Frequently asked questions

For plastics, the information that must be included in a written declaration of conformity is listed in Annex IV of Regulation (EU) no. 10/2011. The document "Union guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs as regards information in the supply chain", details the content of the 9 headings described in Regulation (EU) No 10/2011 according to the role played by each operator in the supply chain:

• Manufacturers, distributors or importers of substances such as monomers and starting substances, additives, polymer production aids, ...;
• Manufacturers, distributors or importers of materials such as granules, flakes, thermoforming sheets, preforms, ... ;
• Manufacturers, distributors or importers of finished materials and objects such as packaging, culinary utensils, machine parts, ....

In the case of ceramics covered by Directive n°84/500/EEC, the declaration of conformity is described in the Order of 05/23/2006. It must accompany finished objects placed on the market up to the retail stage, excluding delivery to the end consumer.

Except for plastics and ceramics, the regulations give no precise indication of the content of written declarations of conformity to be communicated in the supply chain. Under French Decree no. 2007/766, amended by Decree no. 2008/1469, any operator supplying materials and articles intended to come into contact with food must provide its customers with a written declaration of conformity attesting to compliance with Articles 3 and 4 of Regulation (EU) no. 1935/2004. This obligation does not apply to materials and articles which, due to their characteristics, are clearly intended to come into contact with food. For all other materials, we recommend using the content of written declarations of conformity for plastics as a guide.

In application of the general safety obligation required in Directive n°2001/95/EC, any person responsible for the first placing on the national market of a product is subject to the general obligation of conformity defined by the French Consumer Code in its article L.212-1 of Book II - Title 1^er - Chapter II "General obligation of conformity":

"From the moment they are first placed on the market, products must comply with the requirements in force relating to personal health and safety, fair trading and consumer protection. The person responsible for first marketing a product is therefore required to check that it complies with current regulations. At the request of agents authorized to apply the present book, he must justify the checks and controls carried out".

The food contact suitability of materials and articles is guaranteed by those responsible for placing them on the market, established in the territory of the European Union. The latter must provide written declarations of conformity to their customers.

In the general fact sheet available on its website, the DGCCRF gives recommendations on information exchanges between operators responsible for placing materials and objects intended to come into contact with food on the market.

Regulatory requirements for food contact suitability are not defined in any of the so-called "new approaches" directives concerned by CE marking. Furthermore, there are no European standards describing specifications for food contact suitability. The only existing European standards in this sector describe analysis protocols.

The CE mark cannot therefore be used to demonstrate the food contact suitability of a finished material or object.

In the general recommendations on its website, the DGCCRF specifies that a validity period of up to 5 years is acceptable, provided that no changes likely to result in a modification of the inertia of the material or object have occurred during this period. If this is the case, the analyses will have to be repeated.

All materials and articles intended to come into contact with foodstuffs are subject to Regulation (EC) No. 1935/2004, which lays down the following rules:

"Materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer to foodstuffs constituents in a quantity liable to:

- present a danger to human health,

- lead to an unacceptable change in the composition of foodstuffs or an alteration in their organoleptic characteristics."

In France and for certain materials not subject to specific harmonized or national requirements, the DGCCRF gives recommendations so that operators can ensure compliance with Article 3 of Regulation (EC) n°1935/2004.

In the European Union, only recycled plastics are subject to specific regulatory requirements that allow mechanical recycling processes to be authorized.

In line with Regulation (EC) No. 1935/2004 and Regulation (EC) No. 2003/2006, Regulation (EC) No. 282/2008 lays down harmonized rules for authorizing recycling processes for plastics used in the manufacture of materials and articles intended to come into contact with foodstuffs. Chemical recycling processes and the use of recycled materials in situ or in a closed loop are not subject to these regulatory requirements.

To obtain authorization for their recycling processes, petitioners submit application dossiers to the authorities, and EFSA carries out a risk assessment based on the description of the processes, the characteristics of the incoming raw materials, the results of process efficacy tests and the characteristics of the recycled plastics, in particular their compliance with Regulation (EU) n°10/2011 (See EFSA's guidelines of 21/05/2008 on risk assessment dossiers). Authorizations are issued and entered in a register by the European Commission's Health and Food Safety Directorate on the basis of the opinions communicated by EFSA. Subsequently, authorized processes are monitored by member state authorities through inspections and audits of the quality assurance systems set up by operators.

