Food Contact Materials

Mervyn Briggs

Food Standards AgencyNorthern Ireland

Overview on presentation

• Aims of EU legislation• Core EU Framework Regulations • Specific or EU harmonised measures• Enforcement

A Schematic view of EU Food Contact Material Law

http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm

General requirement for all contact materialsRegulation (EC) No. 1935/2004

Good Manufacturing Practice Regulation (EC) No. 2023/2006

Specific measures for 3 groups of materials

OrganicFood Contact Plastics Regulation (EU) 10/2011

FibrousRegenerated cellulose film Directive 2007/42

InorganicCeramicsDirective 84/500 as amended

Controls on individual substances

VCM Directive 78/142Vinyl chloride monomer

Nitrosamines Directive 93/11

Epoxy Derivatives Regulation (EC) 1895/2005

Materials not yet covered by specific directives

• Varnishes and coatings• Paper and board• Metals and alloys• Textile products• Elastomers and rubber• Glass• Wood ( including cork)• Paraffin waxes and• Micro crystalline waxes

General requirements of 1935/2004 apply.

Application of Regulation (EC) No. 1935/2004

The rule applies to materials and articles in their

finished state

• intended to come into contact with food• reasonably expected to come into contact with food

e.g. Inside surfaces of refrigerators and • there is a reasonable expectation of the transfer of

constituents into food e.g. Print inks or adhesive labels

What are Food Contact Materials?

• These are not defined in the regulations but clearly include all elements that make up

• Food Packaging/wrapping• Cookware• Cutlery• Tableware• Work surfaces• Food contact parts of processing machinery

and equipment

Some examples

Some more examples

Main provisions of Regulation (EC) No. 1935/2004

1. General protective requirement (Article 3)

2. Active and intelligent materials and articles (Article 4)

3. Specific measures

4. European Food Safety Authority (EFSA)and Substance authorisations (Article 11)

5. Labelling (Article 15)

6. Compliance declarations ( Article 16)

7. Traceability (Article 17)

General protective requirement of Regulation (EC) No 1935/2004

Food Contact materials including active and intelligent materials and articles ;

• Must be made under good manufacturing practice (GMP)

• Must not transfer constituents in quantities that• will harm human health• cause unacceptable changes to the composition

of food• cause deterioration to organoleptic character of

food• Labelling, advertising etc., must not mislead

consumers

Active and intelligent materials and articles

• Must comply with the EU rules on food (e.g. Food additives)• Must be authorised and according to EU rules on food.• Released substances are treated as ingredients• Must not change the nature or quality of food to mislead

consumers• Properly labelled

• Identify non-edible parts “Do not eat”• Identify material as active or intelligent• Identify nature of released active component• Information on permitted use of active systems

Regulation (EC) No. 450/2009 (Specific measures)

Specific Measures

1. Active and intelligent materials and articles

2. Adhesives

3. Ceramics

4. Cork

5. Rubber

6. Glass

7. Ion-exchange resins

8. Metals and alloys

9. Paper and board

10. Plastics (virgin & recycled)

11. Printing inks

12. RCF

13. Silicones

14. Textiles

15. Varnishes and coatings

16. Waxes

17. Wood

European Food Safety AuthorityProvisions liable to affect public health must be adopted afterconsulting EFSA

Substance authorisation:EFSA will give an opinion within 6 months of an applicationbeing made based on the intended conditions of use of thematerial or article in which it is used. The substance must complywith the safety criteria ( Article 3 and 4).

EFSA web address: http://www.efsa.europa.eu/

Labelling

Materials and articles must be accompanied by

1. “For food contact” or a symbol indicating their use

2. Instructions for safe use.

3. Details of manufacturer, processor or seller responsible for first placing on the market.

4. Traceability information

5. Information of the permitted use of active materials

Compliance declarations

• A written declaration indicating that the material or article complies with EU rules

• Documentation must be available to demonstrate compliance and available to authorities on demand.

• In the absence of specific measures the rules do not prevent Member States from retaining or adopting National provisions for declarations of compliance.

