Since the last amendment to the Regulation, the European Food Safety Authority (‘the Authority’) has published further scientific opinions on particular substances that may be used in food contact materials (‘FCM’) as well as on the use of already authorised substances. In addition, certain ambiguities to the application of the Regulation were identified. In order to ensure that the Regulation takes account of the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected.

The Authority noted that, in light of the chemical characteristics of the isostructural lanthanide salts of terephthalic acid and of the four lanthanides (La, Eu, Gd, Tb) themselves, it is not necessary to restrict the use of these additives to the three polyolefin types of plastics specified in the application dossier that the applicant provided to the Authority. The Authority reasoned that no undesirable interactions with plastics (including, but not limited to polyolefins) leading to formation and possible migration of undesirable reaction and transformation products are to be expected. Like polyolefins, if migration from any plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food, and no further restrictions should be necessary. Therefore, it is appropriate to authorise the lanthanides for use in all types of plastic materials and articles as salts of already authorised substances, provided that these restrictions are met.

Article 10 of the Regulation sets out general restrictions related to plastic materials and articles, which are laid down in Annex II to the Regulation. Specifically, point 1 of this Annex restricts the migration of certain chemical elements from plastic materials and articles into food or food simulants. The chemical elements to which these limits apply may be present in plastic materials and Articles on the basis of several provisions set out in Chapter II of the Regulation. They may be present in the plastic because they are intentionally used as an additive or starting substance included in Annex I, or because their use is subject to a derogation under Article 6, including if they would be present in the plastic as an impurity or other non-intentionally added substance. The migration limits set in point 1 of Annex II to the Regulation therefore also apply to the metals which are present in the plastic material or article on the basis of Article 6(3)(a) of the Regulation. When the four lanthanides are added to the list of metals set out in Article 6(3)(a) their limits should therefore also be added to point 1 of Annex II.

The addition of the four lanthanides to Article 6(3)(a) further lengthens the list of substances set out in that provision. For reasons of clarity and good drafting practice such lists should not be set out in the enacting terms of the Regulation but in an Annex. As point 1 of Annex II already applies to most metals presently listed in Article 6(3)(a) this point can be used to also clarify whether it is permitted to use certain salts of these substances in accordance with Article 6(3)(a) without adding another list to the Regulation. It is therefore appropriate to clarify and simplify the Regulation by removing the names of the metals from Article 6(3)(a) and by amending Annex II to include them in point 1 of Annex II. For this purpose, it is appropriate to replace the present list of limits in point 1 of Annex II with a table that lists all metals presently included in Article 6(3)(a) and those included in point 1 of Annex II and with the specific conditions of use and migration limits of those metals. As Article 6(3)(a) also provides that ammonium salts of authorised acids, alcohols and phenols are authorised in the same way as the specified metals, it is appropriate that ammonium is also included in point 1 of Annex II.

The substance 1,3 phenylenediamine (CAS No 0000108-45-2, FCM No 236) is a Primary Aromatic Amine currently included in Annex I of the Regulation to be used as a starting substance in plastic materials and articles intended to come into contact with food provided it does not migrate. However to verify compliance with this requirement it should not be detected in the food or the food simulant above the 0,01 mg/kg food or food simulant detection limit, in accordance with the second subparagraph of Article 11(4) of the Regulation. The advances in analytical capabilities allow the detection of 1,3 phenylenediamine at 0,002 mg/kg food or food simulant. It is therefore appropriate to amend Annex I of the Regulation to set this value as a specific detection limit for this substance to reflect this improvement in analytical capability and to maximise the health protection of consumers.

The Authority has adopted opinions on arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and mercury (Hg). These metals are not included in Annex I of the Regulation and therefore are not authorised to be used in plastic materials and articles intended to come into contact with food. The adverse health effects of these metals are well established and transfer of these metals from plastics materials and articles to food should not occur at levels harmful to human health. While the levels of these metals are normally brought under control during the subsequent manufacturing stages of plastic materials and articles in accordance with Article 4(d) of the Regulation, these metals can nevertheless end up being present as impurities in final plastic materials and articles based on the derogations set out in Article 6(4)(a), and adversely affect the health of the consumer. While the safety of these metals should principally be controlled in accordance with Article 19 of the Regulation and the documentation provided according to the provisions of Articles 15 and 16 of the Regulation, such work may not be implemented uniformly, and is burdensome and difficult to verify by competent authorities. Clearly defined migration limits based on opinions of the Authority would allow uniform analytical verification of compliance. It is therefore appropriate to amend Annex II of the Regulation to establish limits on the migration of these metals to ensure a uniform approach to verification of compliance, the application of a uniform level of health protection, and the proper functioning of the single market.

