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Food Contact Materials | Regulation Amendment


FCM: 12th Amendment to Regulation EU/10/2011


On January 11th, 2019 Regulation EU/2019/37 was published in the Official Journal of the European Union. It is the 12th amendment of Regulation EU/10/2011 on plastics for food contact and reflects the scientific findings already published by EFSA, resulting in several adjustments to annex I and annex III of the Regulation.

- Regarding Annex I, five changes are made to the positive list (Table 1), with adaptation of four previously-authorized substances (FCM 467, FCM 974, FCM 1066 and FCM 1068), and three new substances added to the list (FCM 1059, FCM 1067 and FCM 1069). Table 2 is also adjusted by the addition of group restriction N° 35 for the substances FCM 467, 744 and 1059.

- A new note (27) has been added regarding the verification of compliance (table 3) and for substance FCM 744, the detailed specifications in table 4 were adapted.

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Finally, an adjustment has also been made in point 4 of annex III, in which food simulants are assigned to different food categories for demonstrating compliance with the overall migration limit. The form of this list was already adjusted by regulation EU/2017/752 (table 3) and is now amended by adding a PH limit.



This Regulation has been entered into force on 31 January 2019. Plastic materials and articles complying with Regulation EU/10/2011 as applicable before the entry into force of this Regulation may be placed on the market until 31 January 2020 and may remain on the market until exhaustion of stocks.

The A.Hatzopoulos S.A. flexible packaging materials intended to come into contact with food fully comply with the EU/10/2011 regulation as amended to date.The relevant regulation is incorporated in our "Declaration of Compliance with Food Contact Legislation" document.

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Public Consultation on FCM legislation

European Commission announced the launch of the Online Public Consultation for the evaluation of food contact materials (FCM) legislation. The consultation, will run from 11th of February until the 6th of May and the target is to assess, to what extent the current EU legislative framework for food contact materials is fit for purpose and delivers as expected. It also aims to identify any “hidden” issues as a consequence of the current legislation. Finally, the evaluation will show whether the objectives and tools of the FCM legislation are still relevant and coherent.

The consultation is addressed a) to citizens – respondents should ideally not have any specialist knowledge on FCM, and b) to experts or those with prior knowledge of the FCM legislation and working in the field, including Member States’ authorities and those involved in the practical controls and enforcement.

To facilitate the process, the whole consultation is available in all languages of the EU.
https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-5809429/public-consultation_en