COMMISSION STAFF WORKING DOCUMENT 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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 9.6.2022  SWD(2022) 163 final  COMMISSION STAFF WORKING DOCUMENT  EVALUATION  of the legislation on food contact materials - Regulation (EC) No 1935/2004 {SEC(2022) 251 final} - {SWD(2022) 164 final}  
 
 
Table of contents 

1. 
1.1. 

INTRODUCTION ................................................................................................................ 6 
7 

Purpose and scope of the evaluation 

2.  BACKGROUND TO THE INTERVENTION ................................................................... 7 
8 
2.1.  Description of the intervention and its objectives 

2.2.  Baseline and other points of comparison 

10 

3. 
3.1. 

IMPLEMENTATION/STATE OF PLAY ...................................................................... 11 
11 

Establishment of authorised substances 

3.2.  Other EU FCM legislation 

3.3.  Documentation requirements 

3.4.  National legislation 

13 

14 

15 

4.  METHOD ........................................................................................................................... 15 
15 
4.1. 

Short description of methodology 

4.2. 

Limitations and robustness of findings 

16 

5.  ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ....................... 17 
17 
5.1. 

Effectiveness 

5.2. 

Efficiency 

5.3.  Relevance 

5.4.  Coherence 

5.5. 

EU added value 

29 

42 

48 

55 

6.  CONCLUSIONS ................................................................................................................. 57 

ANNEX 1: PROCEDURAL INFORMATION ........................................................................ 62 

ANNEX 2: STAKEHOLDER CONSULTATION ................................................................... 64 

ANNEX 3: METHODS AND ANALYTICAL MODELS ....................................................... 75 

ANNEX 4: OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE 
EVALUATION ........................................................................................................................... 78 

ANNEX 5: SUPPORTING TABLES AND DIAGRAMS....................................................... 80 

ANNEX 6: CASE EXAMPLES .................................................................................................. 90 

ANNEX 7: OVERVIEW OF MAIN SPECIFIC MEASURES ON FCMS THAT ARE 
CURRENTLY APPLICABLE AT EU LEVEL AND THEIR IMPLEMENTATION .......... 94 

ANNEX 8: INTERVENTION LOGIC ...................................................................................... 97 

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Glossary 

Acronym 

Meaning or definition 

ADC 

AIM 

BADGE, 
BFDGE and 
NOGE 

BfR 

BPA 

CEN 

CMR 

CoE 

DoC 

Azodicarbonamide. Used as a foaming agent in plastic gaskets that are used 
to seal metal lids to glass packaging. 

Active and intelligent food contact materials (FCMs). Active FCMs extend 
the shelf-life or maintain or improve the condition of packaged food; they 
are designed to  deliberately incorporate components  that would release  or 
absorb  substances  into  or  from  the  packaged  food  or  the  environment 
surrounding  the  food.  Intelligent  materials  and  articles  monitor  the 
condition of packaged food or the environment surrounding the food. 

Bisphenol  A  diglycidyl  ether  (BADGE),  bisphenol  F  diglycidyl  ether 
the 
(BFDGE)  and  novolac  glycidyl  ethers 
polimerisation process of epoxy resin out of bisphenol A (BPA), bisphenol 
F (BPF) or novolac and monomers that are not fully chemically bound may 
migrate into food. 

(NOGE) 

result 

from 

Bundesinstitut  für  Risikobewertung  (German  Federal  Institute  for  Risk 
Assessment). 

Bisphenol A. A monomer used in the manufacture of polycarbonate plastic 
and epoxy coatings. 

European  Committee  for  Standardization  is  an  association  that  brings 
together the National Standardization Bodies of 34 European countries. 

Carcinogenic, mutagenic and reprotoxic chemicals. They make up the first 
and  most  toxic  category  of  the  toxicity  classes  into  which  hazardous 
chemicals can be subdivided, according to EU legislation. 

Council of Europe. 

Declaration of compliance. This is a written declaration stating that FCMs 
comply  with  the  specific  rules  applicable  to  them  as  per  Article  16  of 
Regulation (EC) No 1935/2004. 

EFSA 

The European Food Safety Authority  is responsible for risk assessment in 
the area of food safety. 

EURL-FCM 

European Union Reference Laboratory. 

FCMs 

Food contact materials are all materials and articles which are intended to 
come  into  contact  with  food  including  those  which  are  already  in  contact 
with food and those which can reasonably be expected to come into contact 

2 

 
 
with  food  or  transfer  their  constituents  into  food  under  normal  or 
foreseeable  conditions  of  use  as  per  Article  1(2)  of  Regulation  (EC)  No 
1935/2004. 

Full-time equivalent. It is a unit to measure employed persons in a way that 
makes them comparable although they may a different number of hours per 
week. The unit is obtained by comparing an employee's average number of 
hours worked to the average number of hours of a full-time worker.  

Good Manufacturing Practice. 

The  International  Organisation  for  Standardisation  is  an  international 
standard-setting  body  composed  of  representatives  from  various  national 
standards organisations. It promotes worldwide proprietary, industrial, and 
commercial standards. 

The Commission’s Joint Research Centre. 

Limit of Quantification. It is the smallest amount of a substance that can be 
measured  with  stated  and  acceptable  imprecision  and  inaccuracy  (e.g.  the 
smallest  concentration  of  a  chemical  that  can  be  measured  with  sufficient 
precision in a millilitre of water). 

Non-intentionally added substances. These are impurities in the substances 
used  to  manufacture  FCMs  or  reaction  intermediates  formed  during  the 
production  process  or 
through 
decomposition. 

reaction  products  or 

impurities 

Non-governmental  organisation.  NGOs  are  usually  non-profit  and 
independent of governments (though often funded by governments) that are 
active  in  humanitarian,  educational,  health  care,  social,  human  rights,  or 
environmental causes. 

National  Reference  Laboratory.  It  is  required  to  implement  quality 
assurance  and  is  often  the  main  laboratory  where  official  controls  are 
undertaken. 

Overall Migration Limit. This applies to the sum of all substances that can 
migrate from the FCM into food (or food simulant). The OML is a measure 
for the inertness of the material. 

Polyethylene 
thermoplastic polymer. 

terephthalate 

(PET  or  PETE) 

is  a  general-purpose 

FTE 

GMP 

ISO 

JRC 

LOQ 

NIAS 

NGO 

NRL 

OML 

PET 

PVC 

Polyvinyl chloride, a synthetic plastic polymer. 

RASFF 

Rapid  Alert  System  for  Food  and  Feed.  A  key  tool  to  ensure  the  flow  of 
information  to  enable  swift  reactions  when  risks  to  public  health  are 
detected in the food chain. 

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RCF 

REACH 

Regenerated  cellulose  film.  Materials  manufactured  by  the  conversion  of 
natural  cellulose  to  a  soluble  cellulosic  derivative  and  subsequent 
regeneration,  typically  forming  either  a  fibre  (e.g.,  rayon)  or  a  film  (e.g., 
cellophane). 

REACH stands for Registration, Evaluation, Authorisation and Restriction 
of Chemicals, which is provided for by Regulation (EC) No 1907/2006 of 
the European Parliament and of the Council of 18 December 2006.  

SCF 

Scientific Committee for Food. The Committee carried out risk assessment 
work on FCMs prior to the establishment of EFSA. 

SC-PAFF 

Standing Committee on Plants, Animals, Food and Feed. 

SD 

SME 

SMC 

SML 

TDI 

Supporting Documentation. It must demonstrate that FCMs, products from 
intermediate  stages  of  their  manufacturing  as  well  as  the  substances 
intended for the manufacturing of those materials and articles comply with 
the  requirements  of  legislation.  It  contains  the  conditions  and  results  of 
testing,  calculations  including  modelling,  other  analysis,  and  evidence  on 
the safety or reasoning demonstrating compliance. 

Small,  medium  and  micro-sized  enterprise  defined  by  staff  headcount, 
turnover or balance sheet total1. 

Semicarbazide is formed from the breakdown of azodicarbonamide.  

Specific Migration Limit. The amount of substance allowed to migrate into 
food from the FCM. 

Tolerable daily intake. A TDI is an estimate of the amount of a substance 
in  air,  food  or  drinking  water  that  can  be  taken  in  daily  over  a  lifetime 
without  appreciable  health  risk.  TDIs  are  often  calculated  based  on 
laboratory toxicity data to which uncertainty factors are applied. 

VCM 

Vinyl chloride monomer, used to manufacture polyvinyl chloride (PVC). 

1 https://ec.europa.eu/growth/smes/sme-definition_en  

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1.  INTRODUCTION 
Food contact materials (FCMs) are all materials and articles which are intended to come into 
contact  with  food,  including  those  that  are  already  in  contact  with  food  and  those  that  can 
reasonably be expected to come into contact with food or transfer their constituents into food 
under  normal  or  foreseeable  conditions  of  use  –  in  accordance  with  the  principal  basic  act 
Regulation (EC) No. 1935/20042 (hereafter also referred to as the ‘FCM Regulation’). FCMs 
include food packaging, kitchenware and tableware as well as items used in professional food 
manufacturing, preparation, storage and distribution.  

FCMs are manufactured using a wide variety of different materials, including plastics, paper 
and board, metals, rubber, ceramic and glass; natural materials such as wood and other plant 
based materials, as well as components used widely in packaging such as coatings, adhesives 
and  inks.  FCMs  contribute  directly  to  the  safe  production,  processing,  transport,  sale  and 
ultimately consumption of all foodstuffs placed on the market in the EU.  

No FCM is completely inert and substances are present in final articles, including those used 
in their manufacture, those formed from chemical reactions during their manufacture or those 
present  as  breakdown  products  and  impurities.  They  may  transfer  to  food,  resulting  in 
exposure  of  humans  consuming  that  food.  Therefore,  since  1976  EU  legislation  has  placed 
basic  requirements  on  businesses  concerning  the  safety  of  FCMs  and  substances  migrating 
from  them  with  the  aim  of  securing  a  high  level  of  protection  of  human  health  and  the 
interests of consumers, whilst ensuring the effective functioning of the internal market.  

The  FCM  Regulation  sets  out  the  modalities  for  the  authorisation  of  substances  used  to 
manufacture FCMs, which must be followed in cases where a specific measure establishes a 
list of authorised substances for the manufacture of certain FCMs. Further specific measures 
may then include compositional and testing requirements and restrictions such as the amount 
of  substance  allowed  to  transfer  into  the  food.  The  FCM  Regulation  also  provides  rules  on 
labelling,  compliance  documentation,  traceability  as  well  as  inspection  and  controls.  It  is 
complemented by a Regulation on requirements for good manufacturing practices (GMP)3. 

The  current  main  EU-specific  measure  concerns  plastic  FCMs4,  which  includes  a  list  of 
authorised  substances  that  may  be  used  in  their  manufacture.  A  number  of  other  specific 
measures also exist, on ceramics, recycled plastics, active and intelligent materials (AIM) and 
certain  specific  substances5  (see  also  annex  7).  In  the  absence  of  EU-specific  measures, 
Member States may maintain or adopt their own national provisions on FCMs as per Article 6 
of  Regulation  (EC)  No.  1935/2004;  such  national  legislation  is  in  place  in  many  Member 
States.  

The  current  FCM  Regulation  does  not  contain  requirements  addressing  hygiene, 
environmental concerns or waste management. 

2 http://data.europa.eu/eli/reg/2004/1935/oj  
3 http://data.europa.eu/eli/reg/2006/2023/oj  
4 http://data.europa.eu/eli/reg/2011/10/oj 
5 https://ec.europa.eu/food/food/chemical-safety/food-contact-materials/legislation_en  

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1.1. Purpose and scope of the evaluation 

Although  the  EU  legislation  on  FCMs  was  never  formally  evaluated  prior  to  this  exercise, 
informal monitoring of the legislation has taken  place over many  years  by  way of  feedback 
and dialogue on its practical management and implementation, in working group meetings as 
well as correspondence with EU Member States experts6, with industry associations and other 
stakeholders.  This  dialogue  together  with  increasing  experience  with  the  functioning  of  the 
legislation  in  practice  raised  several  fundamental  issues  with  the  existing  approach  to 
regulating  FCMs  at  EU  level.  These  encompass  the  risk  assessment  and  risk  management 
processes,  in  particular  the  authorisation  of  starting  substances;  the  compliance  of  final 
articles, information  flow in  the supply chain, enforcement,  as well as coherence with  other 
legislation.  

Furthermore, the lack of EU-specific rules beyond mainly plastic FCMs is considered by most 
stakeholders  to  negatively  impact  the  functioning  of  the  internal  market  and  possibly,  the 
safety of FCMs.  In 2017, the Commission’s Joint  Research Centre (JRC) published a study 
(JRC ‘baseline’ study)7 setting out detailed information on the different  FCM supply chains 
and  national  measures  in  Member  States.  It  analysed  the  effectiveness  of  such  measures  on 
the safety of FCMs and coherence as well as the possible burden of national instruments on 
Member States and businesses.  

This evaluation assesses the EU FCM legislation in all EU Member States at the time of its 
undertaking  (i.e.  including  the  UK)  as  well  as  its  application  in  EEA  countries  and 
Switzerland.  This  includes  the  main  elements  introduced  in  the  first  Council  Directive 
76/893/EEC8  and  maintained  in  the  current  FCM  Regulation  (EC)  No  1935/2004,  such  as 
basic requirements on safety. It also includes elements that were introduced in 1976, such as 
the  role  of  the  European  Food  Safety  Authority  (EFSA)  and  the  approaches  taken  by  the 
specific measures to regulating FCMs, including assessment and authorisation of substances – 
primarily in plastic FCMs.   

As Member States can maintain or introduce national measures in the absence of EU-specific 
rules  according  to  the  FCM  Regulation,  the  evaluation  also  considers  the  impact  of  the 
presence of national measures.  

2.  BACKGROUND TO THE INTERVENTION 
The size of the European FCM market is estimated to be around EUR 100 billion per annum7, 
with  more  than  half  of  this  value  coming  from  the  plastic  as  well  as  paper  and  board 
industries.  The  glass,  metal  and  machinery  sectors  are  also  considerable  in  value,  with  a 
significant  number  of  businesses  producing  and  transforming  other  materials  critical  to  the 
manufacture of FCMs, including silicones, rubbers, wood, ceramics, coatings, adhesives and 
inks. Table 2 in annex 5 summarises the distribution of different sized businesses and annual 
revenue  for  several  sectors.  Figure  6,  annex  5  provides  a  generalised  overview  of  the  FCM 
supply chain.  

