COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION of the legislation on Food Contact Materials - Regulation (EC) No 1935/2004
Date: 2022-06-09
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: application of EU law, consumer protection, food safety, foodstuff, foodstuffs legislation, health control, health risk, marketing, packaging product, storage of food

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   EUROPEAN COMMISSION  Brussels, 9.6.2022  SWD(2022) 164 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION  of the legislation on Food Contact Materials - Regulation (EC) No 1935/2004 {SEC(2022) 251 final} - {SWD(2022) 163 final}  
 
 
EVALUATION CONTEXT 

Food contact materials (FCMs) include food packaging, kitchenware and tableware as well as 
items  used  in  professional  food  manufacturing,  preparation,  storage  and  distribution.  Basic 
EU rules on safety as regards their chemical composition and transfer into food have been in 
place since 1976, with more specific EU rules being progressively added during the 1980s and 
1990s, most notably for plastic FCMs. Practical experience and exchanges with stakeholders 
over the years have raised several fundamental issues with the existing approach to regulating 
FCMs  at  EU  level.  This  exercise  formally  evaluated  the  EU  FCM  Regulation  (EC)  No 
1935/2004 (the ‘FCM Regulation’), including the approaches taken by the specific measures 
and  the  extent  to  which  it  has  achieved  its  primary  objectives  of  ensuring  a  high  level  of 
protection of human health and functioning of the EU market.  

The evidence to support the evaluation comes from Commission internal studies, an external 
supporting  study  and  targeted  public  consultations.  Available  data  was  limited  as  no 
monitoring  framework  exists  for  the  legislation  and  this,  together  with  a  lack  of  data  from 
stakeholders,  means  that  the  analysis  carried  out  is  subject  to  limitations.  Therefore,  some 
areas are supported by more robust evidence than others. 

KEY FINDINGS 

The evaluation shows that the FCM Regulation and its implementation are broadly effective 
in  terms  of  the  scope,  definitions  and  traceability  rules  to  achieve  the  set  objectives,  with 
some issues identified concerning effectiveness of labelling and communication to consumers. 
The  general  horizontal  requirements  of  the  FCM  Regulation  and  in  particular  those 
concerning  Good  Manufacturing  Practice  (GMP)  have  promoted  specific  guidance  from 
industry as well as Member States.  

The  evaluation  concludes  that  the  existing  approach  and  specific  rules  for  plastic  FCMs 
largely  ensure  the  safety  of  starting  substances  used  in  their  manufacture,  based  on  a 
transparent  EU  risk  assessment  and  authorisation  process.  The  current  legislation  provides 
legal  certainty  for  industry  with  supplementary  guidance  that  is  beneficial  to  stakeholders. 
Businesses are generally clear on their roles and responsibilities. Member States not only rely 
on specific rules  to  carry  out  official controls, but have also  adopted similar approaches for 
regulating other materials at national level. 

However, the EU rules for plastic FCMs are technically complex and resource intensive; for 
the Commission to manage, for EFSA to provide scientific risk assessment, for EU Member 
States to implement and enforce and for industry, in particular SMEs, to ensure compliance. 
Furthermore,  the  evaluation  has  identified  potential  weaknesses  in  the  current  approach  to 
regulating  plastic  FCMs.  These  concern  identification  and  measures  to  control  non-
intentionally added substances (NIAS), to ensure risk assessment and risk management is up 
to  date,  deficiencies  in  the  exchange  and  availability  of  compliance  documentation  in  the 
supply  chain  as  well  as  the  scope  of  the  mandatory  risk  assessment,  which  does  not 
sufficiently  address  vulnerable  populations  or  potential  exposure  to  combinations  of 
substances. Collectively, these issues highlight a need to  better ensure the safety of the final 
FCM article brought into contact with food consumed by all EU citizens.    

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In contrast to the specific complexities of the plastics Regulation, on its own, Article 3 of the 
FCM Regulation does not define the level of safety or quality expected for FCMs. Further, it 
does not state how safety should be achieved nor how it can be demonstrated. Many Member 
States  have  therefore  introduced  national  measures  for  non-plastic  FCMs.  However,  those 
measures  often  differ,  which  has  created  confusion  over  required  levels  of  safety  and  legal 
uncertainty for businesses, particularly SMEs, who may be faced, for example, with multiple 
testing regimes, increased costs and reduced access to the EU market. The application of the 
mutual recognition principle has so far not improved this situation. 

Member States are able to carry out inspections and controls only in a very limited capacity 
and  the  current  systems  of  official  controls  as  implemented  cannot  adequately  enforce  the 
requirements of the legislation. Inspections and official controls are hampered by the lack of 
specific  EU  requirements  on  which  to  base  controls,  lack  of  resources  and  prioritisation  of 
FCMs compared to other food safety issues, lack of validated methodology to test FCMs and 
difficulties in identifying FCM businesses. On the other hand, the specific EU rules on plastic 
FCMs are complex and require a high-level of expertise, which is rarely available in Member 
States. 

The evaluation indicates that the efficiency of the FCM legislation and its enforcement are not 
fully  satisfactory,  and  subsequent  benefits  to  consumers  are  still  below  their  potential. 
Nevertheless, health benefits are expected to exceed the costs. A qualitative analysis suggests 
that specific EU restrictions for certain substances have led to significant health benefits that 
may run into hundreds of millions of euros from the time the original intervention was made 
until  the  present.  Risk  assessments  that  make  better  use  of  all  available  information  on 
substances and extend beyond only plastic could lead to efficiency gains. 