The Authority established a TDI of 0,3 mg/kg body weight per day for trivalent chromium for diffuse duodenal epithelial hyperplasia and haematotoxicity. The Authority estimated that the dietary intakes of trivalent chromium for average and high level consumers in Europe amount to 5 and 8 % of the TDI respectively. Based on the TDI and on a 20 % allocation factor to account for the contribution of exposure to chromium from sources other than plastic materials and articles intended to come into contact with food and taking into account conventional exposure assumptions for food contact materials, a specific migration limit of 3,6 mg trivalent chromium/kg food or food simulant is appropriate. It is therefore appropriate to amend Annex II of the Regulation to include trivalent chromium provided that the migration from plastic materials and articles intended to come into contact with food does not exceed 3,6 mg trivalent chromium/kg food or food simulant.

In addition, the Authority also established a benchmark dose (at 90 % confidence limit) (‘BMDL₁₀’) of 1,0 mg/kg body weight per day for hexavalent chromium. Since this species of chromium is genotoxic and carcinogenic, the Authority considered that a Margin of Exposure (‘MOE’) above 10 000 is required for the exposure to be of low concern. Taking into account the BMDL₁₀, the minimum MOE of 10 000, a 20 % allocation to account for the contribution of exposure to hexavalent chromium from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of hexavalent chromium from plastic materials and articles intended to come into contact with foods should not exceed the level of 0,0012 mg hexavalent chromium/kg food or food simulant to exclude adverse health effects. However, according to the EURL-FCM reliable detection of total chromium in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore it advised to retain the detection limit for chromium of 0,01 mg/kg food instead.

There is a large difference in toxicity between trivalent and hexavalent chromium and it is difficult to distinguish between the two chromium species without using burdensome analytical methods. Therefore, verifying compliance with the Regulation of plastic materials and articles that may contain chromium should be done on the basis of hexavalent Chromium as this is the most toxic species. Annex II of the Regulation should therefore be amended to include the detection limit as the limit for chromium migration into food or food simulant. The migration of all chromium, regardless of its oxidation state, from plastic materials and articles intended to come into contact with foods, should therefore not be detectable in food or food simulant above the level of 0,01 mg/kg food or food simulant. However, if the business operator placing the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material can be excluded because it is not used or formed during the entire production process, the migrating species should be considered trivalent chromium only and therefore a migration limit of 3,6 mg/kg food should apply in accordance with the second subparagraph of Article 11(4) of the Regulation. It is therefore appropriate to amend Annex II to the Regulation.

Lead should not be used intentionally to manufacture a plastic material, but it can be present as an impurity. As its presence cannot be fully prevented, and it can cause health effects at any level of exposure, there should be uniform rules to ensure its presence can be controlled. It is therefore appropriate to establish a common limit for its migration from plastic materials. In absence of a health based guidance value the BMDL₀₁ value of 0,5 μg lead/kg body weight per day is used as basis for that limit. Lead exposure however occurs from many sources other than from articles and materials intended to come into contact with food. To derive a limit for the migration of lead from plastic materials and articles intended to come into contact with food, it is therefore appropriate to apply a conventional allocation factor of 10 %, to account for the contribution of lead from materials and articles intended to come into contact with food to the total lead exposure. Taking into account conventional exposure assumptions for such materials and articles, and assuming an average body weight of 60 kg, the migration of lead from plastic materials and articles intended to come into contact with food should not exceed 0,003 mg/kg food in food or food simulant in order to reduce the probability of adverse health effects to a minimum. However, according to the EURL-FCM reliable detection of lead in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to assign a detection limit for lead at 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly.

Primary aromatic amines (‘PAAs’) may be used in plastic food contact materials as colorants or may be present as not intentionally added substances in accordance with Article 6 of the Regulation. PAAs are a large family of compounds, some of which are carcinogens, while others are suspected carcinogens. Certain PAAs may have adverse effects at any migration level, therefore they should not migrate into the food. However, it is not possible to exclude their migration analytically, as analytical methods can only exclude migration above their limit of detection. For the purpose of compliance verification, and to ensure legal certainty, the migration of PAAs into food has been restricted to a specified level that is not detectable in the food or food simulant by means of commonly used analytical methods. However, according to the EURL-FCM advances in analytical capabilities ensure that equipment is now commonly available that allows to lower the detection limit of 0,01 mg/kg food or food simulant that the Regulation presently assigns to the detection of individual PAAs to a new detection limit of 0,002 mg/kg food or food simulant. Therefore that lower detection limit should be defined in the Regulation as the detection limit for individual PAAs.

