SCHEDULE 3Overall and Specific Migration Testing Using Food Simulants
PART 3Selection of Food Simulants
Testing, reduction factors and definition of food types
1
The testing of plastic materials and articles shall be carried out under the test conditions specified in Part 5 using a simulant or simulants selected in accordance with this Part and taking a new test specimen of the plastic material or article for each simulant used.
2
1
Where a test is carried out on a plastic material or article intended to come into contact with more than one food or group of foods and a reduction factor is specified for one or more of those foods or groups of foods which is not equivalent to the reduction factor specified for one or more of the other foods or groups of foods with which the plastic material or article is intended to come into contact–
a
the reduction factor specified for each food or group of foods, as appropriate, shall be applied to the test result; and
b
the plastic material or article shall be treated as being capable of transferring its constituents to food with which it may come into contact in excess of a migration limit specified in regulation 9 or the Annexes if, following application of those specified reduction factors, one or more of the results show that the material or article does not comply with that specified migration limit.
2
For the purpose of this paragraph–
a
a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to Part 4;
b
a reduction factor is specified for a food or group of foods where, in the Table to Part 4–
i
the food or group of foods is described in the column headed “Description of food”, and
ii
“X” is placed in a column headed by a specified simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor;
c
a reduction factor shall be applied to a test result by dividing the result by that reduction factor.
3
Food types are defined in Table 1 as follows–
Definition | Meaning |
|---|---|
Aqueous foods having a pH > 4.5 | Foods in relation to which stimulant A only is specified in the Table to Part 4 |
Acidic foods having a pH < 4.5 | Foods in relation to which stimulant B only is specified in the Table to Part 4 |
Alcoholic foods | Foods in relation to which stimulant C only is specified in the Table to Part 4 |
Fatty foods | Foods in relation to which stimulant D only is specified in the Table to Part 4 |
Dry Foods | Foods in relation to which no simulant is specified in the Table to Part 4 |
Selection of simulants for testing materials and articles intended for contact with all food types4
The simulants to be used in testing a plastic material or article which is intended for contact with all food types are stimulant B, stimulant C and stimulant D which, at the test conditions specified in Part 5, are considered to be more severe.
Selection of simulants for testing materials and articles which are already in contact with a known food5
The simulant or simulants to be used in testing a plastic material or article which is already in contact with a known food shall be–
a
where–
i
the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part 4 and,
ii
for the purposes of that Part, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods,
the simulant or simulants so specified;
b
where–
i
the known food is neither a specific food, nor
ii
within a specific group of foods described in the Table to Part 4 of this Schedule,
the simulant or simulants in column 2 of Table 2 opposite the description of food in column 1 of that Table which corresponds most closely to the known food.
Selection of simulants for testing materials and articles which are accompanied by a specific indication
6
The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation 1935/2004 is accompanied by a specific indication stating any type or types of food described in Table 1 with which it may or may not be used shall be the simulant or simulants in column 2 of Table 2 opposite the contact food in column 1 of that Table which corresponds most closely to the type or types of food with which it may be used, as identified by the indication which accompanies the plastic material or article.
7
The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation 1935/2004, is accompanied by a specific indication, expressed in accordance with paragraph 8, stating any food or group of foods described in the Table to Part 4 with which it may or may not be used shall be–
a
where the indication states that the plastic material or article may be used with a food or group of foods described in column 2 of the Table to Part 4, the food simulant or food simulants which, for the purposes of Part 4, is or are specified in relation to that food or group of foods;
b
where the indication states that the plastic material or article should not be used with any food or group of foods described in column 2 of Table to Part 4, a simulant other than the one specified for the purposes of Part 4 in relation to that food or group of foods.
8
A specific indication referred to in paragraph 7 is expressed in accordance with this paragraph if it is expressed–
a
at a marketing stage other than retail, by using the reference number in column 1 of the Table to Part 4 or the description of food in column 2 of that Table which, in either case, corresponds to the food;
b
at the retail stage, by using an indication which refers to only a few foods or groups of foods described in the Table to Part 4.
Contact foods | Simulant |
|---|---|
Only aqueous foods | Simulant A |
Only acidic foods | Simulant B |
Only alcoholic foods | Simulant C |
Only fatty foods | Simulant D |
All aqueous and acidic foods | Simulant B |
All alcoholic and aqueous foods | Simulant C |
All alcoholic and acidic foods | Simulant C and B |
All fatty and aqueous foods | Simulants D and A |
All fatty and acidic foods | Simulants D and B |
All fatty, alcoholic and aqueous foods | Simulants D and C |
All fatty, alcoholic and acidic foods | Simulants D, C and B |