Cost savings to industry and EU Member States derive mostly from EU measures on plastic 
FCMs  while  evidence  is  lacking  for  other  material  types.  Similarly,  trade  data  does  not 
provide  clear  evidence  of  enhanced  intra-EU  trade  due  to  the  adoption  of  the  FCM 
Regulation. Overall, costs to industry are estimated to be around 3% (EUR 3 billion) of the 
total  turnover,  composed  of  administrative  costs  (~1%)  and  compliance  costs  (~2%), 
including  applications  for  EU  authorisation  of  substances,  although  these  are  considered 
prohibitive  for  SMEs.  Costs  for  non-plastic  sectors  however  vary  significantly,  with  certain 
sectors,  including  paper  and  board,  facing  higher  costs.  The  likely  cause  of  this  is  multiple 
risk  assessment  and  testing  requirements  due  to  the  lack  of  specific  rules,  although  the 
relevance  of  other  factors  –  including  lost  market  opportunities  –  could  not  be  sufficiently 
quantified.  

Rules  on  FCMs  remain  very  relevant  with  citizens,  who  show  an  increased  interest  in  food 
safety  and  related  health  issues.  Businesses  continue  to  need  a  consistent  and  predictable 
regulatory platform on which to produce and trade their products across the EU with minimal 
burden.  However,  the  current  legislation  has  not  fully  met  the  needs  and  expectations  of 
businesses in this respect, in particular those producing many non-plastic FCMs and to some 
extent those producing final FCMs, particularly from multiple materials.  

Existing  rules  leave  some  room  for  new  and  evolving  science,  in  particular  establishing  a 
clear supportive role of the EU Reference Laboratory (EURL-FCM) in the implementation of 
the legislation and development of analytical  methodology  for tests  and analyses. Similarly, 

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the European Food Safety Authority (EFSA) has  also worked on identifying emerging risks 
and set up a network to enhance collaboration among national risk assessors.  

However,  the  evaluation  concluded  that  the  approach  to  regulating  plastic  FCMs,  which  is 
currently  geared  towards  risk  assessment  and  risk  management  of  well-established  polymer 
chemistry,  is  insufficient  to  address  new  and  potentially  more  innovative  FCMs.  This  is 
highlighted  by  challenges  faced  in  the  implementation  of  EU  legislation  on  active  and 
intelligent  FCMs  (AIM).  Ongoing  changes  in  the  design  of  materials  and  their  composition 
including  bio-based  and  biodegradable  materials  present  increasing  challenges  within  the 
constraints of the current approach. Other novel developments, such as those that incorporate 
nano-technology  and  chemical  recycling,  are  presently  insufficiently  addressed,  whereas 
future needs that cannot be met by current rules  are linked to growing consumer interests in 
re-use, recycling and environmental concerns.   

The evaluation indicates that the FCM Regulation is, in general, internally coherent with the 
main exception of Article 6, which has allowed EU Member States to introduce or maintain 
national  measures  in  the  absence  of  specific  EU  rules.  Often,  those  rules  differ  from  one 
Member State to another and have created a regulatory environment that is not fully aligned 
with the objectives of the legislation. For specific rules, there is a large gap between what is 
required  to  verify  compliance  (i.e.  with  specific  EU  rules  on  plastic  FCMs,  including 
hundreds of authorised substances with specific migration limits for each of them), and what 
is  enforceable  in  practice  with  available  resources,  also  considering  a  significant  lack  of 
validated analytical methodology. 

The  evaluation  finds  that  the  FCM  Regulation  is  coherent  with  other  EU  legislation 
concerning food safety and official controls. It is also complementary to other legislation on 
chemical  safety  of  substances,  including  the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemicals (REACH) Regulation, which does not consider specific risks from 
FCMs.  However, unlike  FCM legislation, the REACH Regulation  as  well as  sector specific 
legislation managing the risks from chemicals in consumer products such as cosmetics, places 
greater emphasis on the hazardous properties of a substance and this in turn is better reflected 
in those legislative processes.  

Gaps may  also sometimes exist with the REACH Regulation, as authorisation of substances 
under  the  FCM  Regulation  cannot  currently  take  into  account  restrictions  due  to 
environmental  concerns,  introduced  under  the  REACH  Regulation  or  the  Persistent  organic 
pollutants (POP) Regulation. Apart from the system in the US, regulation of FCMs in the EU 
is  relatively  coherent  with  that  in  third  countries,  which  in  general  have  followed  a  similar 
approach to that of the EU. 

There is considerable EU added-value from regulation of FCMs at EU level compared with 
national  level.  In particular, the EU specific rules  for plastic FCMs have positive effects  on 
effectiveness and efficiency. They provide equal protection of health for consumers across the 
EU as well as a level playing field for trade, where supply chains are set up to function across 
the  EU,  rather  than  being  country  specific.  Conversely,  non-plastic  sectors  struggle  with 
general, horizontal  EU requirements and multiple and  often differing national requirements, 
which have created uncertainty and barriers to trade.  

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Overall, the FCM Regulation functions, to a certain extent, as expected and partly fulfils its 
objectives,  in  particular  for  plastic  FCMs  for  which  specific  EU  rules  apply.  The  main 
deficiencies  relate  to  lack  of  specific  rules  for  FCMs  besides  plastic,  the  inability  to 
demonstrate  compliance,  unavailability  of  information  in  the  supply  chain,  challenges  in 
enforcement and lack of prioritisation of the most hazardous substances. The current system 
in  general  provides  inadequate  support  to  SMEs.  Finally,  the  current  legislation  and 
approaches  are  also  largely  incompatible  with  current  trends  in  the  switch  from  materials 
synthesised from traditional chemistry such as polymers to more novel or natural, sustainable 
alternatives. 

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