On September 3, 2020, the European Union issued the (EU) No 10/2011 Amendment Regulation (EU) 2020/1245, which made important updates to (EU) No 10/2011. This is the 15th revision since Regulation (EU) No 10/2011 was issued. CIRS C&K testing will take you to understand the main contents of this revision as follows.

Table 1 Revision overview

Authorized substances and limit requirements

Amended the entry in Annex 1

Amended the specific migration limit requirements for plastic materials and products in Annex 2, and added some metal elements (total 24 types), reduced the detection limit of primary aromatic amines.

Information transmission requirements

Amended the requirements of Annex IV, point 6 regarding the delivery of the declaration of conformity.

Compliance test requirements.

Added test requirements for food processing and/or food producing equipment or appliance.

Repeated products should be based on the results of the third migration, and the stability of the material or product from the first to the third migration test, to verify compliance.

Added the test standard condition OM0 for overall migration, amended the test standard condition OM4 for overall migration.

Effective time

Effective after 20 days from 3 September 2020 (September, 23rd, 2020)

Transition period

Plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the entry into force of this Regulation, and which were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until the exhaustion of stocks.

Main amendments

1. Authorized substances and limit requirements

Amended the specific migration limit requirements for plastic materials and products in Annex 2, and added some metal elements (total 24 types)

Table 2 Specific migration limit requirements for metal elements

Regulations

#

Elements

SML (mg/kg)

Remark

(EU) No 10/2011 and its amendment regulations (as of (EU) 2019/1338)

1

Barium

1

 

2

Cobalt

0.05

3

Copper

5

4

Iron

48

5

lithium

0.6

6

Manganese

0.6

7

Zinc

5

8

Aluminum

1

9

Ammonium

-

10

Calcium

-

11

Magnesium

-

12

Potassium

-

13

Sodium

-

This time added

14

Europium

0.05

The salts of lanthanide substances (europium, gadolinium, lanthanum, and/or terbium) can be used in accordance with
Article 6(3)(a) provided that:
(a)The sum migration of all lanthanide substances does not exceed 0,05 mg/kg
(b)The lanthanide substance(s)
used are present in dissociated ionic form in the food or the food simulant.

15

Gadolinium

0.05

16

Lanthanum

0.05

17

Terbium

0.05

18

Antimony

0.04

Salts unallowed in accordance with Article 6(3)(a),the substances may only be present as an impurity.
*If hexavalent chromium is not used or formed during the entire production process, a limit for the total chromium of 3,6 mg/kg.

19

Arsenic

ND(DL=0.01)

20

Cadmium

ND(DL=0.002)

21

Chromium

ND(DL=0.01)*

22

Lead

ND(DL=0.01)

23

Mercury

ND(DL=0.01)

24

Nickel

0.02

Table 3 Reduced detection limit of primary aromatic amines

Regulations

Conditions

Requirements

(EU) No 10/2011 and its amendment regulations (as of (EU) 2019/1338)

Primary aromatic amines (PAAs) that are not listed in Table 1 of Annex I to the
Regulation.

The sum  of migration of PAAs is not detectable, detection limit is 0.01 mg/kg

Amended

PAAs are listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006, and are not listed in Table 1 of Annex I to the
Regulation.

The migration of PAAs is not detectable, the detection limit of each PAA is 0.002 mg/kg

PAAs are not listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006, and are not listed in Table 1 of Annex I to the
Regulation.

The sum of migration of PAAs is not exceed 0.01 mg/kg

2. Requirements of Information transmission

Amended the requirements of Annex IV, point 6 regarding the delivery of the declaration of conformity.

Table 4 Information transmission requirements

Regulations

Requirements

(EU) No 10/2011 and its amendment regulations (as of (EU) 2019/1338)

adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

Amended

Adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,
— that are subject to restrictions in Annex II, or
— for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0.00015 mg/kg food or food simulant.

3. Requirements of compliance test

Table 5 Test requirements for food processing and/or food producing equipment or appliance

Items

Content

Remark

Condition

Migration test is done by the whole equipment and under the worst foreseeable use conditions in the food, or when appropriate, in a food simulant

-

Condition of storage parts (containers, reservoirs, capsules, and pads)

in particular those parts that are used for storage, in some cases long term, such as containers, reservoirs, capsules, and pads. Those parts would need to be tested also separately to ensure they are safe for those storage conditions as well.

-

Judgment of compliance

When migration testing is done under the above conditions, and the transfer of from the equipment or appliance as a whole does not exceed the limits, the plastic parts or materials present in the equipment or appliance shall be considered to compliance.

Only the non-compliance is caused by plastic parts, the product can be determined to be non-compliant.

 If you have any needs or questions, please contact us at test@cirs-group.com.

Original link

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