6 https://ec.europa.eu/food/food/chemical-safety/food-contact-materials/fcm-document-library_en  
7 https://publications.jrc.ec.europa.eu/repository/handle/JRC104198 
8 http://data.europa.eu/eli/dir/1976/893/oj  

6 

 
                                                 
 
Imports make up a considerable portion of the EU market. Although the value of all imports 
including  raw  materials  is  difficult  to  accurately  quantify,  as  the  Combined  Nomenclature 
(CN) codes for imports  are not sufficiently detailed,  they play  a significant  role in  bringing 
kitchenware and tableware into the EU, with an estimated value of around EUR 340 million9. 

2.1.  Description of the intervention and its objectives  
The EU started to legislate FCMs in 1976 with Council Directive 76/893/EEC in recognition 
of  the  potential  risks  to  human  health  from  FCMs  and  potential  problems  concerning  the 
functioning of the internal market. Since then the legislation has been revised twice; once in 
1989 by way of Directive 89/109/EEC10 and again in 2004 when the current FCM Regulation 
was adopted.  

The general objectives pursued by the legislation on FCMs since 1976 are twofold:  

1.  Provide  the  basis  for  securing  a  high  level  of  protection  of  human  health  and  the 

interests of consumers;  

2.  Ensure the functioning of the internal market.  

To  support  these  general  objectives,  the  regulation  contains  a  principle  legal  requirement 
(Article  3)  which  states  that  “materials  and  articles  [FCMs]  must  be  manufactured  in 
compliance  with  good  manufacturing  practice,  so  that,  under  their  normal  or  foreseeable 
conditions  of  use,  they  do  not  transfer  their  constituents  to  foodstuffs  in  quantities  which 
could endanger human health or bring about an unacceptable change in the composition of 
the foodstuffs or a deterioration in the organoleptic characteristics thereof.” 

The specific objectives aim to ensure the following: 

1.  FCMs  are  manufactured  to  a  high-quality  standard  by  requiring  the  application  of 
GMP  for  all  materials  and  articles  and  specific  measures  on  information  flow  in  the 
FCM  supply  chain  through  a  declaration  of  compliance  (DoC)  and  supporting 
documentation; 

2.  the interests of consumers are addressed, concerning information 
on the correct and safe use through labelling requirements such 
as the wine glass and fork symbol (see right) and prohibition of 
misleading labelling, advertisement or presentation;  

3.  enforceability including the removal of non-compliant products 
from  the  market  through  official  control  and  traceability 
throughout the FCM supply chain; 

4.  transparency  of 

the  safety  assessment  procedures  of  FCMs  and 

to  ensure 

accountability and dependency of the authorisation processes; 

5.  technological  progress  is  taken  into  account  by  setting  out  rules  for  materials  that 

intentionally change food in accordance with the food law. 

9 Wood; table and kitchenware (HS Code 441900) imports into EU in 2019. World Integrated Trade Solution. 
10 http://data.europa.eu/eli/dir/1989/109/oj 

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Annex 8 provides  the  intervention logic  of the original needs, objectives of the intervention 
and actions taken, as well as the outcome and anticipated impacts with a particular focus on 
the points above introduced in 2004. 

The EU legislation on FCMs fits into the wider EU policy on food, chemicals and consumer 
protection.  In  particular,  following  the  farm  to  fork  approach  governing  the  General  Food 
Law, it complements Regulation (EC) No 178/2002 (the General Food Law)11 concerning the 
safety of foodstuffs, which does not cover transfer from FCMs into food. Official controls on 
FCMs are within the scope of the food and feed control Regulation (EU) 2017/62512.  
Other relevant legislation concerning the risk management of chemicals and the protection of 
citizens include those related to drinking water13, medical devices14, toys15, cosmetics16 and the 
general product safety legislation17, in which substances found in FCMs may also be regulated 
(such as phthalates), although there is no direct link between the legislation. 

Substances  used  in  the  manufacture  of  FCMs  are  subject  to  registration  requirements  under 
the main chemicals Regulation (EC) No 1907/200618 concerning the Registration, Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH),  depending  on  the  tonnage  used. 
Additionally, where risks may be identified from substances to the environment as opposed to 
human  health,  authorisation  of  certain  substances,  including  those  used  in  FCMs,  may  be 
required.  As  an  alternative  risk  management  approach,  a  limited  number  of  substances  are 
subject  to  restrictions  set  out  in  Annex  XVII  to  that  Regulation,  including  their  presence  in 
FCMs. 

Of  more  recent  relevance  are  interactions  with  major  Commission  policies  on  the  circular 
economy  (recycling) and the plastic strategy (e.g. the single use plastics Directive19), which 
bans the use of certain single use FCMs such as plastic straws. 

11 http://data.europa.eu/eli/reg/2002/178/oj  
12 https://eur-lex.europa.eu/eli/reg/2017/625/oj  
13 https://eur-lex.europa.eu/eli/dir/2020/2184/oj 
14 http://data.europa.eu/eli/reg/2017/745/oj 
15 http://data.europa.eu/eli/dir/2009/48/oj 
16 http://data.europa.eu/eli/reg/2009/1223/2019-08-13 
17 http://data.europa.eu/eli/dir/2001/95/oj 
18 http://data.europa.eu/eli/reg/2006/1907/2020-08-24  
19 http://data.europa.eu/eli/dir/2019/904/oj  

8 

 
 
 
                                                 
 
Figure 1: Relationship between the FCM legislation and other legislation on chemicals, 
food and consumer products 

2.2.  Baseline and other points of comparison  
In general, the evaluation uses the situation before the introduction of EU rules as a point of 
comparison.  Although  some  individual  rules  existed  in  Member  States  as  far  back  as  1912, 
work  on  FCMs  started  to  develop  in  the  1950s  and  1960s  as  the  use  of  more  synthetic 
materials began to grow in importance. Some countries such as Germany and the Netherlands 
introduced  specific  lists  of  positive  authorised  substances,  including  limits  on  those 
substances per polymer type, taking account of the specific technological properties of each 
material. A more toxicological approach prevailed in several other Member States including 
Italy, France, Belgium and Luxembourg. 

In the late 1960s, the Council of Europe (CoE) took steps to design a harmonised approach 
addressing  FCMs  by  designing  a  draft  Resolution  for  plastic  FCMs.  Despite  these  efforts, 
many differences amongst the then Member States remained unresolved. 

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For  assessing  the  effectiveness  of  specific  EU  measures,  primarily  plastic  FCMs,  a 
comparison has been made with the situation for sectors that to date do not have specific EU 
measures (sometimes referred to as “non-harmonised”) areas. Where possible, a comparison 
is made with other EU measures regulating chemicals (see section 4.1), as well as legislation 
in third countries. 

3.  IMPLEMENTATION/STATE OF PLAY 
The  FCM  Regulation  is  directly  applicable  to  all  businesses  involved  in  the  manufacture, 
import,  processing  and  distribution  of  FCMs  on  the  EU  market  including  food  businesses 
selling packaged food. In addition to laying down its scope and providing certain definitions, 
it sets out basic requirements on safety and changes to food, as described in Article 3 of the 
FCM  Regulation,  labelling  to  ensure  the  safe  use  of  FCMs  by  consumers  (Article  15)  and 
traceability (Article 17) in the supply chain.  

All FCM businesses manufacturing FCMs in the EU must comply with rules on GMP, which 
aim  to  support  compliance  and  conformity  of  FCMs  throughout  the  entirety  of  the 
manufacturing processes rather than simply at the end. 

The Commission is empowered to adopt specific measures for the 17 material types presently 
listed  in  Annex  I  of  the  FCM  Regulation,  normally  in  accordance  with  the  Regulatory 
Procedure  with  Scrutiny  (“PRAC”),  following  consultation  with  the  toxicological  safety 
section of the Standing Committee on Plants, Animals, Food and Feed (SC-PAFF).  

The  main  specific  EU  measure  regulates  the  composition  of  plastic  FCMs  and  features  a 
Union list of substances authorised for use in the manufacture of plastic FCMs. Restrictions 
for these substances used in FCMs are also often introduced to ensure safety, including limits 
on the content in the final material or for their transfer into food, commonly known as specific 
migration limits (SMLs). 

3.1.  Establishment of authorised substances 
Building  on  work  already  done  by  Member  States,  early  scientific  risk  assessments  at  EU 
level to inform on the authorisation of substances was undertaken by the Scientific Committee 
for  Food  (SCF),  an  advisory  body  set  up  by  the  Commission  in  1974.  This  was  initially 
achieved  for  regenerated  cellulose  film  (RCF)  in  198320,  which  currently  exists  as 
Commission  Directive  2007/42/EC21  and  eventually  by  the  start  of  the  1990s,  a  first  list  of 
monomers and other starting substances (‘building blocks’ for plastic), authorised for use in 
the manufacture of plastic FCMs, was established. 

Since the introduction of the FCM Regulation, the functions of risk manager and risk assessor 
have been separated to ensure transparency of the safety assessment procedures of FCMs and 
to  ensure  accountability  and  dependency  of  the  authorisation  processes.  Consequently,  the 
scientific risk assessment work has been conducted by EFSA which replaced the former SCF. 
The current FCM Regulation lays down specific procedures for the application process for the 

20 http://data.europa.eu/eli/dir/1983/229/oj 
21 http://data.europa.eu/eli/dir/2007/42/oj 

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assessment  and  authorisation  of  a  substance  subject  to  authorisation,  including  specific 
provisions on public access to applications for authorisation, supplementary information from 
applicants and opinions from EFSA. 

In order to have a substance assessed, a business operator must compile a dossier of scientific 
information in accordance with EFSA guidelines22, published in accordance with Article 9(2) 
of  the  FCM  Regulation.  The  dossier  is  sent  to  EFSA  via  any  Member  State  competent 
authority  and  should  be  assessed  by  EFSA  within  six  months,  subject  to  the  need  for 
supplementary information. EFSA then publishes an opinion indicating whether the substance 
is safe for its intended use, the conditions under which it can be used as well as restrictions of 
use for the evaluated substance and/or the [plastic] FCM in which it is used. 

Taking into account the opinion of EFSA, the Commission may authorise the substance and 
set  out  any  necessary  restrictions  for  its  use,  including  an  SML.  Thereafter,  any  business 
operator  may  use  the  authorised  substance  in  the  [plastic]  FCM  and  must  comply  with  any 
condition or restriction attached to such authorisation. Furthermore, business operators must 
inform the Commission of any new scientific or technical information, which might affect the 
safety assessment of the authorised substance in relation to human health. If necessary, EFSA 
then reviews the assessment. 

Commission  Regulation  (EU)  No  10/2011  on  plastic  FCMs  (“the  plastics  Regulation”), 
includes a Union list of about 900 starting substances and additives authorised for use in the 
manufacture of plastic FCMs, including specifications and restrictions on their use. No other 
substances  may  be  used,  unless  there  is  a  derogation,  until  they  have  been  assessed  and 
authorised.  The  plastics  Regulation  consolidated  and  simplified  the  previous  two  decades’ 
worth  of  EU  legislation  on  plastic  FCMs,  and  adapted  to  technological  developments  by 
including  rules  for  plastics  used  in  combination  with  other  materials  in  so  called  multi-
material  multi-layers,  such  as  adhesives  or  inks,  acknowledging  the  shift  in  FCMs  on  the 
market,  and  rules  on  documentation  that  must  accompany  the  FCMs  and  how  to  verify 
compliance with the rules (e.g. testing). 

The  Regulation  also  provides  certain  derogations,  for  example  for  substances  that  catalyse 
reactions during the manufacturing process. Such ‘aids to polymerisation’ are used in minute 
amounts and are not intended to remain in the final polymer. They are therefore subject to a 
risk  assessment  by  the  business  operator,  rather  than  requiring  a  full  application  and 
assessment  by  EFSA  and  authorisation  by  the  Commission.  Substances  from  chemical 
reactions  or  degradation  may  also  be  formed  during  the  production  of  plastics  –  otherwise 
known as non-intentionally added substances (NIAS). Although they are relevant for the risk 
assessment,  it  is  not  practically  possible  to  list  and  consider  all  reaction  and  degradation 
products  in  the  authorisation  and  therefore  they  must  similarly  be  risk  assessed  by  the 
business operator according to international rules.  

Other  substances  including  polymer  production  aids  and  macromolecules  obtained  from 
microbial fermentation may be included in the list of authorised substances but may also  be 
used without an authorisation, subject to the businesses’ own risk assessment or national law. 

22 https://www.efsa.europa.eu/en/applications/foodcontactmaterials/regulationsandguidance. NB. Significant changes to this 

system have since entered into force in March 2021 as a result of the Transparency Regulation. 

11 

 
                                                 
 
Such exemptions are laid down in the plastics Regulation and there is no scope for businesses 
to  apply  for  derogations  for  those  substances  for  which  an  authorisation  is  compulsory,  i.e. 
monomers, other starting substances and additives, excluding colorants. 

3.2.  Other EU FCM legislation 
In order to take account of the provisions for waste reduction and thus the  need to prioritise 
recycling,  it  is  necessary  to  control  potential  incidental  contamination  from  substances 
originating  from  misuse,  cross  contamination  or  from  the  presence  of  materials  that  were 
intended  or  used  for  non-food  purposes.  Therefore,  Commission  Regulation  (EC)  No 
282/200823  sets  out  rules  for  plastic  recycling  processes  and  requires  the  adoption  of 
authorisation  decisions  addressed  to  individual  recyclers,  following  an  EFSA  assessment  of 
their recycling processes.  

At the time of this evaluation, the Commission was in the process of repealing and replacing 
the current Regulation24 and thereafter authorising recycling processes based on applications 
assessed by EFSA. In the meantime, recycled food contact plastics have been allowed subject 
to national rules, existing only in a few Member States.   

