Legal requirements for contact materials

Legal requirements for contact materials
Roberto Massini
EHEDG World Congress on Hygienic Engineering& Design 2014 - Italy
© 2014 EHEDG / Roberto Massini
Legal requirementsfor contact materials

Contents
European legislation
Supplementary Italian legislation
US Federal legislation
Conclusions

European legislation

Communitary and National rules
Communitary rules Tecnical rules to be applied
in absence of Communitary
specific rules
Reg. (EC) No 1935/2004
(Framework Regulation)
European measures on
specific substances
European measures on
specific materials
National measures
on specific materials
Requisiti di legge per i materiali a contatto

Framework Regulation (EC) No 1935/2004
It sets:
General principles
Groups of food contact materials and articles
Procedure for authorisation
Contact materials:
Ø Must not transfer their components into food in quantities that could
endanger human health, change food composition in an unacceptable way
or deteriorate its taste and odour.
Ø Are manufactured according to good manufacturing practice .
Ø Are traceable throughout the production chain.
Application for authorisation of a new substance shall be submitted to the
competent authority of a Member State, which, in turn, transmits it to EFSA.
The Authority shall give an opinion as to whether, under the intended conditions
of use of the material or article, the substance complies with the safety criteria.

continued: Regulation (EC) No 1935/2004
Article 16 - Declaration of compliance
1. The specific measures referred to in Article 5 shall require that materials
and articles covered by those measures be accompanied by a written
declaration stating that they comply with the rules applicable to them.
Appropriate documentation shall be available to demonstrate such
compliance. That documentation shall be made available to the competent
authorities on demand.

continued: Regulation (EC) No 1935/2004
Article 17 Traceability
1. The traceability of materials and articles shall be ensured at all stages in
order to facilitate control, the recall of defective products, consumer
information and the attribution of responsibility.
2. With due regard to technological feasibility, business operators shall have
in place systems and procedures to allow identification of the businesses
from which and to which materials or articles [ ] are supplied.
3. The materials and articles which are placed on the market in the
Community shall be identifiable by an appropriate system which allows
their traceability by means of labelling or relevant documentation or
information.

Relevant European harmonized rules
Reg. (EC)No 1935/2004
(framework regulation)
Reg. (EC) No 2023/2006
(GMP)
Reg. (EC) No 282/2008
(recycled plastics)
Plastics (excluding
rubber & silicones)
Ceramics Elastomers
Dir. 84/500/EEC
Dir. 2005/31/EC
Dir. 93/11/EEC
(nitrosamines) just for
teats and soothers
Dir. 93/11/EEC
(nitrosamines) just for
teats and soothers
Reg. (EU) No 10/2011
(repeal Dir. 2002/72/EC)

Regulation (EC) No 10/2011 on plastic materials
and articles intended to come in contact with food
Article 5 Union List of authorized substances
1. Only the substances included in the Union list of authorised substances
(hereinafter referred to as the Union list) set out in Annex I may be
intentionally used in the manufacture of plastic layers in plastic materials
and articles.
Article 11 Specific migration limits
1. Plastic materials and articles shall not transfer their constituents to foods
in quantities exceeding the specific migration limits(SML) set out in Annex
I. Those specific migration limits (SML) are expressed in mg of substance
per kg of food (mg/kg).
Article 12 Overall Migration limit
1. Plastic materials and articles shall not transfer their constituents to food
simulants in quantities exceeding 10 milligrams of total constituents
released per dm2 of food contact surface (mg/dm2).

continued: Regulation (EU) No 10/2011
Article 15 Declaration of compliance
1. At the marketing stages other than at the retail stage, a written declaration in
accordance with Article 16 of Regulation (EC) No 1935/2004 shall be
available for plastic materials and articles, products from intermediate stages
of their manufacturing as well as for the substances intended for the
manufacturing of those materials and articles.
2. The written declaration referred to in paragraph 1 shall be issued by the
business operator and shall contain the information laid down in Annex IV.
3. The written declaration shall permit an easy identification of the materials,
articles or products from intermediate stages of manufacture or substances
for which it is issued. It shall be renewed when substantial changes in the
composition or production occur that bring about changes in the migration
from the materials or articles or when new scientific data becomes available.

