Legal requirements for contact materials Roberto Massini

Transcription

1 Roberto Massini

2 Contents European legislation Supplementary Italian legislation US Federal legislation Conclusions

3 European legislation

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

5 Framework Regulation (EC) No 1935/2004 It sets: General principles Groups of food contact materials and articles Procedure for authorisation Contact materials: 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. Are manufactured according to good manufacturing practice. 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.

6 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.

7 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.

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

9 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 dm 2 of food contact surface (mg/dm 2 ).

10 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.

11 continued: Regulation (EU) No 10/2011 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; Requisiti di legge per i materiali a contatto

12 continued: ANNEX IV - Declaration of compliance 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. Requisiti di legge per i materiali a contatto

13 continued: Regulation (EU) No 10/2011 EU Guidances 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, _reg _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, Requisiti di legge per i materiali a contatto

14 Technical rules of individual European States

15 Principle of mutual recognition Regulation (EC) No 764/2008 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!

16 Supplementary Italian tecnical rules

17 Italian technical rules Are regulated, in particular, the following materials: stainless steels elastomers Requisiti di legge per i materiali a contatto

18 MD 21 March 1973 (as subsequently amended) Principles 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/ dm 2 o 50 mg/kg product ) 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 Requisiti di legge per i materiali a contatto

19 continued: MD 21 Marzo 1973 Chapter VI - Objects of stainless steel (D n. 258) 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: Cr 3+ 0,1 ppm; Ni 0,1 ppm; Mn 0,1 ppm. Requisiti di legge per i materiali a contatto

20 US Federal legislation

21 Regulatory status of components of food contact materials in the US 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 Requisiti di legge per i materiali a contatto

22 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 [ ]. Requisiti di legge per i materiali a contatto

23 Continued: Code of Federal Regulation Title 21 (21 CFR) 21 CFR 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 , 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. Requisiti di legge per i materiali a contatto

24 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 foodprocessing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed under of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in [ ] and, therefore, a food additive petition will not be required for the exempted use. 21 CFR Threshold of regulation for substances used in food-contact articles (a) Substance used in a food-contact article (e.g., food-packaging or foodprocessing 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, [ ] Requisiti di legge per i materiali a contatto

25 continued: 21 CFR (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; Requisiti di legge per i materiali a contatto

26 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 ), but the clearance is proprietary of the applicant.

27 continued: Regulatory Status of Food Contact Material Documents to be consulted for each component: 21 CFR , to see if the use of the component is an appropriately regulated indirect additive; or 21 CFR 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

28 General requirements 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. 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. Currently, traceability of contact materials is not a law requirement (while traceability is required by GMPs for medical devices).

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

30 Thank you for your attention! Requisiti di legge per i materiali a contatto