Plastics Regulation EU 10/2011
Regulation (EU) No 10/2011 is a specific measure under the European Framework Regulation (EC) No 1935/2004 that sets out safety requirements for plastic materials and articles intended to come into contact with food.
- Scope: Regulation (EU) 10/2011 applies to plastic materials and articles, as well as their parts, which are intended to come into contact with food. This includes both final materials and articles as well as components such as layers, coatings, and adhesives.
- Purpose: The regulation aims to ensure that these plastic materials and articles do not transfer their components into food in quantities that could endanger human health or bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties.
- Compliance with Overall Migration Limits (OML): The total amount of substances migrating from the plastic into food must not exceed 10 mg per dm² of the food contact surface.
- Specific Migration Limits (SML): Specific substances have individual migration limits, which are defined to ensure safety.
- List of Authorized Substances: Only substances listed in the Union List (Annex I of the regulation) are authorized for use in the manufacture of plastic food contact materials.
- Good Manufacturing Practice (GMP): Plastic materials and articles must be manufactured in compliance with good manufacturing practices to ensure safety and quality.
Manufacturers and importers must provide a written Declaration of Compliance (DoC) for their plastic materials and articles, which confirms that they meet the requirements of Regulation (EU) 10/2011. The DoC must be supported by appropriate documentation and made available to competent authorities upon request.
- Testing: The regulation specifies test conditions for determining compliance with the migration limits.
- Documentation: Manufacturers must maintain adequate documentation to demonstrate compliance, including test reports and descriptions of production processes.
In addition the regulation requires that the composition of the substances used to manufacture the plastic materials and articles to be known to the manufacturer of the substance and made available to the competent authorities on request, in other words a bill of substance or ingredient list for a food contact article and/or material needs to be available.
Next to the general requirements, the regulation covers:
- a so-called “Union list” of authorised (approved) substances that can be used in the manufacture of plastic materials and articles for food contact purposes.
- which types of substances are covered by the Union list and which are not.
- restrictions and specifications for these substances.
- to which part of the plastic materials the Union list appliesand to which not.
- specific and overall migration limits for the plastic materials and articles.
In the EU polymers/plastics themselves are not approved or authorised for food contact, but the substances which could be present in and could potentially migrate into food have been authorised under certain conditions. The Union list, Table 1 of Annex I in the Regulation, contains in principle all substances that are approved/authorised to be present in the final plastic material, this includes monomers and other starting substances, as well as substances intentionally added to achieve certain plastic properties and polymer production aids (“PPA”).
Note: for PPAs, the Union list is not an exhaustive list. This means that PPAs others than those listed can be used in the manufacture of plastics.
If a substance on the Union list is used or present in the plastic, it has to comply with the specifications and migration limits set out in the list. If these substances are used in coatings, adhesives or printing inks that are part of the plastic materials within the scope the regulation, then the final material also has to comply with the relevant migration limits for these substances.
Relevant specifications as set out by the regulation for the use of substances could be:
- a restriction in relation to the food that may come in contact, e.g. “not to be used for articles in contact with fatty foods”;
- the restriction in relation to contact conditions, e.g. “only in repeated use articles”.
Note: The Union list is regularly updated with new and updated requirements for substance, latest amendment has been regulation (EU) 2016/1416 and will apply from 14 September 2017.
Plastic materials and articles should not transfer their constituents/substances to foods in amounts exceeding:
- the specific migration limits (SML) as listed in the Union list per substance
- an overall migration limit of maximum 10 milligrams of total substances released per dm2 of food contact surface (mg/ dm2).
Note: for products for infants and young children, the overall migration is a maximum of 60 milligrams of total of substances released per kg of food simulant.
Specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg). For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg applies.
Verification of compliance with the specific migration limits needs to be carried out in the food the product or materials wil be in contact with, or, more common, in specific foodsimulants as set- out in the regulation (see table 1). The different food simulates described in the regulation are intended to mimic “real” food.
Food simulants A, B and C are assigned for foods that have a so- called hydrophilic character (“water-soluble”) and are able to extract hydrophilic substances (“water soluble substances”):
- Food simulant A (ethanol 10% v/v) is mainly used for products made out of fruits, vegetables, eggs, meat and fish.
- Food simulant B (acetic acid 3% v/v) needs be used for those foods which have a pH below 4.5. like juices and vinegar
- Food simulant C (ethanol 20% v/v) needs be used for alcoholic foods with an alcohol content of up to 20 % and foods which contain a relevant amount of organic ingredients that make the food more lipophilic (“fat-soluble”), like coffee, syrups or jams.
Food simulants D1 (ethanol 50% v/v) and D2 (vegetable oil) are assigned for foods that have a lipophilic character (“fat-soluble”) and are able to extract lipophilic substances (fat-soluble and therefore not very water soluble substances):
- Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions, like milk and cheese.
- Food simulant D2 shall be used for foods which contain free fats at the surface, for example roasted foods.
Food simulant E (poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm) is assigned for testing specific migration into dry foods.