ANNEX IV - Declaration of compliance
The written declaration [ ] shall contain the following information:
1) the identity and address of the business operator issuing the declaration [ ];
2) the identity and address of the business operator which manufactures or
imports [ ];
3) the identity of the materials, the articles, products from intermediate stages of
manufacture [ ];
4) the date of the declaration;
5) confirmation that the plastic materials or articles, [ ] meet relevant
requirements laid down in this Regulation and Regulation (EC) No 1935/2004;
6) adequate information relative to the substances used or products of
degradation thereof for which restrictions and/or specifications are set out in
Annexes I and II to this Regulation to allow the downstream business
operators to ensure compliance with those restrictions;

7) adequate information relative to the substances which are subject to a
restriction in food, [ ] to enable the user of these materials or articles to
comply with the relevant EU provisions or, in their absence, with national
provisions applicable to food;
8) specifications on the use of the material or article, such as:
(i) type or types of food with which it is intended to be put in contact;
(ii) time and temperature of treatment and storage in contact with the food;
(iii) ratio of food contact surface area to volume used to establish the
compliance of the material or article;
9) when a functional barrier is used in a multi-layer material or article, the
confirmation that the material or article complies with the requirements of
Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.
continued: ANNEX IV - Declaration of compliance

Union Guidance on Regulation (EU) No 10/2011 on plastic materials and
articles intended to come into contact with food as regards information in
the supply chain. SANCO, Bruxelles, 28.11.2013
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/guidance
_reg-10-2011_without_boxes_en.pdf
Union Guidelines on Regulation (EU) No 10/2011 on plastic materials
and articles intended to come into contact with food. SANCO, Bruxelles,
21.02.2014
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/10-
2011_plastic_guidance_en.pdf
EU Guidances

Technical rules of individual European States
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm

Principle of mutual recognition
Establishes the principle of mutual recognition to products that are not
subject to the harmonized EU legislation, or to aspects of products that fall
outside the scope of this legislation.
Prohibits any national measure capable of hindering, directly or indirectly,
actually or potentially, intra-Community trade of goods.
So food contact national regulations (non-harmonized) must be recognized
as equivalent even if they are not identical!
Regulation (EC) No 764/2008

Supplementary Italian tecnical rules

Italian technical rules
Are regulated, in particular, the following materials:
stainless steels
elastomers

MD 21 March 1973 (as subsequently amended)
It applies to all equipment, plant, tools, objects ...
Positive lists of authorized substances and materials
Each new substance must be authorized by the Ministry of Health, on the
basis of a favorable opinion of the Istituto Superiore di Sanità
Overall Migration limit (8 mg/ dm2 o 50 mg/kgproduct) and, possibly,
Specific migration limits
to be checked, using one or more liquids simulants representative of the
foods with which the contact is provided, in the most unfavorable
conditions of use
barrier concept in the case of multilayer materials
Declaration of compliance, compulsory for each lot
Users of the material should always have available the compliance
declaration and should check the compliance of the material with the legal
and technical requirements
Principles

Art. 36. The objects [ ] can be prepared only with the types of stainless steels
listed in Section 6 of Annex II
Art. 37. The suitability of the objects to come in contact with food must be
determined [...] in the manner specified in section 1 and 2 of Annex IV:
In the case of repeated use, the determination of the specific migration is
performed with three "attacks" after the same duration on the liquid coming
from the third 'attack'.
In case of contact with any type of food, [...] the following tests :
for prolonged contact at room temperature: aqueous solution of acetic acid
at 3 per cent, for 10 days at 40 °C;
for repeated use, of short duration hot or at room temperature: aqueous
solution of acetic acid at 3 percent, at 100 °C for 30 minutes;
Specific migration limits: Cr3+ 0,1 ppm; Ni 0,1 ppm; Mn 0,1 ppm.
continued: MD 21 Marzo 1973
Chapter VI - Objects of stainless steel
(D 21.12.2010 n. 258)

US Federal legislation

The component of an equipment, intended for contact with food and containing
one or more substances that can migrate in the food, is subject to federal
regulations on food additives.
Food equipment
Food-contact article
Food-contact substance
Indirect food additive
Food additive
Regulatory status of components of food
contact materials in the US

Federal Food, Drug, and Cosmetic Act (FD&C Act)
FD&C Act Sec. 201 [21 USC 321] Definitions
(s) The term "food additive" means any substance the intended use of which
results or may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of any food
[ ]), if such substance is not generally recognized, [ ] to be safe under the
conditions of its intended use [ ]
FD&C Act Sec. 409 [21 USC 348] Unsafe Food Additives
(h) Notification Relating to a Food Contact Substance
(1) [ ], a manufacturer or supplier of a food contact substance may, at least
120 days prior to the introduction or delivery for introduction into interstate
commerce of the food contact substance, notify the Secretary (of Health and
Human Services) of the identity and intended use of the food contact
substance, and of the determination [ ] that the intended use of such food
contact substance is safe [ ].