Point 2 of Annex II to the Regulation requires that the sum of PAAs does not exceed 0,01 mg/kg food or food simulant, to avoid that their collective presence can cause adverse health effects. As the limit of detection is now lowered to 0,002 mg/kg food or food simulant for all PAAs listed in the Azocolourants entry, the sum would not require evaluation if such a PAA is detected because the material would not be in compliance with the Regulation anyway in this case. However, when it is known or suspected that certain PAAs not listed in Annex I or in the Azocolourants entry may be present, their presence can be assessed on the basis of migration testing and modelling considerations. Therefore, it is appropriate to maintain the provision that the sum of those PAAs does not exceed 0,01 mg/kg food or food simulant.

The new or updated restrictions on substances in Annex II require clear communication in the supply chain to ensure that adequate information on the presence of these substances is available to business operators which use products from intermediate stages in the supply chain or final articles or materials in which these substances may be contained. When such information is not provided they cannot be certain on the presence and amount of these substances and they would need to test more frequently than would be needed if that information was provided. However, if the presence and amount of these substances is known to these business operators, in many cases simple calculation techniques can suffice to establish whether a limit could be exceeded, and analytical testing would not be required at all. Moreover, communication of the amounts of substances is also required to communicate on the presence of these substances to later stages of the supply chain. Therefore, it is appropriate to amend point 6 of Annex IV to the Regulation to clarify that the amount of substances subject to limits under Annex II should be included in the declaration of compliance.

Before placing an intermediate or final product on the market, the manufacturer of that product needs to assess whether it complies with Article 3 of Regulation (EC) No 1935/2004, and/or complies with Article 19 of the Regulation. Various and complementary approaches should be used in such assessment. A common and cost efficient testing approach is to determine only the safety of substances that are present above a concentration of 10 ppb by using migration testing with a food simulant. Substances that do not exceed this limit are then considered safe. However, the migration of substances at a level of 10 ppb can only be considered safe provided that their genotoxicity can be ruled out. Therefore, the use of such a testing technique should always be complemented by an assessment of whether substances that could be genotoxic are present. Therefore, it should be communicated to downstream users of an intermediate or final material that it may contain substances of which the genotoxicity has not been ruled out. Producers of intermediate materials know that these substances can be present in their products as they use preparations that contain them, or should obtain that information from their suppliers. Therefore, point 6 of Annex IV should also be clarified to require information on substances present in a material or article, of which genotoxicity has not been ruled out.

Point 2.1.6 of Annex V to the Regulation requires three subsequent tests for articles and materials that are placed in repeated contact with food. The results of the third migration test should be used to verify compliance with the migration limits. However, if the migration was to increase between the first, second and third test, the tests would not be suitable to verify compliance even in cases where the specific migration limit is not exceeded in any of the three tests, as they will not adequately predict the final migration level after continued contact with food. Thereto the migration should be strictly decreasing in subsequent tests. While this principle is already reflected in the second subparagraph of point 2.1.6 on conditions to use the results of the first test, as well as in point 3.3.2 on overall migration testing, a requirement that the migration should not increase between subsequent tests was not specified in the first paragraph of point 2.1.6. It would therefore be appropriate to amend the Regulation and add this requirement. However, in some instances, such as when migration is low relative to the measurement error, it may be difficult to establish a decreasing trend analytically and it would require complex rules. Therefore it is appropriate to only require that a the migration established in a subsequent test does not exceed that of the previous test, to clarify this principle in the Regulation, and to establish that a material that shows increasing migration over the subsequent tests should never be considered compliant.

Annex V provides rules for the tests to demonstrate the compliance of migration from plastic materials and articles intended to come into contact with food with the migration limits referred to in Articles 11 and 12 of the Regulation. Certain types of plastic materials and articles are intended to come to contact with food only at cold or ambient temperatures and for a short duration (less than 30 minutes). While conditions for the specific migration testing for such intended contact are available, corresponding conditions for the overall migration testing are not assigned in Table 3 of Annex V of the Regulation. The Overall Migration (OM) testing condition 2 (OM2), which requires testing at 40 °C for 10 days, and the OM3, which requires testing at 70 °C for two hours, are the two OM test conditions which come close in simulating the intended food contact conditions for these types of kitchenware but they are significantly more severe than the real life conditions which could foreseeably occur during actual use of such kitchenware. Therefore it is appropriate to amend Table 3 of Annex V of the Regulation and the relevant text below that table to introduce overall migration conditions of 30 minutes at 40 °C designated as OM0 for the overall migration testing of plastic kitchenware materials and articles only at cold or ambient temperatures and for a short duration.

