Commission Regulation (EU) No 10/2011Show full title

3. Notes on verification of compliance U.K.

Table 3 on notes on verification of compliance contains the following information:

Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table 1 of this Annex.

Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-compliance.

Table 3

(1)	(2)
Note No	Notes on verification of compliance
(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.
[F1 (4)	Compliance testing when there is a fat contact [F2 shall] be performed using saturated fatty food simulants as simulant D2.]
(5)	Compliance testing when there is a fat contact [F2 shall] 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
[F3 (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]
[F4 (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]
[F5 (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.]
[F6 (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.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F2 Substituted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F3 Inserted by Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F4 Inserted by Commission Regulation (EU) No 202/2014 of 3 March 2014 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F5 Inserted by Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F6 Inserted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F7 Inserted by Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F8 Inserted by Commission Regulation (EU) 2018/79 of 18 January 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F9 Inserted by Commission Regulation (EU) 2019/37 of 10 January 2019 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

F10 Inserted by Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).