Technological developments in the area of food packaging intended to monitor the condition 
of the packaged food or influence its composition through the release of substances prompted 
the  need  to  derogate  from  the  general  requirements  on  inertness  set  out  under  the  FCM 
Regulation. Regulation (EC) No 450/200925, sets rules for the establishment of a Union list of 
authorised  substances  for  active  and  intelligent  materials  (AIM)  and  adopts  specific 
provisions  on  labelling  of  AIM,  declaration  of  compliance  and  supporting  documentation. 
Whereas EFSA has undertaken assessments of substances for use in AIM, the authorised list 
for AIM has not been established. 

Although  both  recycling  and  AIM  Regulations  are  in  force,  neither  has  been  fully 
implemented yet for reasons further discussed in section 5.4.  

Directive 84/500/EEC26 harmonised the rules on ceramic FCMs at the EU level for the release 
of  lead  and  cadmium,  and  sets  out  conditions  for  testing  the  migration  of  these  metals. 
However, as  exposure to  lead and cadmium  remain  too  high,  considerable reductions in  the 
current  limits  to  safeguard health  are needed  although many businesses would  consequently 
face  difficulties,  in  particular  small  or  micro  artisanal  companies,  as  well  as  medium  sized 
companies  using traditional manufacturing techniques.  These considerations are subject  to  a 
separate  impact  assessment  process  and  in  general,  ceramics  and  vitreous  materials  been 
considered as part of this evaluation process. 

In  addition  to  the  main  specific  legislation  at  EU  level  mentioned  above,  several  additional 
measures exist, addressing specific substances. These have been introduced following specific 
concerns  or  scientific  output,  including  measures  on  vinyl  chloride  monomer  (VCM)27,  N-

23 http://data.europa.eu/eli/reg/2008/282/oj  
24 https://ec.europa.eu/transparency/comitology-register/screen/documents/079492/3/consult?lang=en  
25 http://data.europa.eu/eli/reg/2009/450/oj  
26 http://data.europa.eu/eli/dir/1984/500/oj  
27 http://data.europa.eu/eli/dir/1978/142/oj  

12 

 
                                                 
 
nitrosamines and nitrosatable compounds in rubber teats28 as well as bisphenol A (BPA)29 and 
epoxy  derivatives30  in  materials  other  than  plastic.  Guidance  documents  have  also  been 
introduced  in  addition  to  EU  legislation,  in  particular  to  support  understanding  and 
compliance of the plastics Regulation. 

Figure  2  below  gives  an  overview  of  all  the  specific  rules  and  measures  in  place.  Annex  7 
contains  a  description  of  all  specific  measures  in  place  at  EU  level  and  relevant  supporting 
guidance documents.  

Figure 2: All specific measures in place for FCMs under Article 5(1) of the FCM 
Regulation 

3.3.  Documentation requirements 
All EU-specific measures require that FCMs to which they apply must be accompanied by a 
written  declaration  (declaration  of  compliance  or  ‘DoC’)  stating  that  they  comply  with  the 
rules  applicable  to  them.  Appropriate  documentation  must  also  be  made  available  to 
demonstrate  such  compliance.  For  plastic  FCMs,  these  rules  apply  at  all  of  the  marketing 
stages other than the retail stage, including final articles, products from intermediate stages of 
manufacturing and for the substances intended for the manufacturing of those  materials  and 
articles.  The  information  requirements  include  the  identity  of  the  business  operator,  the 
materials  and  substances  used  and  limitations  of  the  use  of  the  material  such  as  the 
temperature to which the materials can be subjected. 

The  written  DoC  must  confirm  that  the  products  comply  with  the  rules  and  should  be 
supplemented  by  appropriate  documentation  to  demonstrate  compliance,  such  as  conditions 

28 http://data.europa.eu/eli/dir/1993/11/oj  
29 http://data.europa.eu/eli/reg/2018/213/oj  
30 http://data.europa.eu/eli/reg/2005/1895/oj  

13 

 
 
                                                 
 
and results of testing,  calculations including modelling, other analyses, and evidence on the 
safety  or  reasoning  demonstrating  compliance.  Rules  for  experimental  demonstration  of 
compliance are set out in the plastics Regulation. 

3.4.  National legislation 
In  the  absence  of  specific  measures  at  EU  level,  Article  6  of  the  FCM  Regulation  allows 
Member  States  to  maintain  or  adopt  national  provisions.  The  2017  ‘baseline’  study7  by  the 
Commission’s JRC sets out a comprehensive overview of the current national legislation on 
FCMs in each Member State and identifies multiple pieces of legislation across the majority 
of Member States, covering most of the materials for which there are currently no EU-specific 
measures. 

Some Member States have also introduced national measures on BPA, although there are EU-
specific rules, under the safeguard measure provided for in Article 18 of the FCM Regulation. 
Further  risk  assessment  is  currently  being  carried  out  by  EFSA  to  determine  action  at  EU 
level. The impact of the national measures are examined in this evaluation.  

The FCM Regulation requires Member States to carry out inspections and official controls in 
order to enforce compliance with the Regulation and to lay down effective, proportionate and 
dissuasive sanctions in case of non-compliance. Official control work must be carried out in 
accordance with relevant provisions of Union law relating to official food and feed controls 
(Regulation  (EU)  2017/625).  The  work  is  supported  by  the  EURL-FCM31  at  the  JRC. 
Amongst other activities, it  develops testing methods, organises inter-laboratory comparison 
exercises  and  conducts  training  courses  for  the  benefit  of  National  Reference  Laboratories 
(NRLs)  and  experts  from  developing  countries.  It  also  produces  guidance  documents  to 
support compliance and enforcement work. 

In contrast to some other EU rules on food, no international regulatory framework currently 
exists for FCMs such as the Codex Alimentarius. The Council of Europe (CoE) has continued 
to publish non-binding policy statements on a number of FCMs including metals and alloys 
and  paper  and  board32.  International  standards  also  exist  for  ceramics,  both  at  the  level  of 
CEN and ISO, and standards for glass are often available in combination with ceramics. Table 
3 in annex 5 gives an overview of the different national measures and materials to which they 
are applicable. 

4.  METHOD 

Short description of methodology 

4.1. 
The Commission published a roadmap33 setting out the approach for this evaluation exercise 
in November 2017. Feedback on the roadmap was received from 26 stakeholders, which was 
taken into account. A supporting study was commissioned and launched in 2018, undertaken 
by  an  external  contractor.  Additional  work  to  complement  the  contractor’s  report  also 
provides essential input to the evaluation. This includes the JRC ‘baseline’ study7 as well as 

31 https://ec.europa.eu/jrc/en/eurl/food-contact-materials  
32 https://www.edqm.eu/en/publications-food-contact-materials-and-articles  
33 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1212-Evaluation-of-Food-Contact-Materials-FCM-  

14 

 
                                                 
 
two  supplementary  studies  done  by  DG  SANTE  on  controls  and  information  in  the  supply 
chain34. 
The  analysis  further  draws  on  a  number  of  parallel  and  related  EU  initiatives  on  other 
sectorial or horizontal legislation undertaken recently by the Commission. These include the 
Fitness Check on General Food Law35, the REFIT evaluation work on the mutual recognition 
(MR) principle36, on which FCMs rely, and the Fitness Check on the most relevant chemicals 
legislation37.  In addition,  EFSA published an opinion on developments  in risk assessment38, 
which has also provided evidence that has contributed to the evaluation. 

Stakeholders participated throughout the entire process, sharing experiences and views on the 
scope and the approaches set in the FCM Regulation, as well as to help identify any positive 
or negative effects. The consultation process included a strong representation of scientific and 
technical  expertise  from  both  public  (e.g.  national  authorities)  and  private  sectors  (e.g. 
businesses including SMEs and professional associations) as well as adequate representation 
from  consumer  and  civil  society  organisations,  including  NGOs.  Activities  included  a  12-
week  public  consultation,  workshops,  an  SME  Panel  Survey  and  focus  group  activities. 
Further details are available in the annexes and on the Commission’s website39. 

4.2.  Limitations and robustness of findings 
As  the  original  intervention  was  introduced  almost  45  years  ago,  the  reconstruction  of  the 
baseline prior to 1976 is largely descriptive and does not readily provide information as points 
of comparison in order to assess the evaluation criteria, for example impact on costs or health. 
Similarly,  EU-specific measures have been introduced since the  early 1980s  without  impact 
assessment work, to establish the situation at that time and to provide a quantitative baseline. 
Nevertheless,  the  implementation  of  national  legislation  in  the  absence  of  EU-specific 
measures beyond mainly plastics has provided a useful baseline, as well as quantitative points 
of comparison to evaluate the impact of EU-specific measures, in particular on plastic FCMs. 

It  has  been  difficult  to  comprehensively  quantify  costs  due  to  lack  of  robust  data.  The 
scientific  studies  and  the  contractor’s  report  include  some  relevant  data,  but  stakeholders, 
especially  businesses,  were  not  always  willing  or  able  to  share  information  on  compliance 
costs,  which  are  considered  confidential.  Industry  also  confirmed  particular  difficulties  in 
estimating  all  costs  from  presence  of  different  national  measures.  Henceforth,  in  order  to 
allow a quantitative comparison, surrogate figures or best estimates have been used based on 
the  best  available  data.  To  compensate  for  the  lack  of  hard  data,  the  work  encompassed 
several consultation exercises, including one-to-one interviews, case studies, focus groups and 
an SME Panel questionnaire, in addition to the 12-week public consultation and workshops. 
Ad hoc contributions have also been taken into account. 

34 https://ec.europa.eu/food/safety/chemical-safety/food-contact-materials/policy-initiatives/evaluation-eu-rules_en 
35 SWD(2018) 37 https://ec.europa.eu/food/safety/general_food_law/fitness_check_en  
36 SWD(2017) 475 https://ec.europa.eu/docsroom/documents/26975  
37 SWD(2019) 199 https://ec.europa.eu/info/publications/fitness-check-most-relevant-chemical-legislation-excluding-
reach_en  
38 https://doi.org/10.2903/j.efsa.2016.4357  
39https://ec.europa.eu/food/safety/chemical-safety/food-contact-materials/policy-initiatives/evaluation-eu-rules_en  

15 

 
                                                 
 
The  quantification  of  health  benefits  could  not  be  properly  established  due  to  the  lack  of 
available  information  which  is  sufficiently  robust  to  establish  a  causal  relationship  between 
the  introduction  of  EU  rules  on  FCMs  and  health  outcomes.  However,  attempts  have  been 
made  to  investigate  the  impact  of  an  intervention,  such  as  a  restriction  or  prohibition  for  a 
specific substance together with an estimation as to the extent to which the measure may have 
been beneficial to health. Further analyses have been made to try to gauge the extent to which 
the legislation may have contributed positively to health, in order to facilitate understanding 
of the efficiency. 

5.  ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS 
In order to carry out the evaluation, 10 questions were prepared covering the five evaluation 
criteria; effectiveness, efficiency, relevance, coherence, and EU added value. 

5.1.  Effectiveness 

To  what  extent  has  the  FCM  Regulation  and  subsequent  implementation  achieved  its 
objective  of  (Q1)  providing  the  basis  for  securing  a  high  level  of  protection  of  human 
health  and  the  interests  of  consumers  and  (Q2)  ensured  the  effective  functioning  of  the 
internal market in relation to the placing on the market in the EU in relation to FCMs? 

5.1.1.  Scope of the FCM Regulation, definitions and labelling 
The FCM Regulation covers materials intended for and already in contact with food but also 
those  which  can  reasonably  be  expected  to  come  into  contact  with  food  or  transfer  their 
constituents  into  food.  Information  collected  from  the  consultation  work  with  stakeholders 
indicates that the scope of the regulation is clear concerning the first two cases (Article 1(2)(a) 
and  (b)).  However,  around  40%  of  consultation  respondents  questioned  the  clarity  of  what 
constitutes “normal and foreseeable conditions of use”40 (Article 1(2)(c)) including almost all 
NGOs.  The  difficulty  of  fully  predicting  consumers’  behaviour  and  to  take  into  account  all 
possible  ways  they  may  use  or  re-use  FCMs  (see  section  5.3  on  relevance)  was  also 
highlighted in one of the focus groups.  

Typical examples include paper towels deployed in the kitchen setting and paper napkins used 
during  the  consumption  of  food  (see  case  example  1,  annex  6),  where  views  differ  on  their 
status as an FCM. Products not considered to fall within the scope of the FCM Regulation are 
governed  by  general  product  safety  or  REACH,  which  do  not  take  into  consideration  risks 
arising from the transfer of substances into food. They are also not subject to control under the 
Regulation (EU) 2017/625 on official controls. Thus if used for food contact they may pose a 
risk to health as indicated in case example 1. 

While  the  wine  glass  and  fork  symbol  (see  section  2.1)  should  inform  consumers  about  the 
suitability of an article for food contact, the public consultation shows that 30% of consumers 
are unclear or unsure of the meaning of that symbol37. Although not statistically significant, a 
larger  sample  size  (>1000  consumers)  taking  part  in  a  2019  survey  conducted  by  the 

40  Ecorys 

report:  public  consultation,  Part 

II.  Full 

summary 
regulation/initiatives/ares-2017-5809429/public-consultation_en.  Factual 
https://ec.europa.eu/food/system/files/2019-07/cs_fcm_20190616_summary-report.pdf  

results  available  at  https://ec.europa.eu/info/law/better-
July  2019 

report  published 

16 

 
                                                 
 
Federation of German Consumer Organisations (vzbv)41 put this figure at over 50%, similar to 
the understanding of the AIM symbol (annex I of Commission Regulation (EC) No 450/2009) 
determined  during  the  public  consultation.  Earlier  survey  work  on  silicon  articles  on  the 
German  market42  found  that  when  use  instructions  were  given  exclusively  in  the  form  of 
pictograms without further wording, those were rarely self-explanatory and often difficult to 
read because the imprint was blurred and in the same colour as the product. Identification and 
communication  of  information  to  consumers  therefore  seems  partly  unclear,  which  is  also 
identified under the chapter on relevance. 

