(5)

Annex V is amended as follows: (a) Section 1.4 of Chapter 1 is replaced by the following: ‘1.4. Account of substances originating from other sources In case there is evidence linked to the food sample that a substance partially or wholly originates from a source or sources other than the material or article for which the test is being carried out, the test results shall be corrected for the amount of that substance originating from the other source or sources before comparing the test results to the applicable specific migration limit’; (b) in Section 2.1.3 of Chapter 2, the text before Table 1 is replaced in its entirety by the following: ‘The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2. By way of derogation to the conditions set out in Tables 1 and 2, the following rules apply: (i) If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place; (ii) if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment; (iii) if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage. If the testing conditions representative for the worst foreseeable conditions of intended use of the material or article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst foreseeable conditions of intended use exceeds 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.’; (c) in Table 1, the title of the table is replaced by the following: ‘Selection of test time’; (d) in Table 1, the title of column 2 is replaced by the following: ‘Time to be selected for testing’; (e) Table 2 is replaced by the following: ‘Table 2 Selection of test temperature Worst foreseeable contact temperature Contact temperature to be selected for testing T ≤ 5 °C 5 °C 5 °C < T ≤ 20 °C 20 °C 20 °C < T ≤ 40 °C 40 °C 40 °C < T ≤ 70 °C 70 °C 70 °C < T ≤ 100 °C 100 °C or reflux temperature 100 °C < T ≤ 121 °C 121 °C (*) 121 °C < T ≤ 130 °C 130 °C (*) 130 °C < T ≤ 150 °C 150 °C (*) 150 °C < T < 175 °C 175 °C (*) 175 °C < T ≤ 200 °C 200 °C (*) T > 200 °C 225 °C (*) (f) Section 2.1.4 of Chapter 2 is replaced by the following: ‘2.1.4. Specific conditions for contact times above 30 days at room temperature and below For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C (**). (a) Testing for 10 days at 20 °C shall cover all storage times at frozen condition. This test can include the freezing and defrosting processes if labelling or other instructions ensure that 20 °C is not exceeded and the total time above – 15 °C does not exceed 1 day in total during the foreseeable intended use of the material or article. (b) Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. (c) Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at room temperature, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. (d) Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. (e) For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition. (f) For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) to (e), the testing time and temperature conditions shall be based on the following formula: t2 = t1 * Exp (9627 * (1/T2 – 1/T1)) t1 is the contact time t2 is the testing time T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25 °C). For refrigerated conditions it is set at 278K (5 °C). For frozen storage it is set at 258 K (– 15 °C). T2 is the testing temperature in Kelvin. (**) When testing at these accelerated test conditions the test specimen shall not undergo any physical or other changes compared to the real conditions of use, including a phase transition of the material.’;" (g) the first paragraph of Section 2.1.5 of Chapter 2 is replaced by the following: ‘If a material or article is intended for different applications covering different combinations of contact time and temperature the testing shall be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.’; (h) in Section 2.1.6 of Chapter 2, the third paragraph is replaced by the following: ‘The material or article shall respect the specific migration limit already in the first test for substances that are prohibited from migrating or from being released in detectable quantities under Article 11(4).’; (i) the first paragraph of Section 2.2 of Chapter 2 is replaced by the following: ‘To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered at least as severe as the verification method described in section 2.1.’; (j) Section 2.2.3 of Chapter 2 is replaced by the following: ‘2.2.3. Migration modelling To screen for specific migration, the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed in a way that must never underestimate real levels of migration.’; (k) Section 2.2.4 of Chapter 2 is replaced by the following: ‘2.2.4. Food simulant substitutes To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Section 2.1.2’; (l) in Section 2.2 of Chapter 2, the following paragraph 2.2.5 is added: ‘2.2.5. Single test for successive combinations of time and temperature If the material or article is intended for a food contact application where it is successively subject to two or more time and temperature combinations, a single migration contact test time can be defined based on the highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as described in point (f) of Section 2.1.4. The reasoning justifying that the resulting single test is at least as severe as the combined time and temperature combinations shall be documented in the supporting documentation provided for in Article 16.’; (m) Table 3 in Chapter 3 is replaced by the following: ‘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 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 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.’ (n) in Section 3.1 of Chapter 3, the paragraphs below Table 3 are replaced by the following: ‘Test OM7 also covers food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents the worst case conditions for food simulant D2 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 Section 3.2. Test OM6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B, C and D1 in contact with non-polyolefins. Test OM5 covers also food contact conditions described for OM1, OM2, OM3, and OM4. It represents the worst case conditions for all food simulants in contact with polyolefins. Test OM2 covers also food contact conditions described for OM1 and OM3.’; (o) Section 3.2 of Chapter 3 is replaced by the following: ‘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 OM1 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 specific migration shall be used to establish compliance with this Regulation. In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by either test OM8 or test OM9 as appropriate given the intended or foreseeable use. Both tests involve testing at two test conditions for which a new test sample shall be used for each test. The test condition that results in the highest overall migration shall be used to establish compliance with this 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’ (p) Section 3.3 of Chapter 3 is replaced by the following: ‘3.3. Verification of compliance 3.3.1. Single use articles and materials At the end of the prescribed contact time, to verify compliance the overall migration is analysed in the food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. 3.3.2. Repeated use articles and materials The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test. If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, it shall not be higher than the first result and the difference between the second and the first test results. By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration does not increase in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.’; (q) the first paragraph of Section 3.4 of Chapter 3 is replaced by the following: ‘To screen if a material or article complies with the migration limits, any of the following approaches can be applied which are considered at least as severe as the verification method described in Sections 3.1 and 3.2.’; (r) Section 3.4.2 of Chapter 3 is replaced by the following: ‘3.4.2. Food simulant substitutes To screen for overall migration, food simulants can be replaced if based on scientific evidence the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Annex III.’; (s) in Section 4.1 of Chapter 4, the fifth paragraph is replaced by the following: ‘The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.’; (t) in Section 4.1 of Chapter 4, the following paragraph is added: ‘When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.’; (u) Sections 4.2 and 4.3 of Chapter 4 are deleted.