(1)

(2)

(1)

Verification of compliance by residual content per food contact surface area (QMA) pending the availability of an analytical method.

(2)

There is a risk that the SML or OML could be exceeded in fatty food simulants.

(3)

There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the final product does not comply with Article 3(1) c of the Framework Regulation (EC) No 1935/2004.

F4(4)

Compliance testing when there is a fat contact F1shall be performed using saturated fatty food simulants as simulant D2.

(5)

Compliance testing when there is a fat contact F1shall be performed using isooctane as substitute of simulant D2 (unstable).

(6)

Migration limit might be exceeded at very high temperature.

(7)

If testing in food is performed, Annex V 1.4 shall be taken into account.

(8)

Verification of compliance by residual content per food contact surface area (QMA); QMA = 0,005 mg/6 dm².

(9)

Verification of compliance by residual content per food contact surface area (QMA) pending the availability of analytical method for migration testing. The ratio surface to quantity of food shall be lower than 2dm²/kg.

(10)

Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.

(11)

Only a method of analysis for the determination of the residual monomer in the treated filler is available.

(12)

There is a risk that the SML could be exceeded from polyolefins.

(13)

Only a method for determination of the content in polymer and a method for determination of the starting substances in food simulants are available.

(14)

There is a risk that the SML could be exceeded from plastics containing more than 0,5 % w/w of the substance.

(15)

There is a risk that the SML could be exceeded in contact with foods with high alcoholic content.

(16)

There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods

(17)

Only a method for determination of the residual content of the substance in the polymer is available

F5(18)

There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)

(19)

There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers

F6(20)

The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary

F3(21)

In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.

F2(22)

When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1.

(23)

When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

F7(24)

The substance or its hydrolysis products are authorised food additives and compliance with Article 11(3) shall be verified.

F8(25)

When used as reheat agent in polyethylene terephthalate (PET) verification of compliance with the specific migration limit is not required; in all other cases compliance with the specific migration limit shall be verified in accordance with Article 18; the specific migration limit is expressed as mg tungsten/kg food.

(26)

Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specific migration limit applies, shall be excluded from verification of the compliance of the migration of the mixture with the specific migration limit laid down for the mixture.

F9(27)

When a final material or article containing this substance and produced under conditions other than those described in point (a) column 10 of Table 1 is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in point (b) column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

F10(28)

A detection limit of 0,002 mg/kg food or food simulant applies

(29)

In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.