In contrast, the wine glass and fork logo is often seen on types of packaging for which it is 
difficult  to  re-use  with  food  in  any  context,  such  as  carton-board  packaging,  and  therefore 
cannot be aimed at consumers. It raises the possibility that the symbol may be used as a quick 
and easy way for businesses to indicate legal compliance in the supply chain. 
The  majority  of  respondents  from  the  public  consultation37  consider  that  the  definitions  in 
Article 2 of the FCM regulation are sufficient and clear, with the exception of NGOs, most of 
whom perceive the current definitions provided by the legislation as not sufficient, although it 
is not clear on what basis this opinion is formed. However, it may be that the definitions are 
clear from the perspective of the respondent, but that respondents would not necessarily agree 
on their meaning. As regards specific measures, discussions frequently occur on definitions of 
different  material  types,  for  example  on  whether  certain  elastomeric  products  fall  under  the 
definition  of  ‘plastic’  in  Regulation  (EU)  No  10/2011,  or  may  rather  be  considered  as 
‘rubber’, which are not in the scope of the plastics Regulation. Generally, therefore, it can be 
concluded that although definitions appear clear, their interpretation depends strongly on the 
perspective of the stakeholder, leading to possible confusion and different applications of the 
legislation. 

5.1.2.  Traceability 
FCMs should be traceable throughout the distribution chain up to the raw materials to ensure 
effective  action  in  terms  of  non-compliance.  During  the  public  consultation,  almost  three-
quarters of businesses indicated that they consider traceability requirements to be sufficiently 
detailed whereas less than half of public authorities agreed with this37. In addition to the FCM 
Regulation, industry associations have provided guidance that defines requirements to ensure 
traceability  with  examples43.  The  Nordic  Council  of  Ministers  has  developed  a  traceability 
checklist on FCMs44. Conversely, the evidence from audit and fact-finding missions, as well 
as  discussions  with  Member  States,  indicate  some  general  difficulties  with  accessibility  of 
information  across  the  supply  chain,  particularly  where  different  businesses  operate  in 
different  Member  States,  where  coordination  between  different  competent  authorities  is 
challenging and where documents are only available in paper format.  

As  well  as  guidance,  stakeholders  indicate  that  traceability  is  enhanced  when  a  DoC  and 
supporting  documentation  (SD)  is  required,  in  the  case  of  plastic  FCMs  for  example,  since 

41 https://www.vzbv.de/sites/default/files/downloads/2020/09/25/20-08-
20_befragung_lebensmittelkontaktmaterialien_ergebnisse_1.pdf  

42 https://www.verbraucherzentrale.de/sites/default/files/migration_files/media235769A.pdf  
43 https://www.apeal.org/wp-content/uploads/2015/04/1.-Industrial-Guidelines-Traceability-Jan2006.pdf  
44 http://norden.diva-portal.org/smash/record.jsf?pid=diva2%3A702301&dswid=1800 

17 

 
                                                 
 
these documents contain information such as the name and address of the legally responsible 
business. In the absence of these specific requirements, there is an indication that traceability 
may  be  compromised  since  businesses  must  make  specific  efforts  to  provide  traceability, 
rather than simply filling in  a DoC. However, no examples  or evidence  have been found of 
specific problems that have led to major difficulties, for example, in withdrawing or recalling 
FCMs from the market. Some Member States such as Denmark, Spain (with a reference to an 
industry guideline), Poland, Slovenia, Estonia and Norway have requirements for registering 
businesses,  which  helps  as  regards  traceability.  This  is  touched  on  again  in  section  5.1.7 
concerning  inspections  and  controls.  Overall,  there  appears  to  be  room  for  improvement  in 
EU  traceability  requirements,  which  are  currently  supplemented  by  self-guidance  (i.e. 
standards set by industry bodies) or information in a DoC. 

5.1.3.  General requirements on safety 
The  general  legal  requirement  on  safety  laid  down  in  Article  3  of  the  FCM  Regulation  has 
acted to a certain extent as a driver for pushing safety standards and improving the protection 
of  human  health.  This  includes  the  EU-specific  measures  in  place  in  addition  to  the  main 
safety  requirement  in  Article  3  of  the  FCM  Regulation.  Member  States  have  introduced 
national specific rules which support the achievement of safety. Output from EFSA has also 
helped to facilitate the understanding of safety and compliance22 concerning the migration of 
substances that can be applied regardless of whether substances are subject to authorisation at 
EU level. Numerous industry guidelines have also been introduced, which have been designed 
to ensure safety and facilitate businesses in demonstrating compliance, such as the CEPI Food 
Contact Guidelines for the Compliance of Paper and Board Materials and Articles45.  
It should be noted that some of these benefits may have materialised even in the absence of 
Article  3,  but  not  necessarily  consistently  throughout  the  EU  and  to  varying  degrees.  For 
example, prior to 1976, some Member States had already started to introduce specific rules on 
FCMs and this appears to be the case for FCMs not subject to specific EU rules. Article 3 in 
isolation is insufficient to be effective at achieving the aims of the legislation, since it does not 
define  the  level  of  safety  expected,  how  this  should  be  achieved  or  how  it  can  be 
demonstrated. Since safety is not absolute and views differ between stakeholders on how to 
define levels of safety and demonstrate compliance, some stakeholders, in particular industry, 
find that Article 3 on its own is not effective at providing a level playing field across the EU 
to support the functioning of the internal market46. Others, including NGOs, argue that gaps 
exist concerning the safety of FCMs47. Further analysis on this is carried out in section 5.1.5. 
The  effectiveness  of  the  requirements  concerning  the  effect  of  FCMs  on  the  organoleptic 
qualities of food appears questionable because of a lack of agreement and definition of what 
constitutes  a  “deterioration  in  the  organoleptic  characteristics”  of  food.  There  have  been 
unsuccessful attempts at solving issues with sensory science on an EU level, including a JRC 
workshop in 201148. Furthermore, a key issue identified during the workshop was the lack of 

45 https://www.cepi-eurokraft.org/wp-content/uploads/2019/04/Food-Contact-Guidelines_2019.pdf  
46 Stakeholder perspectives Cross-Sector Group, inaugural workshop 24 September 2018 
47 Stakeholder perspectives NGOs, inaugural workshop 24 September 2018  
48 https://ec.europa.eu/jrc/sites/default/files/Simat-presentation-FCM-sensory-workshop-20111129.pdf  

18 

 
                                                 
 
harmonised EU standards or guidance on testing procedures. As noted by the JRC ‘baseline’ 
study7,  the  extent  of  approaches  is  different  between  different  Member  States,  with  some 
having  internal  standards,  while  others  following  CEN/ISO  standards.  Case  example  2  in 
annex 6 outlines some practical problems on this topic.  

Little information is available on the effectiveness of Article 3(2) which prohibits misleading 
of  consumers,  aside  from  recent  cases  involving  so-called  ‘eco-friendly’  FCMs49.  Very  few 
RASFF notifications have been raised on incorrect labelling or advertising of FCMs, which in 
any  case  may  also  relate  to  safety  concerns  and  therefore  non-compliance  with  Article  15. 
This may indicate that the requirement is effective at dissuading businesses from misleading 
advertising, or perhaps reflects the lower priority given to its enforcement. 

5.1.4.  Specific EU rules introduced under Article 5 of the FCM Regulation  

Union lists of authorised substances including risk assessment 

The  requirement  to  generate  scientific  data,  the  risk  assessment  by  an  independent  EU 
scientific body and corresponding risk management measures introduced by the Commission 
and agreed upon by Member States has ensured a well-established, well-defined and agreed 
level  of  safety  that  has  been  achieved  for  starting  substances  and  additives  used  in  the 
manufacture  of  plastic  FCMs  at  EU  level.  Most  stakeholders  agree  that  this  process  is 
effective  in  ensuring  their  safety,  including  businesses  and  Member  States  according  to  the 
public  consultation.  Indeed,  Member  States  also  use  the  scientific  guidance22  provided  by 
EFSA for risk assessment as a basis for their own risk assessment work50. The approach has 
therefore been generally effective at ensuring the safety of starting substances and additives in 
plastic FCMs. 

There is a consensus, particularly from businesses involved in the plastic FCM supply chain, 
that the approach is  effective in  contributing towards the smooth  functioning of the internal 
market40,  51.  The  approach  means  that  rules  on  the  use  of  starting  substances  are  the  same 
throughout  the  EU  and  thus  contribute  effectively  to  the  functioning  of  the  internal  market. 
The  list  of  authorised  substances  has  provided  legal  certainty  to  businesses  on  what 
substances can be used, which in turn has facilitated business investments and exchange in the 
supply  chain.  The  impact  appears  positive  compared  with  the  situation  prior  to  the 
establishment of the list and in particular in comparison to sectors that trade FCMs for which 
there is no EU authorised list, as these sectors face different national contexts both at the stage 
of risk assessment of substances and in their use in plastic FCMs. 

Development  of  a  Union  list  has  also  led  to  rules  on  the  technical  quality  and  purity  of 
substances,  general  restrictions  such  as  an  overall  migration  limit  (OML)  and  specific 
restrictions such as SMLs. These are particularly important mechanisms to ensure exposure to 
substances stays below a safe level and usually reflect a health-based guidance value such as a 
tolerable daily intake (TDI) established by EFSA, below which a risk is considered not to be 
present. In setting an SML, the Commission also takes into account other possible sources of 
exposure  to  the  substances  where  information  indicates  it  is  necessary.  This  recognises  that 

49 https://www.beuc.eu/publications/beuc-x-2021-050_towards_safe_and_sustainable_fcm._report.pdf  
50 Ecorys report: Focus group 5 “Risk assessment and risk management” 
51 Ecorys report, annex 2: Case study 1 “From application to market” 

19 

 
                                                 
 
consumers may also be exposed to the same substances that are present in other products as 
well  as  their  presence  in  the  environment  including  the  air.  Consequently,  these  restrictions 
complement the authorisations and enhance consumer protection. 

The  effectiveness  of  the  approach  is  however  limited  in  several  ways.  Currently,  over  900 
substances are authorised for use in the manufacture of plastic FCMs. This represents no more 
than  around  10%  of  the  overall  number  of  substances  used  in  FCM  manufacture,  which  is 
broadly estimated to be around 10 000 (although plastic accounts for the greatest proportion 
of  all  FCMs  on  the  market6).  Not  all  these  substances  are  toxicological  relevant,  but  the 
current approach does not automatically focus on those substances with the highest risks. The 
lack of specific rules beyond mainly plastics is, according to stakeholders, a major problem – 
either  because  it  does  not  guarantee  safety  of  other  materials  or  because  trade  in  other 
materials is hampered by a lack of consistent rules on how compliance to ensure safety should 
be achieved. 

The  approach  is  weakened  because  new  scientific  knowledge  is  not  reflected  in  a  timely 
manner in the authorisations. Such knowledge on many substances has become increasingly 
available  over  the  years,  generated  for  example  by  REACH  requirements,  independent 
scientific research or reviews by other assessment bodies. This is particularly pertinent given 
that  a  significant  number  of  the  substances  that  are  authorised  were  assessed  decades  ago. 
While a mechanism for update exists that must be triggered by any user of the substances, or 
can be started by Member States or the Commission, this mechanism does not work.  
In recent years, the Commission has asked EFSA to re-assess phthalates52 and styrene53, and 
various requests were received from Member States to re-assess certain substances authorised 
in plastic FCMs, such as phenol54. There is a legal obligation under the FCM Regulation for 
applicants or users of a substance to report new relevant data, although this has happened very 
infrequently.  While  industry  has  provided  new  data  together  with  existing  data  in  REACH 
registrations, FCM dossiers have not been updated at the same time. A possible reason may be 
that while there is a dedicated applicant for authorisation, once a substance is authorised, there 
is no authorisation holder; the original applicant may cease to exist and consequently there is 
a limited responsibility for the update of the substance. Other sectors such as plant protection 
products55, have a built in renewal or review period for the approval of active substances not 
lasting more than 15 years. Case example 3 in annex 6 provides a practical example.  
NGOs  as  well  as  the  European  Parliament56  have  expressed  concerns  that  the  current 
approach  in  the  risk  assessment  and  management  of  FCM  substances  does  not  sufficiently 
take into account vulnerable populations, unlike other sectorial legislation as identified in the 
EU Chemicals Fitness Check37. According to a 2016 opinion by EFSA38, a more refined risk 
assessment  of  substances  is  necessary  but  is  not  feasible  with  the  current  risk  management 
approach  due  to  the  consequential  demand  on  resources  and  practical  complexities,  such  as 
multiple SMLs for the same FCM. EFSA also considers that the final FCM or article should 

52 https://doi.org/10.2903/j.efsa.2019.5838  
53 https://doi.org/10.2903/j.efsa.2020.6247  
54 https://doi.org/10.2903/j.efsa.2013.3189  
55 http://data.europa.eu/eli/reg/2009/1107/oj  
56 Report on the implementation of the Food Contact Materials Regulation ((EC) No 1935/2004) (2015/2259(INI)) 

20 

 
                                                 
 
be  evaluated  for  its  safety  rather  than  the  starting  substances.  However,  the  Regulation  is 
drafted on the premise that it is possible to determine the safety of the final material based on 
its starting substances. The approach used in the plastics Regulation would therefore require 
fundamental changes to accommodate for this. 

A number of stakeholders and in particular NGOs are concerned that the current legislation is 
not sufficiently effective at taking into account the possible combination effects of substances 
migrating from FCMs, in particular that the toxicity of combinations of substances could be 
larger than that of individual substances57. Although such phenomena have, for the moment, 
been observed only in a few cases58, it is acknowledged in the EU Chemicals Fitness Check37 
as a gap and area in which there is the need for dedicated studies. In 2019, EFSA published 
guidance  for  the  assessment  of  this  phenomenon  (EFSA  2019)59.  This  will  help  in 
contributing to the risk assessment of the combination effects of migrants released by FCMs.  

Substances for which a derogation applies and that are not subject to authorisation 
The effectiveness of the legislation on plastic FCMs is also weakened by several derogations 
that  exist  for  the  assessment  and  authorisation  of  substances  at  EU  level.  Historically, 
information  has  been  readily  available  on  monomers  and  additives  that  are  used  in  higher 
concentrations.  The  process  has  excluded  substances  such  as  polymer  production  aids, 
colorants, solvents and aids to polymerisation, which are either used in smaller quantities or 
not intended to remain in the material. Often, the substances are subject to national legislation 
and self-assessment, which has led to differences in actions taken across Member States and 
industry.  

