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 |
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. | |
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 | 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 | 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 | 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. |
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. |
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