For other categories of recycled materials, compliance with Article 3 of Regulation (EC) No. 1935/2004 must be demonstrated. In France, this is confirmed by an opinion issued on 7/11/93 by the CSHPF (Conseil Supérieur d'Hygiène Publique de France), which rules against the use of recycled materials that do not offer the same guarantees as the virgin materials they replace. As there are currently no specific regulatory requirements applicable to these other categories of recycled materials, professionals have published best practice guides giving recommendations on the use of recycled materials in the manufacture of materials and objects intended to come into contact with foodstuffs.

In the case of complex multi-layer or multi-material materials with a plastic layer, compliance with regulatory requirements is required if the existence of a functional barrier cannot be proven (See Regulation (EU) n°10/2011). Furthermore, according to Article 1^er of Regulation (EC) n°1935/2004, the regulatory requirements apply to materials or articles which are not in direct contact with food but which can reasonably be expected to transfer their constituents to food under normal and reasonably foreseeable conditions of use, which may be the case, for example, of secondary packaging used for the transport of pre-packaged food.

Article 15 of Regulation (EC) No. 1935/2004 requires that materials or articles intended to come into contact with food must bear one of the following three indications:

• The "glass/fork" symbol, which appears in Annex II of Regulation n°1935/2004 and is not mandatory;
  
• The words "suitable for food";
  
• A specific mention relating to employment.

These indications may appear on the articles, on their packaging or on signs in their immediate vicinity and in full view of purchasers, provided that, in the case of data identifying the person responsible for placing the articles on the market, this information cannot technically be affixed to the articles themselves at the manufacturing or marketing stage.

On the other hand, if, by virtue of their characteristics, the objects are clearly intended to come into contact with foodstuffs, then they are exempt from displaying one of these indications (e.g.: pieces of crockery, kitchen utensils, ...).

For plastic objects intended for reheating or cooking food in microwave ovens, compliance with migration limits must be demonstrated under contact conditions (duration and temperature) corresponding as closely as possible to actual use. To determine the most realistic conditions for migration testing, standard NF EN 14233 proposes a protocol for measuring the maximum temperatures reached when reheating food in a microwave oven. In addition, the DGGCRF gives recommendations for migration test conditions for plastic objects intended for reheating food in microwave ovens (Annex I of the recommendations applicable to plastics).

Bamboo is a grass, and as such, does not fall within the scope of the DGCCRF sheet concerning wood in contact with food.

For bamboo objects, no specific requirements are currently defined in France, or within the European Union. The requirements that do apply, however, are those common to all materials and objects intended to come into contact with food. Pending the publication of specific regulatory requirements for this material, we recommend using the criteria for plant fiber-based materials published on the DGCCRF website, and more particularly those used for paper and cardboard.

With regard to the use of bamboo as an additive, on June 27, 2019, a European Commission working group published a summary of discussions on the use and placing on the market of plastic objects containing ground bamboo or other similar constituents and intended for contact with food. The group's work was prompted by the fact that an increasing number of such objects are arriving on the EU market. These objects are generally made from melamine plastics.

The use of bamboo or other similar components as additives in the manufacture of materials and articles intended to come into contact with food, such as, for example, as fillers for plastics, requires authorization for use, in accordance with Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. To date, no authorization has been explicitly granted for bamboo. The working group clarified that wood flour and untreated fibers had indeed been authorized in Regulation (EU) n°10/2011 (Substance n°96). However, it has not been established that bamboo is included in this authorization, since it is a family of grasses and not wood. EFSA has therefore been asked to clarify this existing authorization.

Materials and articles in contact with drinking water used in public or private networks are excluded from the scope of Regulation (EC) n°1935/2004. To verify the suitability of these materials and articles for contact with drinking water, 4 EU member states (France, Germany, the Netherlands and the United Kingdom) proposed a common approach in 2011 called 4MS. In France, two laboratories are authorized to carry out analyses to issue ACS (Attestations de Conformité Sanitaire) in accordance with the protocols set out in the 4MS approach:

• Laboratoire EUROFINS de Maxeville (54) ;
• Laboratoire CARSO de Vénissieux (69).

All manufacturers who market materials and objects intended to come into contact with drinking water must obtain ACSs from one of these two laboratories. As these requirements are not harmonized, mutual recognition may apply between member states of the European Union. ANSES is responsible for risk assessment of substances used in the manufacture of materials and objects in contact with drinking water. The LHN laboratory in Nancy (54) is in charge of water analyses as part of the control of drinking water in France.