This  is  exemplified  in  the  limits  and  testing  methods  for  colorants  set  by  Member  States 
despite the existence of the CoE Resolution AP 89(1)60. The Dutch Warenwet61 and German 
BfR  Recommendations62  II  and  VII  require  a  positive  listing  for  aids  to  polymerisation,  but 
according  to  industry,  when  production  is  sourced  outside  these  countries,  it  is  difficult  to 
receive  information  on  the  status  of  these  substances.  In  the  public  consultation40,  public 
authorities and businesses expressed the opinion that to provide more effective protection of 
public  health,  the  Union  list  for  plastics  should  also  include  these  substances  currently 
covered by derogations. 

The plastics Regulation focuses on substances used to produce plastics under the assumption 
that  the  reacted  polymer  is  substantially  less  toxic  than  its  starting  substances.  To  manage 
other  substances  available  in  the  final  product  in  addition  to  the  overall  migration  limit,  all 
substances  in  plastic  FCMs  including  NIAS  that  do  not  require  an  authorisation  should  be 
assessed  using  “internationally  recognised  scientific  principles  on  risk  assessment”. 
Assessment  of  NIAS  has  therefore  been  the  responsibility  of  industry,  which  has  published 

57 https://chemtrust.org/wp-content/uploads/ct-additionalevidence-ecorys-sep19.pdf  
58 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6135635/  
59 https://doi.org/10.2903/j.efsa.2019.5634  
60 https://rm.coe.int/16804f8648  
61 Dutch Consumer act Warenwet, 2017, English version: http://www.adfopack.nl/assets/dutch-packagings-and-consumer-

articles-regulation-from-january-2017-(20122016).pdf  

62 https://www.bfr.bund.de/en/bfr_recommendations_on_food_contact_materials-1711.html  

21 

 
                                                 
 
recommendations and guidance documents addressing  the evaluation of NIAS (ILSI 201663, 
CEPE 201864, EuPIA 201965).  
In  more  recent  times,  EFSA  has  started  to  assess  NIAS  as  far  as  possible,  recognising  that 
they  too  may  present  a  risk  that  needs  to  be  assessed.  EFSA  has  provided  some  partial 
recommendations  on possible ways to  assess  them38,  but  a  lack of clear  and comprehensive 
EU rules appears to hinder the adoption of a single harmonised approach by all stakeholders. 
The  discovery  of  cyclo-di-badge66  as  a  NIAS  in  coatings  has  recently  led  to  challenges 
because of differences in interpretation between industry and Member States.  
Despite  scientific  improvements67,68,  identification  and  assessment  of  all  possible  NIAS  are 
still  very  challenging,  if  not  impossible  in  practice.  Whilst  EU  rules  require  NIAS  to  be 
considered,  many  participants  in  the  consultation  work  consider  that  there  is  insufficient 
information or guidance agreed upon at EU level. Furthermore, almost  90%  of  the  companies 
asked40 reported  that they  do not  receive adequate information  on NIAS  from suppliers  and 
therefore  information  flow  on  NIAS  is  lacking.  Case  example  4  in  annex  6  provides  an 
illustration  of  the  NIAS  issue.  In  conclusion,  clearer  EU  rules  and  delegation  of 
responsibilities in the supply chain on substances that are subject to derogations are needed to 
improve effectiveness and to better ensure the safety of final FCMs. 

Rules for verification of compliance 

The  plastics  Regulation  is  supplemented  by  guidance  documentation,  including  the  EU 
Guidance on the application of the plastics Regulation69 with further supplementary guidance 
on information exchange in the supply chain70 and testing guidelines developed by the EURL-
FCM71.  According  to  stakeholders,  this  guidance  is  essential  to  being  able  to  fulfil  their 
compliance work, which in turn ensures safety. Given the constraints of the legal text, these 
guidance  documents  have  proved  popular  with  industry  stakeholders  and  in  particular 
Member  States’  authorities40,72  who  consider  them  helpful  in  understanding  the  Regulation, 
which is technically complex and demanding to understand and ensuring compliance. Further 
work on migration testing guidelines by the EURL-FCM is ongoing and eagerly awaited by 
stakeholders. Specific EU guidance therefore complements the legal requirements enhancing 
effectiveness in achieving the objectives. 

A survey on DoC and SD undertaken by DG SANTE73 in 2017 in which 227 businesses, 59 
trade  and  business  associations  and  230  public  authorities  participated,  showed  that  the 
documentary system  based on  DoCs and SD has  become common practice within the FCM 
sectors, with  the use of DoCs  even for  FCMs  for which there are no  EU-specific measures. 

63 https://ilsi.eu/wp-content/uploads/sites/3/2016/04/2015-NIAS_version-January-2016.pdf  
64,https://www.cepe.org/wp-content/uploads/2018/05/TSC33-NIAS-GUIDELINES-May-2018-v1.7.4.pdf  
65 https://www.eupia.org/fileadmin/Documents/Risk_Assessment/2019-02-21_EuPIA_NIAS_Guidance.pdf    
66 Cyclo-di-badge is a reaction product formed from BPA and BADGE during epoxy resin production 
67 https://fcm.wiv-isp.be  
68 https://doi.org/10.1080/19440049.2019.1664772     
69 https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_en.pdf  
70 https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf  
71 https://ec.europa.eu/jrc/en/eurl/food-contact-materials/technical-guidelines  
72 Ecorys report, annex 2: Case study 3 “Compliance along the supply chain” 
73 https://ec.europa.eu/food/system/files/2022-04/cs_fcm_eval_btsf_20220419_controls-sum.pdf  

22 

 
                                                 
 
Businesses  report  that  they  usually  receive  DoCs  from  their  suppliers  but  that  obtaining 
adequate  supporting  information  through  the  whole  of  the  supply  chain  is  more  difficult, 
citing confidentiality issues and a lack of knowledge, particularly among SMEs. Checks are 
mainly  limited  to  visual  identity  checks  with  only  11%  of  business  operators  analytically 
checking SMLs/OMLs and the authorisation status of substances.  

The  analysis  of  DoCs  provided  shows  that  most  contain  basic  information  and  mention 
compliance  with  the  FCM  Regulation  and  the  plastics  Regulation.  The  main  shortcomings 
were in referencing rules on GMP, clear identification of substances used, dual use additives, 
functional  barriers  and  specifications  on  the  adequate  use.  Few  provided  the  identity  of 
upstream suppliers. Overall, many DoCs were incorrectly filled-in and incomplete. 

Trade  business  associations  represent  an  important  channel  for  information,  providing 
industry  guidelines,  information  and  advice  on  compliance  work  and  legislation  to  their 
members.  Most  mentioned  issues  in  the  functioning  of  information  in  the  supply  chain, 
frequently mentioning the lack of a  common structure for DoCs,  lack of  capacity of SMEs, 
lack  of  clarity  of  responsibilities  and  varying  degrees  of  knowledge  on  FCMs  along  the 
supply chain. An overview of the main difficulties mentioned in the public consultation has 
also  been  summarised40.  A  study  by  enforcement  authorities74  has  also  underlined  that 
following  a  request  by  Member  States,  the  chemical  industry  could  not  provide  adequate 
supporting documentation showing that they comply with the FCM Regulation.  

Although it is  accepted that downstream users are better placed to estimate likely consumer 
exposure,  they  do  not  currently  have  access  to  necessary  information  that  is  contained  in 
confidential  documentation  supporting  DoCs  of  the  chemical  industry.  A  mechanism  that 
would  relax  the  confidentiality  of  this  supporting  documentation  could  “contribute  to 
improved assessment of the compliance of the FCM put on the market by downstream FCM 
users”  (Grob  2019).  Case  example  5  in  annex  6  describes  a  situation  concerning  a  lack  of 
transfer of information in the supply chain. 

Overall, it can be concluded that some gaps exist in the flow of information along the supply 
chain  and  in  enforcement  by  control  authorities  that  undermine  the  effectiveness  ensuring 
compliance and safety of FCMs. 

5.1.5.  FCMs  not  subject  to  EU-specific  rules  and/or  subject  to  national  rules  as 
provided for by Article 6 of the FCM Regulation and mutual recognition  
According  to  the  JRC  ‘baseline’  study7,  some  materials  are  regulated  by  many  different 
Member  States,  such  as  metals  or  paper  and  board.  However,  legislation  differs  somewhat 
across  the  EU.  Although  there  is  extensive  use  of  lists  of  substances,  which  are  either 
authorised for use or considered safe, which cover close to 8000 substances, less than 20% of 
substances are in common in three or more Member States (table 4, annex 5).  

Differences  between  Council  of  Europe  and  Member  States’  lists  of  substances  suggest  a 
limited  transposition  of  Council  of  Europe  Resolutions.  Where  the  same  substance  is 
regulated in different Member States, the type of restriction (migration, compositional limits, 

74  McCombie  G,  Hötzer  K,  Daniel  J,  Biedermann  M,  Eicher  A,  Grob  K.  2016.  Compliance  work  for  polyolefins  in  food 
contact: results of an official control campaign. Food Control. 59:793–800. 

23 

 
                                                 
 
quantity  in  materials)  also varies. For  example,  11 Member States have legal  provisions for 
varnishes  and  coatings,  but  these  have  common  requirements  for  only  88  out  of  1720 
substances, and may differ in terms of the definition of use and their categorisation.  

Less than half of substances regulated nationally are in lists that EFSA has previously found 
to be adequately risk assessed75. National risk assessment schemes and requirements for the 
authorisation of substances are not the same in all Member States and often differ from that of 
EFSA.  Their  access  is  limited  and  often  it  is  not  possible  to  determine  in  detail  how 
conclusions have been reached, in contrast to the transparency of EFSA’ work.  

These aspects, together with difficulties reported by businesses to access information and their 
availability only in national languages, are considered a large burden for industry and barriers 
to  trade.  It  leads  industries  to  seek  external  legal  advice,  which  results  in  lengthier 
authorisation  processes  and  delayed  market  access.  It  also  results  in  greater  focus  on 
certification and accreditation systems  at  industrial  level.  According to  various sectors, they 
have  increasingly  tended  to  seek  global  food  contact  compliance  in  non-EU  legislation  to 
overcome the lack of coherent rules at EU level. The results are substantiated by the findings 
of  the  supporting  study  including  the  public  consultation40  and  specific  difficulties  for  the 
rubber sector are set out in one case study76. 
Where no specific EU  rules exist, the mutual  recognition  principle77 should apply to  ensure 
market  access  for  products  that  are  not  subject  to  EU  harmonisation.  However,  there  is  a 
widely shared view among FCM industry representatives that the mutual recognition system 
is not working properly in the sector (see  figure 3 below), which constitutes a barrier to the 
functioning of the internal market. In many cases, rules in one Member State may differ from 
those  in  another  since  according  to  EU  law,  justification  can  be  given  based  on  overriding 
reasons of public interest and which are proportionate to the aim pursued. 

Figure 3: Opinion on the application of the mutual recognition principle40 

The application of the mutual recognition principle functions well in the area of FCM

Total

5%

9%

15%

18%

40%

14%

Public authority

5%

16%

16%

24%

16%

22%

Businesses

5%

8%

15%

19%

41%

12%

NGOs

80%

Other

11%

11%

22%

11%

28%

20%

17%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Strongly agree

Moderately agree

Neither

Moderately disagree

Strongly disagree

No opinion

75 https://doi.org/10.2903/sp.efsa.2011.EN-139  
76 Ecorys report, annex 2: Case study 2 “Effect of lack of EU specific rules and application of national specific rules” 
77 http://data.europa.eu/eli/reg/2008/764/oj  

24 

 
 
 
 
                                                 
 
The application of the mutual recognition principle has always been  challenging and typical 
barriers to effective mutual recognition stem from Member States’ application and knowledge 
of the principle, and from companies’ lack of awareness of the principle78. The staff working 
document (SWD) on the evaluation of mutual recognition79 also highlights the need for more 
reliable monitoring tools and better data on the functioning of the mutual recognition system. 
Both  the  evaluation  and  impact  assessment  for  a  new  regulation80  concluded  that  the 
interrelationship  between  the  FCM  Regulation  and  the  mutual  recognition  Regulation  (EC) 
No 764/200881 was not clear to economic operators, in particular in terms of the principles and 
scope of application of the latter and its ability to facilitate compliance with specific national 
rules.  Case  example  6  in  annex  6  gives  an  overview  of  some  practical  examples  where 
additional costs and burdens to industry have been experienced. 

Since  the  evaluation  of  the  mutual  recognition  principle,  a  new  Regulation  2019/51582  has 
been  adopted  and  has  applied  since  19  April  2020.  It  has  sought  to  address  the  problems 
established  by  the  evaluation,  including  the  assessment  procedure  to  be  followed  by 
competent  authorities  when  assessing  goods  as  well  as  a  business-friendly  problem  solving 
procedure,  based  on  SOLVIT83,  that  includes  the  possibility  of  an  assessment  from  the 
Commission on the compatibility of a decision restricting or denying market access with EU 
law.  This  should  help  FCM  businesses,  but  the  impact  of  these  changes  will  need  to  be 
assessed in time. 

Overall, the situation created by a lack of EU-specific measures beyond plastic FCMs, and a 
multitude of national measures has created legal  uncertainty, barriers to businesses and  may 
create confusion over required or acceptable levels of safety. 

