Presentation - Mervyn Briggs - Northern Ireland Polymers Association

Food Contact Materials
Mervyn Briggs
Food Standards Agency
Northern Ireland
Overview on presentation
Aims of EU legislation
Core EU Framework Regulations
Specific or EU harmonised measures
A Schematic view of EU Food
Contact Material Law
General requirement for all
contact materials
Regulation (EC) No. 1935/2004
Good Manufacturing Practice
Regulation (EC) No. 2023/2006
Specific measures for 3 groups of materials
Food Contact
Regulation (EU)
cellulose film
Directive 2007/42
Directive 84/500
as amended
Controls on individual substances
VCM Directive 78/142
Vinyl chloride monomer
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
What are Food Contact
• 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
• 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
• Labelling, advertising etc., must not mislead
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
• 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
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 &
11. Printing inks
12. RCF
13. Silicones
14. Textiles
15. Varnishes and
16. Waxes
17. Wood
European Food Safety Authority
Provisions liable to affect public health must be adopted after
consulting EFSA
Substance authorisation:
EFSA will give an opinion within 6 months of an application
being made based on the intended conditions of use of the
material or article in which it is used. The substance must comply
with the safety criteria ( Article 3 and 4).
EFSA web address:
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
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
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 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/
Good Manufacturing Practice
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
Specific EU measures
• Vinyl Chloride monomer (VCM)
•Active and Intelligent materials and articles
• Regenerated cellulose film
Vinyl Chloride Monomer (VCM)
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.
Regulation (EU) 10/2011
on plastic materials and articles
intended to come into contact
with food
Specific EU Measure on Plastics
Regulation (EU) 10/2011 Article 2
Covers plastic materials and articles and their parts
a. Consisting exclusively of plastic or
b. 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 come
into contact with food and are intended for that
Plastics Overall Migration
Regulation (EU) 10/2011 Article 12
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.
Specific Migration Limit (SML)
Regulation (EU) 10/2011 Article 11
Where there is no specific migration limit or
restriction in Annex 1 the limit is 60 mg/kg
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
• Authorisation for processes required,
approval by EFSA
• Community Register
• DoC and GMP requirements
• EFSA Guideline on submission of dossiers
The Plastic Kitchenware (Conditions of Import
from China) Regulations (Northern Ireland)
• Primary
aromatic amines
• Formaldehyde.
• Enforced by
District Councils
Northern Ireland Legislation
implementing EU rules
Primary legislation
• Food Safety (NI) Order 1991
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
Changes to legislation
• 12 week Consultation started on 20th
January 2012.
• Consolidation of the food contact materials
• 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
Any Questions?

similar documents