FSA Guidance: Guide to UK legal compliance

and good practice for business documentation June 2009

http://www.food.gov.uk/foodlabelling/foodcontactmaterials2/legalcompliancefoodpackaging

Typical information required in a Declaration of Compliance:

• Name/Address of producer/manufacturer/importer• Material Description/Identification• Date of Declaration• Test Results• Statement of compliance including relevant

Directive/Regulations• Specifications on components/materials.• Information for downstream use• Specification restricting types of food and intended

conditions of use• Statement regarding use of functional barrier

Traceability

• Traceability must be ensured at all stages for the control and

recall of defective products, consumer information and

Attribution of responsibility

• Where feasible businesses must have systems and procedures

to identify businesses they supply and receive from.

• Goods placed on EU market must be identifiable in a way

that allows their traceability by means of labelling/

Documentation/Information.

Good Manufacturing Practice (GMP)

• EC Regulation 2023/2006 (GMP Regulation)• Elaborates on GMP in (1935/2004)• Defines GMP, QA, QC and other key terms• Requires Business operators to

• Establish documented QA and QC procedures relating to compliance and safety of finished products

• Document records of manufacturing• Make available documents to Competent authority

FSA Guidance: Guide to UK legal compliance

and good practice for business documentation June 2009

http://www.food.gov.uk/foodlabelling/foodcontactmaterials2/legalcompliancefoodpackaging

Specific EU measures

• Vinyl Chloride monomer (VCM)

• Plastics

• Active and Intelligent materials and articles

• Ceramics

• Regenerated cellulose film

Regulation (EU) 10/2011

Council Directive 78/ 142

The maximum VCM level in a material or article intended to come into contact with food is

1 mg/kg in the final contact material product

VCM should not be detectable in

Foodstuffs in excess of 0.01 mg/kg.

Vinyl Chloride Monomer (VCM)

Regulation (EU) 10/2011 on plastic materials and articles

intended to come into contact with food

Specific EU Measure on Plastics

Covers plastic materials and articles and their parts

a. Consisting exclusively of plastic orb. Composed of two or more layers of materials each consisting exclusively of plastic, bound together by adhesives or other means.When in the finished product state are intended to comeinto contact with food and are intended for that purpose.

Regulation (EU) 10/2011 Article 2

Plastics Overall Migration Limits(OML)

Outlines the amount of a constituent of plastic contact material that is allowed to migrate out of the contact material. The standard is 10 milligrams per square decimetre of surface area or in the case of materials in contact with infant food not more than 60 milligrams per kilogram released into a food simulant.

Regulation (EU) 10/2011 Article 12

Specific Migration Limit (SML)

Where there is no specific migration limit or restriction in Annex 1 the limit is 60 mg/kg

Regulation (EU) 10/2011 Article 11

BADGE/BFDGE/NOGE in coatings

Regulation (EC) No 1895/2005

• Applicable to plastics, surface coatings and adhesives• BADGE SML 9 mg/Kg• Badge-chlorohydrin adducts SML 1 mg/Kg• BFDGE and NOGE prohibited• Declaration of compliance and supporting documentation required

Recycling Plastics – Regulation EC 282/2008

• Mechanical recycling processes, not chemical ones

• Authorisation for processes required, approval by EFSA

• Community Register• DoC and GMP requirements• EFSA Guideline on submission of dossiers

available

The Plastic Kitchenware (Conditions of Import from China) Regulations (Northern Ireland)

2011

• Primary aromatic amines

• Formaldehyde.• Enforced by

District Councils

Northern Ireland Legislation implementing EU rules

Secondary Legislation • Materials and Articles in Contact with Food Regulations (NI) 2007 SR. No. 434• Materials and Articles in Contact with Food (Amendment) Regulations (NI) 2009 SR. No. 377• Plastic Materials and Articles in Contact with Food Regulations (NI) 2009 SR.No. 56• Ceramic Articles in contact with Food Regulations (NI) 2006 SR. No. 217

Primary legislation• Food Safety (NI) Order 1991

Changes to legislation

• 12 week Consultation started on 20th January 2012.

• Consolidation of the food contact materials legislation

• The Materials and Articles in Contact with Food Regulations (NI) 2012. (Currently being made and proposed coming into operation on 20th November 2012)

Enforcement of legislation

• Food Standards Agency• District Council EHOs

Powers of authorised officers

• Enter premises to determine compliance with the regulations (Includes GMP)

• Inspect records on site e.g. traceability • Inspect GMP and associated records and documents.

(Quality Assurance/Quality Control).• No offence is needed to look at records.• Take samples of materials and articles intended for

use as food contact material.• Submit samples to a Public Analyst for chemical

analysis.

END

Any Questions?