5.1.6.  Good Manufacturing Practice (GMP) 
Many stakeholders consider that the current EU rules on GMP are not sufficiently detailed in 
the  legislation  to  enable  FCMs  to  be  manufactured  to  a  high  standard,  particularly  Member 
States’ authorities and most NGOs40. However, the introduction of basic rules has prompted 
industry  to  address  GMP  in  different  sectors,  and  only  in  very  specific  cases  has  EU 
intervention been necessary, in particular in the case of preventing migration of printing ink23. 
Since  2006,  sectorial  GMP  guidelines  have  been  introduced  by  industry,  that  are  better 
adapted to the specific supply chain situation and needs and with specific expert knowledge.  
Examples of such sectorial GMP guidelines include those issued by the ink84 and paper and 
board45  industries.  Indeed,  the  most  comprehensive  GMP  guidance  documents  appear  to  be 
those for paper and board, which also include guidance from Nordic countries85 and which are 
considered  useful  in  helping  to  ensure  GMP  for  this  sector.  The  Swiss  Packaging  Institute 

78 http://ec.europa.eu/DocsRoom/documents/13381/attachments/1/translations/en/renditions/native [27.10.2019] 
79 https://ec.europa.eu/info/publications/evaluation-mutual-recognition_en  
80 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2017:0471:FIN [27.10.2019] 
81 http://data.europa.eu/eli/reg/2008/764/oj 
82 http://data.europa.eu/eli/reg/2019/515/oj 
83 https://ec.europa.eu/solvit/index_en.htm  
84 https://www.eupia.org/key-topics/food-contact-materials/good-manufacturing-practice-gmp  
85 Norden guidelines on paper and board "Paper and Board Food Contact Materials", (TemaNord 2008:515) 

25 

 
                                                 
 
(SVI)  has  developed  and  revised  a  checklist  for  industry  to  assess  DoC86, which  is  used  by 
inspectors for controls. 

However, it is not always clear whether these guidelines are used in practice by the members 
at national and local level, especially among SMEs. There are references to GMP in a number 
of Member States and a full guidance has recently been developed by Italy87, although it has 
not been possible to evaluate the extent to which this is effective.  

Sector specific guidelines are also provided by some Member States, although these are often 
conceptual  and  require  further  elaboration  by  industry.  Stakeholders  including  NGOs  and 
some  interviewed  business  associations  have  expressed  a  preference  for  integrating  GMP 
requirements  into specific measures rather than having a separate GMP  Regulation, i.e. that 
GMP is not sector specific enough at present to be sufficiently effective88. 

Moreover, stakeholders (from all categories) mention difficulties in ensuring that, in the case 
of  products  imported  from  third  countries,  the  manufacturing  process  is  in  line  with  GMP 
requirements.  Results  from  the  public  consultation,  across  all  categories,  show  that  most 
respondents  are concerned about  the application of GMP  in third countries40. In  conclusion, 
the basic requirements on GMP have stimulated industry to implement self-guidance on GMP 
with  more  sector  specific  rules.  However,  there  is  some  uncertainty  on  the  extent  to  which 
GMP guidelines are taken up and used in practice. 

5.1.7.  Inspection and official controls by Member States’ competent authorities 
The  Regulation  (EU)  2017/625  on  official  controls  explicitly  captures  the  manufacture  and 
use  of  FCMs:  FCM  operators  are  explicitly  included.  Controls  should  be  undertaken  on 
products, substances and materials that may influence food safety, including food processing 
equipment  and  packaging.  Official  controls  should  include  an  examination  of  compliance 
already  established  by  the  business  operators  and  procedures  on  GMP.  Member  States’ 
competent  authorities  must  take  account  of  previous  records  on  compliance  as  well  as  the 
reliability and results of businesses’ own controls that have been performed by themselves, or 
by  a  third  party  at  their  request,  including,  where  appropriate,  private  quality  assurance 
schemes,  for  the  purpose  of  ascertaining  compliance.  Member  States’  competent  authorities 
must  draw  up  and  keep  up-to-date  a  list  of  FCM  business  operators.  Non-compliances  are 
typically  reported  via  the  Rapid  Alert  System  for  Food  and  Feed  (RASFF)  or  the 
Administrative Assistance and Cooperation (AAC) system. 
Typically, RASFF notifications on FCMs make up a small proportion of all RASFF reports89. 
To  some  extent,  this  may  reflect  priorities  set  by  Member  States  on  controls.  However,  the 
findings are also generally limited by a significant lack of accredited methods for authorised 
substances  in  plastic  FCMs  because  of  the  large  number  of  substances  and  combination  of 
those substances  with  plastic matrices, conditions  of use, etc.  This  is  also discussed later in 

86 CH- SVI - Bewertung von Konformitätserklärungen. 
87 IT- Guidelines for the application of the Regulation 2023/2006. Rapporti Istisan 11/37- CAST project: ISSN 1123-3117.  
88 https://chemtrust.org/wp-content/uploads/chemtrust-fcm-position-paper-may19.pdf  
89 https://webgate.ec.europa.eu/rasff-window/portal/?event=searchForm&cleanSearch=1 Over the period 2010-2018, FCM-
related RASFF notifications (n=1,764) accounted for 6% of the total number of food alert notifications in the RASFF 
database (n=25,704), compared with 7% for feed and 87% for food) 

26 

 
                                                 
 
section  5.3  on  relevance.  Member  States’  competent  authorities  are  therefore  in  reality 
enforcing only a very small number of the SMLs set for different substances (<5%) that have 
high  visibility  and/or  for  which  dedicated  measures  exist  or  are  easy  to  test  for.  Member 
States are therefore able to carry out inspections and controls in a very limited capacity. 

Performance of Member States  
Commission visits and audits of 22 national control systems90 between 2007 and 2011 found 
that  many  (mainly  new)  Member  States  had  only  just  started  implementing  controls  and 
further  efforts  were  needed  to  develop  the  control  systems,  like  an  elaboration  of  specific 
guidelines, upgrading of laboratories and specific training. Moreover,  competences were not 
sufficiently clear, resulting in either a lack – or an overlap – of official controls. Risk-based 
official controls at FCM manufacturing level were not well established and staff was lacking 
sufficient training on FCM related issues, such as assessments of documentation, traceability 
systems and GMP principles.  

Follow-up audits in 2017 and 201891 together with two workshops confirmed that deficiencies 
remained, with the following conclusions: 

  Official  controls  on  FCMs  in  Member  States  are  in  general  weak,  not  sufficiently 

effective and considered a low priority. 

  Controls  are  often  limited  to  the  verification  of  the  presence  of  the  DoC,  with 

inspectors rarely having the expertise to verify its content. 

  Businesses involved in the FCM chain can only be identified to a limited extent. 

  Underlying problems identified include: 

  Lack 

of 
inspections; 

regular 

dedicated 

  Lack of expertise and experience at 

the front-line control level; 

  Inability  to  identify  all  relevant 

businesses; 

  Lack of comprehensive checklists; 
  Lack  of  guidance  documentation, 
the  evaluation  of 

including  on 
DoCs; 

  Lack  of  effective 

training 

for 

inspectors; 

  Laboratories have neither the resources 
nor  the  ability  to  perform  analytical 
checks  on  samples  not  foreseen  by 
established control plans; 

  Enforcement measures and/or sanctions 

are not systematically imposed; 

  Poor  documentation  of  controls  and 
few records of cases of non-compliance 
hampers future risk-based planning; 

  Industrial 

equipment 

is 

often 

overlooked during official controls. 

Overall,  the  current  systems  of  official  controls  cannot  adequately  or  fully  enforce  the 
requirements of the legislation, although this does not imply that FCMs are unsafe. 

One key problem, the lack of a systematic registration system for businesses, currently only in 
place  in  eight  Member  States,  is  expected  to  be  helped  through  Article  10(2)  of  Regulation 
2017/625  on  official  controls  (which  entered  into  force  on  the  14th  December  2019) 

90 https://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm  
91 https://ec.europa.eu/food/audits-analysis/overview_reports/act_getPDF.cfm?PDF_ID=1732  

27 

 
                                                 
 
introducing  a  more  systematic  registration  of  businesses,  which  should  allow  competent 
authorities to better plan inspections and controls for all relevant companies.  

5.2.  Efficiency 

Q3. What are the quantifiable benefits, taking into account resources (cost, time, etc.) to 
stakeholders, including: 

  Consumers (e.g. health benefits); 
  Businesses,  including  specifically  for  SMEs  and  microbusinesses  (e.g.  in 

demonstrating compliance, market access); 

  Member States' competent authorities (e.g. in ensuring safety and control 

of FCMs)? 

5.2.1.  Human health benefits 
There is some available literature supporting adverse health effects from exposure to a limited 
number of hazardous substances that have been found to migrate from FCMs, for which rules 
have been introduced, such as  phthalates. However,  these adverse health effects  occur  from 
long-term exposure, where exposure also occurs from other sources such as environmental or 
other  consumer  products  and  where  other  interventions  may  have  occurred.  This  makes  it 
impossible  to  directly  link  possible  health  benefits  of  specifically  regulating  FCMs  and  to 
quantify the overall health benefits of the FCM Regulation.  

However,  an  attempt  has  been  made  to  estimate  the  magnitude  of  some  plausible  health 
benefits  from  a  limited  number  of  substances  regulated  under  FCM  legislation  for  which 
information  is  available.  FCMs  are  known  to  be  a  contributing  source  and  even  where  the 
contribution  from  FCMs  to  overall  exposure  is  assumed  to  be  very  small  (~1%),  the 
magnitude  of  health  cost  benefits  for  these  substances  is  likely  to  run  into  hundreds  of 
millions of euros. Based on reasonable assumptions, the same estimations may be applied for 
a  number  of  other  substances  that  migrate  from  FCMs,  although  the  extent  of  the  health 
benefits  will  vary,  and  many  will  have  less  hazardous  properties  or  migrate  in  smaller 
amounts resulting in lower exposure. 

Lead has long been used in ceramic ware, both in glazes and in decorations. However, it is a 
toxic substance that can cause a wide range of diseases, affects reproduction and the nervous 
system, as well as the (cognitive) development of children.92 A study from 2013 estimates that 
the  health  costs  caused  by  exposure  to  lead  amount  to  some  USD  970  billion  (EUR  820 
billion) annually in  low  and middle-income  countries (LMIC),  compared  to  USD 55 billion 
(EUR  45  billion)  in  Europe93.  This  translates  to  approx.  USD  170  (EUR  144)  per  capita  in 
LMIC,  compared  to  less  than  USD  110  (EUR  93)  in  Europe.  The  differences  between  the 
costs attributed to stricter legislation in the EU, extrapolating the per capita difference to the 
EU population, overall implies health benefits stemming from EU legislation of approx. USD 
31 billion (EUR 26 billion) per year.  

92 https://wedocs.unep.org/bitstream/handle/20.500.11822/27635/LeadRev.pdf  
93 Attina/Trasande (2013), Economic Costs of Childhood Lead Exposure in Low- and Middle-Income Countries, 
Environmental Health Perspectives 121(9). 

28 

 
                                                 
 
Human  exposure  occurs  mainly  via  food  and  water,  with  minor  amounts  via  air,  dust  and 
soil94.  Although  a  significant  proportion  of  exposure  via  food  is  likely  to  occur  due  to 
environmental contamination, it is known that lead can migrate in high amounts from ceramic 
ware  and  EU  legislation  exists  setting  limits  on  the  amount  of  lead  that  may  migrate  from 
ceramic FCMs. An estimate of the exposure to lead from FCMs accounting for around 1% of 
total exposure was considered reasonable, which in turn would equate to approximately USD 
310 million, or EUR 285 million per year in cost savings from the legislation. This indicates 
that the health benefits from restricting lead in FCMs could range in the hundreds of millions 
of euros, particularly over the period since the rules were introduced.  

Phthalates  have  long  been  used  as  softeners  or  plasticisers  in  plastic.  The  study  on  the 
cumulative  health  and  environmental  benefits  of  chemical  legislation  estimates  that 
restrictions  on  phthalates  resulted  in  benefits  for  reproductive  health  of  approx.  EUR  130 
billion  between  1996  and  2008  cumulatively,  or  about  EUR  11  billion  annually95.  These 
values are based on the lower bound reported by the study. While the study was not able to 
establish a causal relationship, the authors note that the reduction in health costs from diseases 
possibly caused by exposure to phthalates occurred at the same time as increased regulatory 
activity. Given that FCMs are one significant source of exposure of consumers to phthalates, 
it  is  likely  that  a  significant  share  of  the  benefits  reported  above  can  be  traced  back  to 
restrictions on the use of the substances in FCMs. For example, even if legislation on FCMs 
contributed only 1% to the estimated health benefits, this would imply health benefits of about 
EUR 110 million annually for this group of substances. 

A  report  published  recently  by  ECHA  on  the  costs  and  benefits  of  REACH  restrictions 
proposed between 2016 and 202096 also gives clues as to the possible impact of restrictions for 
the same substances restricted in FCMs, even if the restrictions are not comparable. Three of 
the four phthalates restricted under REACH are also restricted, albeit to a lesser extent, by the 
FCM  plastics  Regulation.  According  to  the  ECHA  report,  monetised  benefits  of  restricting 
bis(2-ethylhexyl)  phthalate  (DEHP),  dibutyl  phthalate  (DBP),  benzyl  butyl  phthalate  (BBP) 
and diisobutyl phthalate (DIBP) (the four phthalates) are estimated to outweigh the costs by 
more than 10 times. The benefits are estimated at EUR 235 million while the costs are about 
EUR 17.6 million per year in the worst-case scenario. 

Vinyl  chloride  monomer  (VCM)  is  produced  industrially,  primarily  to  make  polyvinyl 
chloride (PVC); PVC is used to make a variety of plastic products, including pipes, wire and 
cable  coatings,  and  packaging  materials.  Exposure  to  VCM  is  associated  with  an  increased 
risk of a rare form of liver cancer (hepatic angiosarcoma), as well as brain and lung cancers, 
lymphoma, and  leukaemia.  In the mid-1970s, VCM  was also  identified  as  a contaminant of 
foods packaged in PVC material97. In 1978, the EU introduced a restriction on the presence of 
vinyl chloride monomer in, and possible migration from, FCMs prepared with vinyl chloride 
polymers or copolymers. In turn, more stringent manufacturing specifications for PVC were 

94 https://doi.org/10.2903/j.efsa.2010.1570  
95 Commission (2017), Study on the cumulative health and environmental benefits of chemical legislation, p.114ff. 
96 https://echa.europa.eu/documents/10162/13630/costs_benefits_reach_restrictions_2020_en.pdf  
97  Rösli,  M.  et  al.  Rückstände  von  Vinylchlorid-Monomer  in  Speiseölen  [Residues  of  vinyl  chloride  in  edible  oils]. 
Mitteilungen aus der Gebiete der Lebensmitteluntersuchung und Hygiene, 66: 507-511 (1975). 

