'Use-by date' on biodegradable 'food contact materials'? The lawyer Dario Dongo responds

Dear Dongo Lawyer,

biodegradable 'food contact materials' (FCM) tend to degrade naturally over the years, regardless of their actual use as materials and objects intended to come into contact with food (MOCA), and yet they do not report on the label or data sheet a 'use-by date' technique, i.e. a deadline within which they can be used. Is there any regulatory requirement in this regard?

Thanking you for your valuable work in disseminating food law, I cordially greet you, Enrico


The lawyer Dario Dongo, Ph.D. in Agri-Food Systems, answers

Dear Enrico,

the general regulation of materials and objects intended to come into contact with food is contained in the now outdated Food Contact Materials Regulation (EC) No 1935/2004 (FCMR). (1,2) Regulation (EC) 2023/2006 then implemented the Good Manufacturing Practices (GMPs) then developed by the industry in relation to all groups of contact materials. (3)

FCMR had foreseen that the European Commission could adopt specific measures for certain groups of materials and their combinations, i.e. recycled materials to be used as raw materials. The use of plastic materials for the production of 'food contact materials' (or MOCA) was therefore the subject of specific measures, resulting in Regulation (EU) 10/2011. (4)

The Directorate General for Health and Food Safety (DG SANTE) then published a guide on the application of the regulation. (EU) no. 10/2011, specifically dedicated to the information to be provided within the supply chain. (5)

The general provisions on packaging and packaging waste are instead contained in Directive 94/62/EC - which will soon be replaced by the Packaging and Packaging Waste Regulation (PPWR) (6) - and in the Single Use Plastic Directive (EU) 2019/ 904 (SUPs), (7) which represents a lex specialis with respect to both the aforementioned regulation and Directive 2008/98/EC (Waste Framework Directive, WFD).

1) 'Food contact materials' in plastic and bioplastic, EU rules

The materials and objects made of plastic material - including bioplastics - can only be placed on the market if:

  • compliant with the requirements of the art. 3 of the reg. (EC) n. 1935/2004, under the foreseen and foreseeable conditions of use,
  • compliant with the labeling requirements referred to in the art. 15 of the reg. (EC) n. 1935/2004,
  • compliant with the traceability requirements referred to in art. 17 of the reg. (EC) n. 1935/2004,
  • manufactured in accordance with good manufacturing practices defined in the reg. (EC) n. 2023/2006, as well
  • compliant with the declaration and composition requirements referred to in chapters II, III and IV of the reg. (EU) no. 10/2011. (8)

1.1) General requirements

The general requirements provided for by the art. 3 of the FCMR require that materials and objects intended to come into contact with food are made in compliance with GMPs, to avoid the migration (under normal or foreseeable conditions of use) of their components into food products. (9)

The origin labelingFurthermore, the advertising and presentation of a material or object must not mislead consumers. (10)

1.2) Labeling

The mandatory information to be reported on the label of 'food contact materials' are:

  • name or company name and address of the manufacturer, processor or seller responsible for placing on the market, established in the European Union,
  • wording 'by contact with food products' or specific indication for use or symbol referred to in Annex II to Reg. (EC) No 1935/2004 (FCMR),
  • where appropriate, special instructions to be observed to ensure safe and adequate use,
  • batch or other identification code capable of ensuring the traceability of the material or object.

1.3) Declaration of conformity

The declaration of conformity of 'food contact materials' to the provisions in force follows the general rules set out in chapter IV of FCMR. The B2B sale of materials and objects intended to come into contact with food (MOCA) in plastic materials must be accompanied by a written declaration (11) from the responsible operator (12) capable of allowing easy identification of the products, to be renew if there are significant changes in composition or manufacturing that determine changes in migration from FCMs or new scientific data emerge in this regard.

Annex IV of Reg. (EU) 10/2011 indicates the information to be reported in the declaration of conformity:

  • identity and address of the economic operator issuing the declaration of conformity,
  • name or business name and address of the economic operator producing or importing the plastic materials or articles or the products at an intermediate stage of manufacture, as well as the substances intended for the manufacture of such materials and articles,
  • the identity of materials, objects, products at an intermediate stage of manufacture, as well as substances intended for the manufacture of those materials and objects,
  • date of declaration,
  • confirmation that the plastic materials or articles or products at an intermediate stage of manufacturing, as well as the substances mentioned above, satisfy the relevant requirements,
  • adequate information about the substances used or their degradation products,
  • adequate information on restricted substances in foodstuffs, obtained from experimental data or theoretical calculations on their specific migration levels and, where appropriate, purity criteria, so as to enable users of such materials or articles to comply with the relevant EU provisions or, in the absence of these, the national provisions applicable to foodstuffs,
  • specifications relating to the use of the material or object, such as: i) the types of food products with which it is intended to come into contact; ii) the duration and temperature of treatment and storage in contact with the food product; iii) the maximum ratio between the surface in contact with the food product and the volume for which conformity has been verified,
  • in case of use of a functional barrier in a multilayer material or article, confirmation that the said material or article complies with the requirements.

3) Conclusions

The applicable European regulations to 'food contact materials' in plastic and bioplastic do not even contemplate the concept of 'use-by date'. Where, if this information had been provided even only on an optional basis, the European legislator would have had to define the modalities as in fact happens in the Food Information Regulation (EU) No 1169/11.

The declaration of conformity in turn it does not provide anything on the conservation of packaging, focusing instead on the conditions of use following contact with food, including storage times and temperatures. And it is on this last topic, as seen, that the attention of industrial users of 'food contact materials' must be drawn.

Cordially

Dario

Footnotes

(1) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. Latest consolidated version 27.3.21 https://tinyurl.com/29fwwfa2

(2) Dario Dongo, Paolo Rebolini. Kitchenware and food contact materials, test conditions in EU. GIFT (Great Italian Food Trade).

(3) Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food. Consolidated text 17.4.08  https://tinyurl.com/2w4xckzj 

(4) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. Larest consolidated text 31.8.23 https://tinyurl.com/nhfw38ph 

(5) 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. https://food.ec.europa.eu/system/files/2016-10/cs_fcm_plastic-guidance_201110_reg_en.pdf  

(6) Marta Strinati. Packaging Regulation (PPWR), the European Parliament approves a softer version. GIFT (Great Italian Food Trade).

(7) Dario Dongo, Luca Foltran. SUP Directive, Legislative Decree 196/21. New rules on single-use plastic items from 14.1.22. GIFT (Great Italian Food Trade).

(8) Reg. (EU) No 10/2011, art. 4

(9) In quantities that a) constitute a danger to human health; b) result in an unacceptable change in the composition of food products; or c) lead to a deterioration of their organoleptic characteristics.

(10) FCMR, in recital 7, suggests particular attention to the labeling of active and intelligent packaging

(11) In accordance with art. 16 of the reg. (EC) n. 1935/2004.

(12) The natural or legal person responsible for ensuring compliance with the provisions of the Reg. (EC) n. 1935/2004 in the company placed under his control.



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