As per the updates on the Regulation (EU) 2020/1245 in September 2020, the European Union introduced amendments in Regulation (EU) No. 10.2011 on plastic materials and articles intended to come into contact with food. The new regulation came into force on September 23, 2020.
The most significant changes are:
Union list of authorized substances (Annex I)
- Some amendments on the following substances:
- 1-3-phenylenediamine (CAS 108-45-2)
- Antimony trioxide (1309-64-4).
- Three entries are newly added.
Specific migration (Annex II)
- Heavy metals – Newly added 9 heavy metals on top of the existing 9 heavy metals (total 18 heavy metals) are required:
- Arsenic, Cadmium, Chromium, Europium, Gadolinium, Lanthanum, Lead, Mercury & Terbium.
- Primary aromatic amines (PAA) – the detection limits for PAA are amended:
- ≤ 0.002 mg/kg for each PAA listed in entry 43 Annex XVII to REACH Regulation No 1907/2006, and no migration limit is specified in Table 1 of Annex 1.
- ≤ 0.01 mg/kg for the sum of PAAs not listed in entry 43 of Annex XVII to REACH Regulation, and no migration limit is specified in Annex I.
Declaration of Compliance (Annex IV)
- Identification and quantity of substances in the intermediate materials are included.
Compliance Testing (Annex V)
- For repeated use materials and articles:
- The specific migration between subsequent tests does not increase (i.e. SM1 > SM2 > SM3).
- Stability of the material and articles also need to be verified. In cases of insufficient stability, compliance of the material shall NOT be established, even in cases where the specific limit is not exceeded in any of the three tests.
- For overall migration testing conditions:
- OM0 (new) – 30 minutes at 40°C for materials used only at cold or ambient temperatures for 30 minutes or less.
- OM4 – reflux condition is available as one of the options.
- Plastic materials and articles complying with Regulation 10/2011 as applicable before September 23, 2020, and which were first placed on the market before March 23, 2021, may continue to be placed on the market until September 23, 2022, and remain on the market until all stock has been sold
- New materials and articles that were manufactured after September 23, 2020, need to comply with the new regulation starting March 23, 2021.
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