According to the EU guide "Union guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs as regards information in the supply chain", a single written declaration of conformity may cover a number of variations of a material or article that differ in size, shape, thickness or color in the source of supply of one or a few components, resulting in a limited number of variations in the substances to be declared, provided that all the substances to be declared are listed. Where applicable, the conformity assessment must cover all variations. The document must identify the items of a product family that it covers, and also indicate the product on which the written declaration is based. Documentation must be available to explain the reasons for the choice. Differences in substances to be declared due to variations in sources of supply must be reported.

According to the EU guide "Union guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs as regards information in the supply chain", communication of the identity of the substances in the written declaration of conformity is not compulsory if the customer is informed of the presence of these substances and if the company operator (supplier) has confirmed that the substances will not migrate beyond the migration limit if the material is used in accordance with the specified conditions of use. These derive from the results and conditions of tests to assess compliance with the overall migration limit or specific migration limits and other specifications required by Regulation (EU) No. 10/2011.

According to Article 16 of Regulation (EC) No. 1935/2004, documentation must be available to demonstrate conformity. According to Article 16 of Regulation (EU) No. 10/2011 applicable to plastics, this documentation indicates conditions, test results, calculations, including modeling, and other analysis results. It contains evidence of safety or arguments demonstrating compliance (e.g. written declaration of compliance from raw material suppliers, global migration analysis results, specific migration analysis results, substance migration prediction calculation results, proof of risk assessment for substances not listed in Annex I of Regulation (EU) n° 10/2011, demonstration of the existence of a functional barrier, ...).

Article 3 of Regulation (EU) no. 10/2011 states that a functional barrier may consist of one or more layers of any type of material where it ensures that the final material complies with the general requirement of Regulation (EC) no. 1935/2004 (Article 3) and that the migration level complies with the requirements of Regulation (EU) no. 10/2011. A functional barrier therefore prevents substances listed in Regulation (EU) no. 10/2011 and present in a layer behind the functional barrier from migrating beyond the SMLs. In addition, the migration of substances not listed in Regulation (EU) no. 10/2011 through the functional barrier to food-contact layers must not be detectable with an analytical method having a detection limit of at least 0.01 mg/ kg food or simulant. Barrier layer characteristics will influence substance diffusion (layer thickness and structure, migrant size and volume, temperature, contact time, solubility in food).

The term "functional barrier" is appropriate to describe situations characteristic of the migration of substances in polymers (Plastics, rubbers, silicones, cellulosic materials, ...). The thickness of a polymer layer that can be considered a functional barrier will depend on its nature, conditions of use (temperature, contact time) and the substance's characteristics (molecular mass, bulk).

In the case where no migration occurs through this layer, the term "absolute barrier" is appropriate. Examples of materials considered absolute barriers are glass and metals (Steel, aluminum, ...).

Article 17 of European regulation no. 1935/2004 requires traceability of materials and articles intended to come into contact with foodstuffs. Traceability must be ensured throughout the chain in order to facilitate controls, the withdrawal of defective products from the market, consumer information and the determination of responsibilities in the event of a dispute. All materials and objects placed on the market are subject to this obligation, whether or not they have been manufactured in the European Union, right up to the distribution stage. Each operator must ensure that he passes on essential information to his customers (contact details, article code and/or product name, production date and product identification). Traceability will be ensured if each player in the chain respects identification rules enabling them to trace back to their upstream suppliers.

In the case of materials and objects already in contact with food and sold to consumers (packaged foods), product marking (DDM or DLC, packaging date or batch no.) must make it possible to obtain packaging information from packagers. For materials sold to consumers and intended to come into contact with food, information must be maintained right through to distributors. Means are available to facilitate the identification of materials and objects (barcodes or RFID codes directly on the product, printed on labels or included in documentation). To facilitate the task of market operators, professionals have published guidelines for setting up traceability systems, in application of European regulations (See link to [Industrial guidelines on traceability of materials and articles for food contact]).

Regulation no. 1935/2004 stipulated that specific directives or regulations for the 17 material categories could include oral contact requirements. At present, the only such requirements concern elastomers used in teats and soothers. They are contained in Directive 93/11/EEC, which sets migration limits for nitrosamines and N-nitrosatable substances in reconstituted saliva.