Continued: Code of Federal Regulation Title 21 (21 CFR)
21 CFR 170.3 Definitions
(e) (2) Uses of food additives not requiring a listing regulation. Use of a
substance in a food contact article (e.g., food-packaging or food-processing
equipment) whereby the substance migrates, or may reasonably be expected
to migrate, into food at such levels that the use has been exempted from
regulation as a food additive under 170.39, and food contact substances used
in accordance with a notification submitted under section 409(h) of the act that
is effective.
(3) A food contact substance is any substance that is intended for use as a
component of materials used in manufacturing, packing, packaging,
transporting, or holding food if such use is not intended to have any technical
effect in such food.

continued: Code of Federal Regulation Title 21 (21 CFR)
21 CFR 174 Indirect food additives
Substances used in food-contact articles (e.g., food-packaging or food-
processing equipment) that migrate, or that may be expected to migrate, into
food at negligible levels may be reviewed under 170.39 of this chapter. The
Food and Drug Administration will exempt substances whose uses it
determines meet the criteria in 170.39 [ ] and, therefore, a food additive
petition will not be required for the exempted use.
21 CFR 170.39 Threshold of regulation for substances
used in food-contact articles
(a) Substance used in a food-contact article (e.g., food-packaging or food-
processing equipment) that migrates, or that may be expected to migrate,
into food will be exempted from regulation as a food additive because it
becomes a component of food at levels that are below the threshold of
regulation if:
(1) The substance has not been shown to be a carcinogen in humans or
animals, [ ]

continued: 21 CFR 170.39
(2) The substance presents no other health or safety concerns because:
(i) [ ]
(ii)The substance is currently regulated for direct addition into food, [ ]
(3) The substance has no technical effect in or on the food to which it migrates;
(4) The substance use has no significant adverse impact on the environment.
(b) [ ], the FDA reserves the right to decline to grant an exemption [ ]
(c) A request for the FDA to exempt a use of a substance from regulation as a
food additive shall include three copies of the following information [ ]
(1) The chemical composition of the substance for which the request is made [ ]
(2) Detailed information on the conditions of use of the substance (e.g.,
temperature, type of food with which the substance will come into contact, the
duration of the contact, [ ]
(i) Validated migration data obtained under worst-case (time/temperature)
intended use conditions utilizing appropriate food simulating solvents;

Regulatory Status of Food Contact Material
Pursuant to FDA, the overall regulatory status of a food contact material is
dictated by the regulatory status of each individual substance that, because of
its intended use, is reasonably expected to migrate to food.
One of the following regulations may already be applied to each component:
Is present in a list of Title 21 Code of Federal Regulations (21 CFR)
Meets the criteria for GRAS status (Generally Recognize As Safe)
Is the subject of a letter of no objection (Prior Sanction Letter) before 1958,
of a petition presented by 1997 (Petition Regulation System), or, after 1997,
of a pre-market notification (Pre-Market Notification System)
Is the subject of a request for an exemption from the state of additive
(Threshold of Regulation (TOR) exemption request)
Is the subject of an effective notification (Food Contact Notification, Update
2004, and FDA Revision of Form FCN 3480-2006), but the clearance is
proprietary of the applicant.

21 CFR 174-179, to see if the use of the component is an appropriately
regulated indirect additive; or
21 CFR 182-186 and the list of GRAS Notices, to see if the use of the
component is Generally Recognized as Safe (GRAS); or
21 CFR 181, to see if the use of the component is Prior Sanctioned; or
The listing of Threshold of Regulation Exemptions; or
The listing o.f Effective Food Contact Substance Notifications
For each component that is not already regulated:
Submit a Threshold of Regulation Exemption Request; or
Submit a Food Contact Substance Notification; or
Satisfy the Criteria for GRAS status
continued: Regulatory Status of Food Contact Material
Documents to be consulted for each component:

General requirements
Ø It is the responsibility of the manufacturer to ensure that all the
components of a food contact object comply with the Federal Food, Drug,
and Cosmetic Act, verifying compliance if the composition is changed.
Ø The user of a food contact material may ask the supplier a "letter of
guaranty" (FD & C Act, Sec. 303 (c) (2)), with which it certifies that the
material is acceptable for the intended food contact.
Ø Currently, traceability of contact materials is not a law requirement (while
traceability is required by GMPs for medical devices).

Conclusion
ü All regulatory systems handled are based on:
Positive lists
Migration testing
Compliance declaration referring to the specific intended use
ü All regulations apply to food contact surface, whose correct identification
in the equipment is of primary importance
ü In Europe, traceability of food contact materials is compulsory all along the
chain of manufacture and use
ü In Europe, for many materials national laws are still in force, which in some
cases are different because not all updated
ü The USA and the European regulatory systems are substantially different

Thank you for your attention!
roberto.massini@unipr.it

Legal requirements for contact materials

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