PRIMER REQUERIMIENTO AL DIPUTADO JUAN JOSÉ GUERRA ABUD, COORDINADOR DEL GRUPO PARLAMENTARIO DEL PARTIDO VERDE

Regulation No. 10/2011 sets that, to determine the extent of chemical transfer from FCMs into food, migrants are not to be measured in actual foodstuffs, but in food simulants. Only for materials and articles that are already in contact with the food the compliance testing shall be carried out in the food itself.

When the materials or article is not into contact with the food, verification of compliance is to be carried out in food simulants. These food simulants are used as substitutes for food due to simplification of the chemical analysis. They vary in terms of their chemical properties, thus representing several particular food types: hydrophilic (water-based), lipophilic (fatty foods) or amphiphilic (foods with both watery and fatty properties). Butter and other amphiphilic foods are for example simulated by a 50% ethanol in water solution. For oily foods, vegetable oil is the prescribed food simulant, whereas simulants 10% ethanol or 3% acetic acid in water have to be applied for water- based foods and drinks. For dry foods, a synthetic polymer with a defined pore size, namely poly(2,6-diphenyl-phenylene oxide), also commercially known as Tenax, is to be used as a simulant (Table 1.4).

Testing is performed by putting the material into contact with the appropriate simulant. Testing conditions, such as time and temperature, are selected taking into consideration the final use of the item, respecting the worst case principle and consequently selecting the highest possible temperature and the longest period of time, considering the worst reasonably foreseeable final use (Table 1.5).

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Table 1.4: List of food stimulants as defined in EU Regulation No. 10/2011

Reference Simulant Food type

A 10% Ethanol Aqueous Food

B 3% Acetic acid Foods that have a hydrophilic character and are able to extract hydrophilic substances and which have a pH below 4.5

C 20% Ethanol Foods that have hydrophilic character and are able to extract hydrophilic substances, alcoholic foods with alcohol content of up to 20 % and foods containing a relevant amount of organic ingredients that render the food more lipophilic D1 50% Ethanol Alcoholic foods with an alcohol content of

above 20 % and dairy products

D2 Vegetable oil Fatty food and foods which contain free fats at the surface

E poly(2,6-diphenyl-

phenylene oxide), particle size 60-80 mesh, pore size 200 nm

Dry foods

Table 1.5: Selection criteria for contact time (left) and temperature (right) for specific migration testing. Time and temperature are selected independently of each other.

Contact time in worst

foreseeable use Test time

Contact temperature in worst foreseeable use Test temperature t ≤ 5 min 5 min T ≤ 5 °C 5 °C

5 min < t ≤ 0.5 hour 0.5 hour 5 °C < T ≤ 20 °C 20 °C 0.5 hours < t ≤ 1 hour 1 hour 20 °C < T ≤ 40 °C 40 °C 1 hour < t ≤ 2 hours 2 hours 40 °C < T ≤ 70 °C 70 °C

2 hours < t ≤ 6 hours 6 hours 70 °C < T ≤ 100 °C 100 °C or reflux temp 6 hours < t ≤ 24 hours 24 hours 100 °C < T ≤ 121 °C 121 °C (*)

1 day < t ≤ 3 days 3 days 121 °C < T ≤ 130 °C 130 °C (*) 3 days < t ≤ 30 days 10 days 130 °C < T ≤ 150 °C 150 °C (*) Above 30 days Specific 150 °C < T < 175 °C 175 °C (*)

conditions specified

T > 175 °C Adjust temperature to real temperature at interface with food (*)

(*) means that this temperature shall be used only for food simulants D2 and E. For applications heated under pressure migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the time conditions in the left side of the table.

1.5.3.1 Specific migration

Within the regulations, table 1 of Annex I in the Regulation provides the European Union’s list of the authorised chemicals which can be used in the production of articles intended to be in contact with foodstuffs. It also lists the way the chemical is authorised to be used, for example as an additive or a monomer unit. However, for many of these chemicals, there are limits for the amounts which can be released into the food (SML). SMLs are fixed on the basis of a toxicological evaluation and are set according to the acceptable daily intake (for authorised substances) or the tolerable daily intake (for contaminants) established by the Scientific Committee on Food. The limit is set on the assumption that every day throughout an individual’s lifetime, a person weighing 60 kg eats 1 kg of food packed in plastics containing the substance in the maximum permitted quantity. For substances for which no SML or other restrictions are provided in Annex I of the Regulation, a generic SML limit of 60 mg kg-1 applies. Specific migration testing is performed according to the previously described conditions to assess migration for the individual authorised (and unauthorised) substances. If the material or article is intended to come into repeated contact with foods (such as baby bottles), the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test. However, when the specific migration limit is set as non-detectable (in practice detection < 10 µg kg-1) and for non-listed substances behind a plastic functional barrier these limits already have to be respected in the first migration test (European Union 2011b).

1.5.3.2 Overall migration

The overall migration limit (OML) is the maximum permitted amount of non-volatile substances that can be released into the food. This is determined by exposing a product to an (aqueous) simulant for a specified length of time, after which the extracted residue is dried (105-110 °C) and weighed. When vegetable oil is to be used as a simulant, the overall migration in the oil is determined as the loss in the mass of specimens after the contact with the simulant.

There are two requirements for the OML:

 No more than 10 mg of total constituents can be released per dm2 of food contact surface (mg/dm2)

 In cases where the item is intended to be brought into contact with food for infants and young children, the overall migration cannot exceed more than 60 mg of total of constituents released per kilogram of food simulant (mg/kg).

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