For certain food types it is possible multiple simulants need to be applied. More detailed information can be found in table 2 of Annex II of the regulation, where per different food type the most suitable standard foodsimulant has been provided.
Note: changes to foodsimulants for fruit and vegetables have been published with regulation (EU) 2016/1416 applicable from 14 September 2018
For the compliance testing itself the following general rules apply.
1) Verification method
Verification of compliance of migration into foods with the migration limits have to be carried out under the most extreme conditions of time and temperature foreseeable in the actual use of the product.
2) Sample preparation
The material or article has to be treated and tested as described by the instructions/manual or according to the details given in the declaration of compliance.
3) Test conditions
The sample has to be tested in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time (see table 1)
The following restrictions on plastic materials and articles apply:
Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.
| Table 1 | |||
| General list of migration limits for substances migrating from plastic materials and articles | |||
| ND: Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection. | |||
| Remarks | |||
| (1) The migration is subject to Article 11(3) and Article 12 | |||
| (2) The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature | |||
| (3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply. | |||
(4) The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that: (a) The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and (b) analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16. | |||
| (1) | (2) | (3) | (4) |
|---|---|---|---|
| Name | Salts allowed in accordance with Article 6(3)(a) | SML [mg/kg food or food simulant] | Remark |
| Aluminium | yes | 1 | |
| Ammonium | yes | – | (1) |
| Antimony | no | 0,04 | (2) |
| Arsenic | no | ND | |
| Barium | yes | 1 | |
| Cadmium | no | ND (LOD 0,002) | |
| Calcium | yes | – | (1) |
| Chromium | no | ND | (3) |
| Cobalt | yes | 0,05 | |
| Copper | yes | 5 | |
| Europium | yes | 0,05 | (4) |
| Gadolinium | yes | 0,05 | (4) |
| Iron | yes | 48 | |
| Lanthanum | yes | 0,05 | (4) |
| Lead | no | ND | |
| Lithium | yes | 0,6 | |
| Magnesium | yes | – | (1) |
| Manganese | yes | 0,6 | |
| Mercury | no | ND | |
| Nickel | no | 0,02 | |
| Potassium | yes | – | (1) |
| Sodium | yes | – | (1) |
| Terbium | yes | 0,05 | (4) |
| Zinc | yes | 5 | |
For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.
Food simulants
1.Food simulants
For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed in Table 1 below are assigned.
Table 1
List of food simulants
| Food simulant | Abbreviation |
|---|---|
| Ethanol 10 % (v/v) | Food simulant A |
| Acetic acid 3 % (w/v) | Food simulant B |
| Ethanol 20 % (v/v) | Food simulant C |
| Ethanol 50 % (v/v) | Food simulant D1 |
| Any vegetable oil containing less than 1 % unsaponifiable matter | Food simulant D2 |
| poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm | Food simulant E |
Textual Amendments
2.General assignment of food simulants to foods
Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.
Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for testing specific migration into dry foods.
Food simulant assignment for testing overall migration
For tests to demonstrate compliance with the overall migration limit food simulants shall be chosen as set out in Table 3:
Table 3
Food simulant assignment for demonstrating compliance with the overall migration limit
| Foods covered | Food simulants in which testing shall be performed |
|---|---|
| all types of food | 1.distilled water or water of equivalent quality or food simulant A;2.food simulant B; and3.food simulant D2. |
| all types of food except for acidic foods | 1.distilled water or water of equivalent quality or food simulant A; and2.food simulant D2. |
| all aqueous and alcoholic foods and milk products with a pH ≥ 4,5 | food simulant D1 |
| all aqueous and alcoholic foods and milk products with a pH < 4,5 | food simulant D1 and food simulant B |
| all aqueous foods and alcoholic foods up to an alcohol content of 20 % | food simulant C |
| all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % | 1.food simulant C; and2.food simulant B. |
Table 3
Standardised conditions for testing the overall migration
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Test number | Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing | Intended food contact conditions |
| OM0 | 30 min at 40 °C | Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes). |
| OM1 | 10 d at 20 °C | Any food contact at frozen and refrigerated conditions |
| OM2 | 10 d at 40 °C | Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes. |
| OM3 | 2 h at 70 °C | Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage. |
| OM4 | 1 h at 100 °C or at reflux | High temperature applications for all types of food at temperature up to 100 °C. |
| OM5 | 2 h at 100 °C or at reflux or alternatively 1 h at 121 °C | High temperature applications up to 121 °C. |
| OM6 | 4 h at 100 °C or at reflux | Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1. |
| OM7 | 2 h at 175 °C | High temperature applications with fatty foods exceeding the conditions of OM5. |
Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.
Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.
Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.
Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.
3.2.Substitute overall migration tests for tests with food simulant D2
If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.
In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.
| Test number | Test conditions | Intended food contact conditions | Covers the intended food contact conditions described in |
|---|---|---|---|
| OM8 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C | High temperature applications only | OM1, OM3, OM4, OM5 and OM6 |
| OM9 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C | High temperature applications including long term storage at room temperature | OM1, OM2, OM3, OM4, OM5 and OM6 |