29 

 
                                                 
 
implemented and such contamination decreased substantially; as a result, VCM has not been 
identified in food, pharmaceuticals or cosmetic products in recent years98.  
Whilst  it  is  not  possible  to  quantify  the  health  savings  from  the  EU  intervention,  a  report 
prepared  for  the  Commission  in  2011  on  possible  impacts  of  amending  EU  legislation  on 
VCM for workers, indicates that health savings run into hundreds of millions of euros. Whilst 
the risks to workers are greater than they are to the average consumers, workers represent a 
sub-section of the population, whereas all EU citizens are consumers who may otherwise have 
been  exposed  to  VCM  from  food  packaging  over  the  years  subsequent  to  when  the  EU 
intervention was introduced. Therefore, a reasonable assumption is that restrictions on VCM 
may also have resulted in health savings of hundreds of millions of euros in the last 40 years. 

Prevention, control and reaction in Member States 
To  estimate  the  health  benefits  in  a  semi-quantitative  way,  a  composite  index  was 
developed99.  This  index  is  based  on  three  factors,  which  are  considered  to  contribute  to  the 
protection of consumer health in Member States: prevention, controls, and reaction. Further, 
table 5 in annex 5 reports on the results of the analysis.  

The  score  for  prevention  is  based  on  the  share  of  FCMs  covered  by  national  legislation 
(excluding harmonised materials). The results indicate that 14 out of 25 countries have a good 
overall  score,  meaning  that  they  got  at  least  70%  of  the  potential  weighted  score,  while  12 
countries received an overall weighted score of below 70%. However, for some of them the 
information available is very limited. Data availability was too limited for three countries to 
yield  meaningful  results.  The  analysis  found  a  good  weighted  score  for  five  countries  only, 
reflecting those with measures in place covering many material types. These scores are likely 
to be conservative, as they do not account for the potential contribution of one Member States 
rules to another.  

The  control  score  captures  whether  Member  States  have  the  resources,  expertise,  analytical 
equipment  and  procedures  in  place  to  perform  sufficient  controls.  Scores  are  mixed,  with 
good  scores  in  just  above  half  of  Member  States,  suggesting  that  the  benefits  yielded  from 
controls  remain  limited,  at  least  in  some  countries.  A  common  obstacle  pointed  out  across 
audit  reports  is  the  limited  number  of  controls  performed  each  year.  In  addition,  inspectors 
often lack adequate training to perform controls.  

The  reaction  scores  indicate  that  there  are  good  structures  in  place  in  all  Member  States 
except one, which enables them to react swiftly to RASFF notifications, all notifications are 
answered,  and  sanctions  are  applied  that  should  motivate  compliance  with  the  legislation. 
These aspects provide benefits for consumers by ensuring the protection of human health, and 
non-compliant FCMs will be quickly removed from the market. 

Overall,  the  exercise  indicates  that  health  benefits  stemming  from  the  EU  Regulation  on 
FCMs are not maximised. 

98 WHO (1999) Vinyl Chloride (Environmental Health Criteria 215), Geneva, World Health Organization 
99 Ecorys report, Annex 4 Methodological Annexes - Composite Index 

30 

 
                                                 
 
5.2.2.  Economic benefits for consumers  
The  harmonisation  of  rules  under  the  FCM  Regulation  and  subsequent  material-specific 
legislation  likely  yields  economic  benefits  for  consumers  too.  Harmonisation  should  reduce 
barriers to trade within the EU and, consequently, lower production prices for packaging and 
other  FCMs.  This  may  translate  into  lower  prices  for  consumers.  While  the  cost  and  price 
reduction are likely to be very small for an individual product, they may account for a sizeable 
sum when aggregated at EU level. An attempt was made by the contractor to collect evidence 
to indicate a positive (or negative) effect of the FCM legislation on consumer prices, but none 
could be found. 

5.2.3.  Benefits for businesses 
The public consultation40 results showed that difficulties in placing FCMs on the EU market 
appear  far  less  frequent  for  FCMs  subject  to  specific  EU  measures  (plastic  FCMs)  than  for 
FCMs  that  are  not,  indicating  that  further  harmonisation  of  FCM  legislation  has  a  positive 
effect  on  intra-EU  trade.  Similarly,  about  two-thirds  of  respondents  to  the  SME  survey100 
indicate  that  further  harmonisation  would  enhance  the  functioning  of  the  internal  market. 
Furthermore, trade data was examined and showed a correlation between the introduction of 
EU rules on plastic FCMs and an increase in intra-EU trade101, although no firm conclusions 
can be drawn since factors other than the legislation might also affect trade at the same time 
as  the  legislation  was  introduced,  such  as  demand  and  economic  viability  of  manufacturing 
plastic. 

Harmonised risk assessment work at EU level has also saved industry costs, which have been 
estimated by the number of times the application would need to have been filed with Member 
States.  Based  on  the  JRC  ‘baseline’  study7,  an  average  of  3.7  Member  States  perform  risk 
assessments per material group102. The administrative costs to prepare a dossier are estimated 
to  be  approximately  EUR  60  000  per  dossier  on  average103,  taking  into  account  its 
preparation, translation, etc. These are taken as the basis to estimate cost savings.  

Table 6 in annex 5 illustrates total costs savings for the 95 dossiers assessed at EU level by 
EFSA  between  2014  and  2018.  This  shows  that  total  cost  savings  could  be  anywhere  up  to 
EUR 15.4 million or EUR 162 000 per dossier. This does not take into account the costs for 
scientific work required for the assessment, which are several folds higher. It is assumed that 
applicants would be able to re-use the toxicity studies and analytical testing, although in some 
cases additional tests or criteria may need to be fulfilled. Member States have in some cases 
diverging  requirements,  which  also  results  in  re-doing  studies  or  generating  new  ones.  The 
true savings for a harmonised EU system may therefore be much greater. 

Further cost savings have been identified insofar as the Union list of authorised substances is 
not applicant specific and reduces the costs for businesses as they can use substances without 
generating risk assessment data and submitting applications of their own. As discussed in one 

100  Ecorys  report,  SME panel  consultation: 25  February  2019  –  20 April  2019.  Factual  summary  report  of  the SME Panel 

questionnaire: https://ec.europa.eu/food/system/files/2019-07/cs_fcm_20190616_summary-report-sme-panel.pdf  

101 Source: Ecorys based on Eurostat data  
102 Ecorys calculations based on JRC ‘baseline’ study. 
103 Source: Ecorys based on assessment of costs provided for EQ4 

31 

 
                                                 
 
of  the  focus  groups  of  the  evaluation,  this  is  particularly  important  for  SMEs  as  they 
otherwise lack resources to determine compliance without such legal certainty, compared with 
larger industry players.  

Evidence also  remains  inconclusive when the analysis is  undertaken  at  the country-level.  In 
September 2017, the German BfR published new recommendations on paper based FCMs104. 
This  “intervention”  was  used  to  explore  imports  of  paper  based  FCMs  into  Germany  from 
other EU countries in the months before and after the publication of these recommendations. 
However, it was not possible to identify a clear effect on the trade of these products.  

Overall, cost savings from the EU legislation are limited and relate to the existence of specific 
measures, in particular for plastic FCMs. 

5.2.4.  Benefits for Member States’ competent authorities 
According to EFSA, it spends an average of around EUR 430 000 to EUR 450 000 per year 
on risk assessments105. This covers the three categories of FCMs for which risk assessments 
are  currently  actively  performed  at  EU  level  (and  for  which  authorisation  is  required  or 
foreseen – plastic, recycled plastic and AIM). Three scenarios and estimates are provided in 
table  7  in  annex  5  and  from  this,  estimates  suggest  that  cost  savings  from  harmonised  risk 
assessments  range between EUR 450 000 and EUR 1.2 million  per  year for  Member States 
who otherwise undertake their own risk assessment work.  

The harmonisation of provisions on FCMs at EU level requires cooperation and exchange of 
information among competent authorities in the Member States. For example, authorities meet 
regularly  in  the  scope  of  PAFF  meetings  to  exchange  views  and  direct  risk  management 
actions.  The  EURL-FCM  contributes  to  the  improvement  and  harmonisation  of  methods  of 
analysis through its network with national reference laboratories. However, it is not possible 
to  quantify  or  even  monetise  the  benefits  of  this  enhanced  cooperation  and  knowledge 
sharing. Among others, the following organisations facilitate exchange and cooperation: 

  ESCO: The EFSA Scientific Cooperation working group is composed of experts from a 
selected  number  of  Member  States.  The  EFSA  Scientific  Cooperation  working  group 
supports the collection of information on non-harmonised FCMs across the EU; 

  FCM network: The Scientific Network on Food Contact Materials is a permanent group 
of  representatives  of  Member  States.  EFSA  oversees  the  organisation  of  the  group.  It 
comprises  all  Member  States,  as  well  as  the  Commission  including  the  JRC  (EURL-
FCM), Council of Europe, with EEA countries as observers. 

Overall,  cost  savings  for  Member  States  from  harmonised  risk  assessment  currently  appear 
limited. 

Q4. What are the quantifiable burdens, taking into account resources (cost, time, etc.) to 
stakeholders and are there aspects that could be simplified to improve efficiency? 

104 https://bfr.ble.de/kse/faces/resources/pdf/360.pdf. 
105 Ecorys report, interviews with stakeholders 

32 

 
                                                 
 
5.2.5.  Burdens for stakeholders 
The  estimate  from  this  evaluation  suggests  annual  costs  to  industry  linked  with  the  FCM 
legislation  in  the  region  of  EUR  3.1  billion  per  year  (or  around  3%  of  turnover)106.  This  is 
detailed further in table 8 in annex 5. The dimension of costs varies greatly depending on the 
position  of  businesses  in  the  value  chain  and  the  type  of  the  material.  Based  on  the  input 
received  from  stakeholders40,104  and  previous  research,  the  cost  items  were  grouped  and 
categorised  in  line  with  the  framework  developed  in  the  Commission’s  better  regulation 
toolbox107. Two types of costs are considered in the analysis: (1) compliance costs, including 
testing,  which  are  borne  principally  by 
dossier  preparation,  GMP,  and  analytical 
manufacturers and convertors and (2) administrative costs.  

It  should  be  noted  that  compliance  and  administrative  costs  here  are  assumed  to  be  linked 
with the FCM legislation. However, the business-as-usual (BAU) factor, which describes the 
share  of  activities  that  companies  would  have  performed  (and  thus  costs  they  would  incur) 
even if the EU legislation on FCMs had not been introduced, is likely to account for some of 
this. Certain  activities and production standards are desirable for companies anyway, due to 
self-regulation  in  the  sector  and  because  business  partners  along  the  value  chain  ask  for 
certain  information.  For  example,  even  though  DoCs  are  not  mandatory  for  FCMs  without 
specific  EU  measures,  several  industry  associations  developed  similar  documents  for  their 
sectors to ensure transparency and the information flow along the value chain.  

Plastics FCM industry 

Overall,  estimates  developed  during  the  evaluation  suggest  that  the  total  costs  of  the  FCM 
legislation  for  the  plastics  sector  amount  to  0.2%  to  2.9%  of  the  sector’s  turnover106.  An 
interview  with  representatives  of  the  sector  supports  the  upper  bound,  reporting  costs 
amounting  to  3%  to  4%  of  turnover,  or  in  the  region  of  EUR  1  billion. Table  9  in  annex  5 
illustrates the overall estimated costs for the plastics sector. Specifically for compliance costs, 
the  upper  bound  estimate  is  in  the  region  of  EUR  650  million  annually,  which  represents 
around 2% of the turnover. An interview with industry representatives to discuss the estimates 
suggests that the actual value is indeed likely to be closer to the upper bound.  

Table 10 in annex 5 reports specifically on the cost estimates for dossier preparation, which 
were collected from different sources for triangulation. PlasticsEurope provided cost estimates 
ranging  between  EUR  200  000  and  almost  EUR  2.2  million  for  a  dossier,  including  the 
administrative  costs  to  prepare  a  dossier.  This  correlates  with  the  findings  of  the  REFIT 
Evaluation  of  the  General  Food  Law35.  The  association  also  provided  a breakdown  of  costs 
among  the  key  cost  items  of  dossiers  –  toxicity  testing,  analytical  testing,  and  additional 
resources.  This  breakdown  suggests  that  toxicological  tests  are  the  key  cost  driver  but  vary 
significantly  depending  on  the  degree  of  testing  required,  with  requirements  and  thus  costs 
increasing  the  more  a  substance  is  likely  to  migrate.  The  costs  reported  by  industry  are 
generally  supported  by  other  estimation  techniques,  except  for  case  study  1  (see  annex  2), 
which used older cost estimates.  

106 Ecorys report, Annex 3 Methodological Annex and Quantification of costs 
107 
regulation-guidelines-and-toolbox/better-regulation-toolbox-0_en  

https://ec.europa.eu/info/law/law-making-process/planning-and-proposing-law/better-regulation-why-and-how/better-

33 

 
                                                 
 
From  when  the  plastics  Regulation  entered  into  force  until  2019,  97  applications  for  the 
authorisation  of  substances  have  been  received  for  substances  specifically  to  be  used  in 
plastic108. This equates to approximately 12 dossiers per year and therefore between EUR 2.4 
million  and  EUR  26.4  million  per  year  on  dossiers.  On  average,  this  equates  to  EUR  14.4 
million per year. 
According  to  the  SME  Panel  questionnaire100,  the  majority  of  SMEs  do  not  have  sufficient 
resources to apply for authorisation of a new substance in plastic FCMs. Not surprisingly, the 
SME panel questionnaire results show that the smaller the size of the enterprise, the lower the 
resources to  prepare applications. A review of the EFSA  register of  questions shows that in 
the  plastics  sector,  only  a  small  fraction  of  all  applications  is  submitted  by  SMEs  -  out  of 
approximately  100  applications  since  2011,  only  two  (in  2018)  have  been  identified  to  be 
submitted by SMEs.  

