 

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:

 

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

 

 

China

 

National Supervision and Spot Check Plan 2020

 

On 8th 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 20th 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:

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 16th April 2020 to 20th 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 21st May 2020 to 30th 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