RECYCLED PLASTICS IN FOOD CONTACT PACKAGING EVALUATION PROCEDURE, RISK ASSESSMENT, NOTIFICATION

Transcription

1 RECYCLED PLASTICS IN FOOD CONTACT PACKAGING EVALUATION PROCEDURE, RISK ASSESSMENT, NOTIFICATION Bernard Hegarty, 26 November 2012

2 Contents Why recycled plastics? EU legislation on the topic EFSA evaluation Commission authorisation

3 Why recycled plastics?

4 Recycling plastics Ireland produced over 1,000,000 tonnes of packaging waste (including food packaging) in 2006 EPA National waste report 2006 UK households use 525,300 tonnes or approximately 13 billion plastic bottles each year 4

5 The recycling mandate Green agenda Directive 94/62/EC on packaging and packaging waste Plastic recycling rates are far too low across Europe with an average of just 24 %.... Plastic must be responsibly managed and produced, using the life-cycle assessment methodology. It must be responsibly used and recycled from cradle to cradle without escaping a closed loop of responsible treatment at its end of life phase. Janez Potočnik, European Commissioner for Environment, Sept. 2012

6 Increase in recovery of packaging

7 The problems How to prevent contamination of food from a packaging made from rubbish? How to set a safe level for unknown contaminants? Different views in different MS different national legislation 7

8 EU legislation

9 EU Harmonised laws Framework Regulation (EC) No 1935/2004 General requirements for all FCM + Mandate for specific measures Ceramics GMP Regulation (EC) No 2023/2006 SPECIFIC MEASURES Materials Regenerated cellulose film Plastics Recycled plastics Active and intelligent Materials Substances Nitrosamines BADGE, BFDGE & NOGE

10 Regulation (EC) No 282/2008 on recycled plastics Regulation applies to mechanical recycling of plastics Requires the individual authorisation of recycling process by Commission, after a toxicological evaluation by EFSA. Critical points in the recycling process: the sourcing of the raw material (food contact plastic); the capacity of process to reduce contamination. Recycling processes must have an adequate quality assurance system, audited by Member States. Requires a declaration of compliance. Recycled plastics from outside EU: can only be used if the recycling process is authorised by Commission and the premises notified to the Commission. 10

11 Plastic multi-layer materials and articles If any layer is recycled plastic, then Reg. 282/2008 applies However, if a plastic functional barrier* is present, between the recycled plastic and food: Reg. 282/2008 does not apply Food The recycled plastic does not have to come from an authorised process * Functional barrier as defined in Regulation 10/2011.

12 Voluntary labelling Article 11 of Reg. 282/2008 Optional to declare the presence/content of recycled plastic If doing so, then the rules of ISO 14021:1999 apply

13 Framework Regulation (1935/2004)

14 FRAMEWORK REGULATION (1935/2004) General requirements and definitions

15 FRAMEWORK REGULATION (1935/2004) General requirements (Article 3): food safety Food contact materials Must not endanger human health Must not cause unacceptable change in food composition or organoleptic characteristics (taint) Must not mislead the consumer (labelling, advertisement)

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17 Specific Requirements for substances Substances used in the manufacture of plastics are subject to: Specific Migration Limit (SML) Overall Migration Limit (OML) Particular restrictions and specifications set out in Annex 1 (Table 1 of Point 1) Substances in nano form have to be authorised separately

18 Specific Migration Limit (Art. 11) Specific migration limits set out in Annex I (Annex II sets out SMLs for metals) SML expressed as mg of substance per kg food If no SML or other restriction in Annex I the generic SML of 60mg/kg applies Dual use additives should comply with lower legislative limit Use in FCM shall not result in a technological effect in food

19 Overall Migration Limit (Art. 12) OML established at 10mg/dm 2 Assume 1kg of food consumed per day contained in cubic packaging, if OML is 10mg/dm 2, this is equivalent to 60mg/kg If surface to volume ratio higher (small packaging) then migration will be higher Plastic materials and articles intended to be brought into contact with food for infants and young children based on level in food: OML = 60mg/kg

20 Assessment of recycled plastics

21 Risk Assessment for processes To date, EFSA only evaluates processes for recycling plastics (post-consumer waste) into food-grade plastics All plastics recycling processes require authorisation EFSA Guidance to applicants (2008) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

22 EU FCM authorisation process New substance or process developed Submitted to a Member State Positive List of authorised substances /processes Submitted to EFSA for evaluation EFSA evaluation is positive? EC authorises its use, in a specific law

23 FRAMEWORK REGULATION (1935/2004) Authorisation procedure Application submitted to Member States Assessed by EFSA within specific timescale Authorisations are generic Authorisations can be modified or suspended Business operators using a substance or process have to inform the Commission on new scientific data/information

24 24 Global Food Contact Legislation, June 2009

25 EFSA checklist

26 General recycling steps

27 Special considerations Unknown contaminants: how to assess risk? General challenge tests: ability of the process to remove typical contaminants Surrogate contaminants: Toluene, chlorobenzene, chloroform, lindane, limonene, phenylcyclohexane, benzophenone,... Consideration of source (closed loop, kerbside collection, etc)

28 Potential contamination sources In the case of recycled PET: 1. Misuse of the PET container 2. Non-FCM grade PET 3. Other materials, e.g. inks, glues, labels 4. Chemicals used in the recycling process 5. Degradation products of the plastic/additives 6. Food components or degradation products

29 Schematic of a recycling process for PET

30 The risk evaluation

31 GMP Regulation (EC) 2023/2006 Quality assurance system Selection of starting materials (chemicals) to ensure the compliance of the final article with Article 3 of 1935/2004 (i.e. not endanger health, not mislead etc) Operations design to ensure the compliance of the final articles as regards contamination, reaction and degradation products Quality control system Establish testing frequency of the final product to ensure compliance Documentation covering manufacturing process Specifications for starting materials and end product, plus test results However there are specific rules for recycled plastics

32 Key dates for recycled plastics Regulation 282/2008 came into force: 17 April 2008 EFSA Guidelines published: 1 July 2008 Deadline for submission of initial applications: 1 January 2010 EFSA opinions on all applications: No deadline; assume all will be issued by January 2014? Commission issue draft Decisions granting/refusing authorisations: 6 months later (July 2014?) Decisions adopted (become law), and Articles 3, 9, 10 & 12 apply : December 2014? RP processes, currently on the market, refused authorisation: Trade/use of RP allowed till 6 months later (June 2015?) Trade/use of RP materials & articles: till stocks exhausted

33 Declaration of Compliance N.B. MS rules may require DoC even if no EU requirement

34 FRAMEWORK REGULATION (1935/2004) Declaration of compliance (DoC) DoC requirements exist for: Plastics Recycled plastics Both apply to recycled plastics, with additional requirements for 1. Materials and articles made from recycled plastic; 2. Recycled plastic

35 Recycled plastics (Reg 282/2008) Recycling processes will be authorised by Commission after evaluation by EFSA 63 valid applications received by deadline (91 in total) A condition of the authorisation is that that processers must comply with the instructions specified by the process-owner FVO will audit TC recyclers August-October 2012: EFSA adopted 5 opinions covering 15 PET recycling processes, grouped according to similarities in their technologies

36 Summary Recycling of plastic food contact materials to make food-grade material is possible A detailed set of legislation applies in the EU to control the sector, based on authorised recycling processes The evaluation by EFSA of recycling processes is challenging and rigorous The result: safer, greener plastic food packaging