Migration testing at 100 °C can be technically difficult in some situations because of high evaporation of water. In order to overcome this difficulty and to ensure that migration testing can be properly conducted, a reflux condition may be used as an alternative to test for specific and overall migration at 100 °C. Such a reflux condition is provided for as an option in the OM5 and OM6 test conditions in Table 3 of Annex V of the Regulation which require testing at 100 °C. A reflux alternative testing condition is not provided for the OM4 test condition which also requires testing at 100 °C. It is therefore appropriate to amend the OM4 entry in Table 3 of Annex V of the Regulation to provide for the reflux condition as an option when testing at 100 °C is technically difficult.

Migration testing using the whole equipment or appliance for food processing and/or food production is presently not allowed under the Regulation. However, when food processing equipment or appliances are made of multiple plastic parts, or contain plastic parts as well as other materials, it may be burdensome and in some cases impossible to verify compliance of these plastic parts with the Regulation. It should therefore be possible to verify compliance by conducting migration tests in the food or food simulant produced or processed using the whole equipment or appliance, or assemblies or modules thereof, in accordance with the operating instructions, instead of trying to establish the migration from each individual plastic part or material used in the equipment or appliance. If such a migration test is done under the worst foreseeable use conditions in the food, or when appropriate, in a food simulant, which can be achieved in accordance with the operating instructions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the specific migration limits, the plastic parts of the food processing equipment should be considered to comply with the requirements of Article 11(1) of the Regulation if the plastic parts comply with the compositional provisions set out in the Regulation. It is therefore appropriate to amend Annex V of the Regulation to introduce provisions that will allow for the migration testing with the whole equipment or appliance for food processing and/or food production, instead of verifying the compliance of each of its individual parts.

Applying the whole equipment or appliance in accordance with its operating instructions to prepare the food, or parts thereof may not be representative for all of its parts. Certain parts will be subject to different contact conditions, in particular those parts that are used for storage, in some cases long term, such as containers, reservoirs, capsules, and pads. Those parts would need to be tested also separately to ensure they are safe for those storage conditions as well.

Migration testing of food processing and/or food producing equipment or appliance can only establish the compliance of the equipment with the Regulation. However, in case a non-compliant migration is observed when testing food processing and/or food producing equipment or appliances, it should be verified that this migration does not originate from materials not subject to the Regulation. Therefore, it is appropriate to require to establish whether the source of the non-compliance is a plastic part of the equipment or appliance, or whether it is another material not subject to the Regulation. The non-compliance of the equipment with the Regulation should then only be established if that non-compliance is due to a plastic part.

The first paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of food simulant D2 with 95 % ethanol and isooctane in the overall migration (OM) tests 1-6 referred to in Table 3 of Annex V, when it is not technically feasible to perform one or more of the OM tests 1-6 with the simulant D2. The third sentence of that paragraph erroneously makes reference to specific migration rather than to overall migration. It is therefore necessary to correct that sentence.

The second paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of the overall migration (OM) test 7 with the OM tests 8 or 9 when it is not technically feasible to perform the OM test 7 with simulant D2. The wording of that paragraph does not clearly specify by which test OM 7 should be substituted, and makes reference to the highest overall migration in the last sentence, which could be erroneously interpreted in such a way that more than two OM tests should be conducted. It is therefore appropriate to clarify the paragraph by laying down that one test should be selected and by referring to the higher overall migration obtained under the two testing conditions required in that test.

Regulation (EU) No 10/2011 should therefore be amended and corrected accordingly.

Plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the date of the entry into force of this Regulation, and which were also placed on the market before that date, should be allowed to be placed on the market for two more years and remain on the market until the exhaustion of stocks. However, this long period should not be used to develop new materials and articles which had not yet been placed on the market at the time of entry into force of this Regulation, and are not yet compliant with it. Business operators may not be able to fully anticipate the entry into force of this Regulation when they would have been already planning to place such new materials on the market before the entry into force of this Regulation. Therefore it is appropriate to allow such placing on the market of new materials and articles based on the old rules for six months after the entry into force of this Regulation.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,