SAFEGUARDS | Hardgoods, Food NO. 147/16

The European Union (EU) has recently amended the ‘Food Contact Plastics’ Regulation. This comprehensive amendment will be implemented in two phases starting September 14, 2016.

In May 2015, we [1] informed you that the World Trade Organisation (WTO) circulated a communication from the European Union (EU) announcing significant changes to Regulation (EU) 10/2011 on ‘Food Contact Plastics’.

On August 25, 2016, the EU published Regulation (EU) 2016/1416 [2] amending the ‘Food Contact Plastics’ Regulation.  This piece of comprehensive amendment contains a number of important changes to Regulation (EU) 10/2011. These include:

  1. Amending and expanding the list of authorised substances

  2. Assigning food simulants for migration tests for ‘fresh or chilled fruit’ and ‘fresh or chilled vegetables’ (Annex III, point 3, Table 2 ‘Food category specific assignment of food simulants’)

  3. Expanding the list of heavy metals to include aluminium for specific migration

  4. Providing a new definition for ‘hot-fill’

  5. Selecting simulants, and conditions for temperature and time

  6. Strengthening the specific migration of zinc

There are two effective dates:

  • September 14, 2016 for Regulation (EU) 2016/1416 (except for provisions on the specific migration limits for aluminium and zinc, and point 2 above) 

  • September 14, 2018 for provisions on the specific migration limits for aluminium and zinc and point 2 above 

According to the amendment, food contact plastics complying with Regulation (EU) 10/2011 as applicable before the entry into force of this Regulation may be placed on the market until September 14, 2017 and may remain on the market until exhaustion of stocks.

Highlights of major amendments and a comparison of the specific migration of heavy metals falling under point 1 to Annex II of Regulation (EU) 10/2011 are summarised in Tables 1 and 2, respectively.

Table 1: Regulation (EU) 2016/1416 amending Regulation (EU) 10/2011 on food contact plastics

Item Regulation (EU) 2016/1416 Highlights of Amendment to Regulation (EU) 10/2011

Article 3


New entry for point 19

Hot-fill means the filling of any article with a temperature of up to 100 °C at the time of filling, after which the food cools to no more than 50 °C within 60 minutes, or no more than 30 °C within 150 minutes


Annex I


Amendment to 6 substances, including new restrictions and specifications for 3 authorised substances (FCM substance Nos. 87, 391 and 974)
Inclusion of 10 completely new authorised substances

Annex 1, Point 3, Table 3

‘Verification of compliance’

Adding completely new entries 22 and 23

Annex III, Table 1

‘List of food simulants’

Specifying vegetable oils are such oils containing less than 1% unsaponifiable matter

Annex V, Table 2

‘Selection of test temperatures’

Addition of 2 temperature rules for testing above 175 °C. These are for applications with worst foreseeable contact temperatures (T) of:

175 °C < T ≤ 200 °C and T > 200 °C


Annex V, Chapter 2,

Section 2.1.4

‘Specific conditions for contact times more than 30 days at room temperature and below’

Completely new set of conditions

Annex V, Chapter 3

Table 3, Section 2.1.4

‘Standardised conditions for testing the overall migration’

Amending OM2 and OM3 by consideration of hot-fill conditions and formula for time

Amending OM6 by inclusion of simulant D1 (50% ethanol)


Annex V, Chapter 3

Section 3.2

‘Substitute overall migration tests for tests with simulant D2’

Migration tests to be performed using 95% ethanol and isooctane if it is not technically feasible to perform one or more of the tests for OM1 to OM6 in food simulant D2 (vegetable oil)
Effective date = September 14, 2016 (twentieth day following publication in the Official Journal of the EU)

Table 2: Annex II to Regulation (EU) 10/2011 relating to specific migration limits (in food or food simulant) for heavy metals in food contact plastics

Item Metal Regulation (EU) 2016/1416 amending Regulation (EU) 10/2011 Regulation (EU) 10/2011
1 Aluminium 1 mg/kg Not restricted
2 Barium 1 mg/kg 1 mg/kg
3 Cobalt 0.05 mg/kg 0.05 mg/kg
4 Copper 5 mg/kg 5 mg/kg
5 Iron 48 mg/kg 48 mg/kg
6 Lithium 0.6 mg/kg 0.6 mg/kg
7 Manganese 0.6 mg/kg 0.6 mg/kg
8 Zinc 5 mg/kg 25 mg/kg
Effective date September 14, 2018 May 2011

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. From overall migration test to expert advices on emerging regulations and compliance issues and documentation review, SGS is the partner to trust. Please do not hesitate to contact us for further information or visit our website.

For enquiries, please contact:

Hing Wo Tsang
t: +852 2774 7420

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