Establishing GMP and analytical testing account for the largest share of compliance costs for 
producers of plastic FCMs. The evaluation has estimated that these two cost elements account 
for  69%  to  72%  of  overall  costs.  Within  the  scope  of  case  study  3  (see  annex  2),  16 
companies provided detailed information on the costs linked to the FCM legislation and cost 
estimates  for  industry  were  based  on  these.  Table  11  in  annex  5  presents  the  costs  per 
company and its size, differentiating between a minimum, average, and maximum amount. In 
total,  estimates  suggest  annual  costs  of  EUR  54  million  to  more  than  EUR  280  million  for 
establishing  GMP,  and  some  EUR  93  million  to  almost  EUR  350  million  for  analytical 
testing. As mentioned before, interviews with the industry suggest that the actual annual costs 
are likely to be close to  the maximum estimated above, suggesting total costs close to EUR 
630 million for industry per year.  

In the case of the FCM legislation, key administrative cost items are the cost for producing a 
DoC  and  SD.  Companies  employ  between  0.1  and  6  full-time  equivalents  (FTEs)106  on 
administrative tasks linked to reporting requirements. The number depends on the size of the 
company.  Table  12  in  annex  5  reports  on  the  minimum  and  maximum  number  of  FTEs 
employed per company, broken down by company size. As for the compliance costs, numbers 
for  small  businesses  had  to  be  extrapolated  based  on  information  available  for  medium  and 
large companies. Using a weighted average109, these estimates can be translated into costs for 
companies.  This  suggests that administrative costs range between  a minimum  of EUR 3600 
per  year for a small  company  and a maximum  of almost  EUR 215  000 per  year for a large 
company. This translates into total annual costs ranging between EUR 59 million and close to 
EUR  230  million.  In  relative  terms,  administrative  costs  stemming  from  FCM  legislation 
account for less than 1% of turnover. They account for about a quarter of the overall costs of 
the FCM legislation for the plastics sector. 

According to the plastics industry (direct correspondence with the Commission), the duration 
of  the  process  of  risk  assessment  and  moreover,  risk  management  in  the  authorisation  of 
substances  leads  to  lost  market  time.  This  is  significant  given  the  investment  it  puts  into 
dossiers. It points to long periods of time in particular in the inclusion of new monomers and 

108 Between 2011 and 2018, based on EFSA Register of Questions, retrieved on 21/05/2019. 
109 Average labour costs in industry, weighted by the distribution of plastic packaging producers in the EU-28.  

34 

 
                                                 
 
additives in the Union list, which is often in contrast with the time taken to market substances 
on the US market.  

Non-plastic FCM industry 
The evaluation  examined burdens to  industry sectors not  subject  to  specific harmonised EU 
measures  to  compare  with  the  impact  of  EU-specific  rules.  Table  8  in  annex  5  gives  an 
overview of these costs compared with the plastics industry. Information was mostly available 
on  compliance  costs,  which,  like  the  plastics  sector,  appear  to  account  for  up  to  2%  of 
turnover for many sectors. However, depending on the sector concerned, there appears to be 
some variation, which is likely to reflect presence or absence of national requirements.  

For  certain  sectors,  companies  do  not  have  to  produce  a  DoC  for  their  products  or  are  not 
subject to specific testing requirements, which may reduce costs. On the other hand, resources 
spent  on  compliance  costs  for  certain  sectors  including  metals  and  alloys  (5%  of  turnover), 
paper and board (4%) and printing inks (10%) are considerably higher. It was not possible to 
gather data to elaborate in detail on why these sectors’ costs are so high but are likely in part 
to relate to multiple national requirements, and three examples are given below. Additionally, 
industry  confirmed  that  while  certain  costs  are  easily  quantifiable  (such  as  testing  and 
dedicated  human  resources),  other  costs  are  unpredictable,  making  their  assessment 
complicated.  Such  costs  mainly  relate  to  market  and  development  opportunities  that  are 
missed  in  EU  Member  States’  markets  with  different  national  legislation,  or  when  entering 
competition with harmonised materials (especially plastics). 

Rubber FCM industry 
According to national legislation, approximately the same number of substances are registered 
and used as for plastic (~900), which makes for a useful comparison. According to industry, 
diverging individual national approval schemes, containing a list of safety requirements and 
related tests to be applied to the final FCM article, increase costs110. It argues that the lack of a 
homogeneous approval scheme and positive lists, in combination with the absence of mutual 
recognition across Member States, is also creating an unjustified burden for companies, most 
of  which  are  SMEs.  Costs  for  certifying  product  conformity  or  authorising  the  use  of  new 
substances  are,  according  to  them,  multiplied  for  each  country  where  products  are 
commercialized.  The  cost  for  certifying  a  single  product  is  at  least  EUR  5000.  Whereas  an 
inventory  of  existing  “positive  lists”  of  monomers  and  other  compounding  ingredients  for 
rubber  FCM  from  the  Council  of  Europe  Resolution  on  rubber  products111  exists,  it  has  not 
been  implemented  by  most  EU  Member  States,  perhaps  providing  a  lost  opportunity  for 
reducing costs. 

Using  the  example  from  table  13  in  annex  5,  zinc  di(benzothiazol-2-yl)  disulphide,  the 
estimated costs from administrative preparation of the dossier for authorising the substance is 
EUR 60 000 in four Member States which equals EUR 240 000 compared with EUR 60 000 
for one single dossier preparation at EU level. Therefore, the additional cost incurred is EUR 
180 000. It is not known for any of these substances what additional costs may have incurred 

110 Resolution AP (2004) 4 on rubber products intended to come into contact with foodstuffs. 
111  https://www.edqm.eu/sites/default/files/policy_statement_concerning_rubber_product_products_intended_to_come_into_ 
contact_with_foodstuffs_v1_june_2004.pdf  

35 

 
                                                 
 
for different  studies  or data and testing requirements across the four Member States, and so 
the additional costs to the rubber industry may be significantly higher.  

FCM printing inks 
Germany  has  recently  prepared  legislation  to  introduce  a  positive  list  for  inks112.  In  the 
accompanying impact assessment (page 90 onwards of the draft), it explores the effects and 
costs of the ordinance on authorities, as well as industry. It is estimated that the introduction 
of the ordinance would create costs of about EUR 18 million for the inks industry in Germany 
(EUR 900 000 per company) as one-off costs, with another EUR 2 million (EUR 100 000 per 
company) in ongoing or annual costs. Based on the input from the ink industry in Germany, 
authorisation processes can be expected to add another EUR 2 million per year. Costs for the 
whole value chain are estimated to be significantly higher, at about EUR 660 million one-off 
costs  for  the  implementation  of  the  ordinance.  The  impact  assessment  does  not  provide  an 
estimate of the recurrent costs for the whole value chain nor the costs if printing inks would 
be regulated at EU level. Industry has argued that the legislation is disproportionate, increases 
barriers to the commercial success of innovation and drives up consumer prices, which is not 
supportive of on-going economic recovery113. 

Safeguard measures on BPA 
The use of BPA in food and beverage cans is particularly significant, as the majority of cans 
(around 80%) utilise the BPA based epoxy-resin technology as a coating. Around 50 billion 
beverage cans and 20 billion food cans are produced in the EU each year; in the latter case, 
the  estimated  value  of  this  market  in  2010  was  EUR  30  billion  in  the  EU.  Specific 
requirements laid down by the safeguard measures adopted by French legislation have had a 
knock-on  impact  throughout  the  EU  and  in  wider  Europe  since  production  and  distribution 
methods have been developed for the EU market as a whole. Costs derive not only from the 
research  and  development  time  of  either  replacement  substances  or  alternative  packaging 
materials, but also as a consequence of reformulation, testing, trial periods before marketing 
and  questions  over  the  effectiveness  of  replacements,  leading  to  possible  food  waste  and 
therefore additional costs. Overall costs to industry are high and in 2015, industry estimated 
such costs at up to EUR 1.5 billion114.  

Burdens on SMEs 

Almost a third of SMEs report that costs linked to the FCM legislation are not proportionate 
to  the  size  of  companies,  whereas  a  fifth  of  respondents  to  the  SME  survey100  state  the 
opposite.  Companies  did  not  provide  a  reasoning  for  this  judgement.  However,  there  are 
certainly  costs  that  are  independent  of  the  size  of  the  business.  The  tests  and  evidence 
companies  must  produce  is  independent  of  the  size  of  the  company.  As  a  result,  these 
requirements can be particularly burdensome for smaller businesses.  

SMEs  heavily  rely  on  associations  and  service  providers  to  get  them  the  information  they 
need  as  they  do  not  have  internal  resources  with  knowledge  of  national  systems  across  EU 

112  Einundzwanzigsten  Verordnung  zur  Änderung  der  Bedarfsgegenständeverordnung  vom  2.  Dezember  2021 (BGBl.  I  S. 
5068)  
113 Stakeholder correspondence to DG SANTE, 2018 
114 Stakeholder correspondence to DG SANTE, 2015 

36 

 
                                                 
 
Member  States.  As  discussed  with  industry  representatives,  the  specific  consequences  for 
SMEs  in  monetary  terms  cannot  be  measured,  but  SMEs  may  not  be  able  to  understand  or 
afford to meet the different requirements in national laws, which means they can be excluded 
from  markets.  The  costs  of  additional  testing  are  a  burden,  especially  for  small  companies 
which cannot absorb such costs, or they simply have to decide where to sell in advance and 
test  accordingly,  which  is  restricting  their  access  to  the  internal  market.  Case  example  6  in 
annex 6 highlights some practical issues.  

Overall,  costs  to  industry  are  estimated  to  be  around  3%  of  the  total  turnover,  with  the 
majority of those costs spent on compliance (~2%) and a smaller proportion (~1%) spent on 
administrative costs. For certain sectors where there are no EU-specific measures, costs may 
be  even  higher  (up  to  10%).  Safeguard  measures  adopted  by  Member  States  pursuant  to 
Article 18 of the FCM  Regulation or other unilateral  action can significantly increase costs. 
Costs  for  SMEs  may  be  proportionality  higher  where  the  same  requirements  exist;  national 
measures are even more burdensome.  

Burdens on Member States 
Overall, cost estimates for Member States are reported in table 14 in annex 5, although there 
were  significant  data  gaps  and  large  variations  in  the  costs  between  Member  States.  On 
average, each Member State spends between EUR 500 000 and 800 000 per annum on FCMs. 
The majority of costs come from controls, including both costs for FTEs and budget allocated 
to control activities in Member States. Resources spent on controls generally increase with the 
size  of  a  country’s  population,  which  would  be  expected,  with  the  majority  being  costs  for 
resources such as physical sampling and analysis, and costs for staff contributing around one-
third. 

Competent  authorities  incur  costs  of  about  EUR  2.4  million  to  EUR  3.2  million  in 
implementing harmonised (EU) legislation each year, about half of which are estimated to be 
staff  costs.  These  numbers  are  estimates,  based  on  the  information  from  interviews  with 
Member  States  and  the  JRC  ‘baseline’  study7,  which  together  covered  about  half  of  the 
Member  States.  Estimates  suggest  that  in  total  about  36  to  39  FTEs  work  on  the 
implementation  of  harmonised  legislation  in  Member  States  (about  1.4  FTE  per  Member 
State).  This  varies  depending  on  the  Member  State,  which  perhaps  reflects  their  priority  on 
FCMs. Costs for Member States for the implementation of the national legislation on FCMs 
are  less  than  for  the  EU  legislation.  In  some  Member  States,  there  is  no  national  specific 
legislation and consequently, these Member States incur no such costs. Estimates suggest that 
there are about  20 to  24 FTEs working on the implementation  of national  legislation across 
the EU (just under 1 FTE per Member State).  

Burdens on EU institutions and agencies 

In  total,  EFSA  spent  about  EUR  3.4  million  between  2014  and  2019  on  FCM  related 
activities,  around  EUR  600  000  per  year  including  both  resources  for  risk  assessment  and 
costs for FTEs, which were on average just under  6 FTEs annually. This  does not  take into 
account  experts  and  members  of  the  Panel  on  Food  Contact  Materials,  Enzymes  and 

37 

 
Processing Aids  (CEP),  who contribute  with their scientific  expertise  to the risk assessment 
work. 

According to  its  register of  questions, EFSA has received 569 applications related to  FCMs 
since 2004115. This includes substances for plastic, AIM and recycling processes. At the time 
of the research, 430 applications have been completed with just over 100 either not accepted 
or withdrawn. On average, EFSA needs 392 days between acceptance of an application and 
the  adoption  of  an  opinion.  However,  EFSA  reaches  a  conclusion  in  less  than  300  days  in 
more  than  half  of  all  cases,  and  the  median  duration  is  280  days,  or  about  9.5  months. 
However, this is longer than the six months foreseen in the legislation, which may indicate the 
complexities of the risk assessment work, need to establish further information  or resources 
available to EFSA.  

On  average,  the  Commission  spends  around  EUR  2.3  million  per  year  on  tasks  related  to 
FCMs. This is based on costs calculated to be almost EUR 10 million  spent by DG SANTE 
since 2010. Of these costs, about EUR 5.7 million are attributable to FTEs who undertake risk 
management  of  the  legislation  and  policy  coordination,  and  the  remaining  EUR  4.3  million 
has been spent on other resources, including Better Training for Safer Food (BTSF) activities, 
external meetings, studies and audit work. An additional EUR 1.3 million per year is spent by 
the JRC on operational costs related to FCM technical work and support in the context of their 
work as the EURL-FCM, although this does not include the cost of new equipment.  

Q5.  Taking  into  account  the  answers  to  questions  3  and  4,  how  efficient  is  the  FCM 
Regulation and its implementation tools in ensuring the safety of FCMs? 

5.2.6.  Overall efficiency of the FCM Regulation 
Despite efforts to  gather relevant information for this evaluation, it has not been possible to 
quantify  health  benefits  stemming  from  the  EU  FCM  legislation.  Therefore,  no  comparison 
can be made with the estimated cost of the legislation to conclude on overall efficiency. The 
evaluation  has  looked  at  specific  examples  of  substances,  the  restrictions  of  which  may 
contribute  to  health  benefits  in  the  region  of  hundreds  of  millions  of  euros;  whereas  the 
overall cost of the legislation is estimated to be in the region of EUR 3 billion. This includes 
annual costs for competent authorities, EU institutions, and costs for industry.  

Hypothetically, if the same potential health benefits of regulating the substances analysed in 
this  evaluation  are  realised  for  all  regulated  substances,  the  monetary  value  of  the  health 
savings  is  likely  to  exceed  the  costs  of  the  legislation.  It  should  be  acknowledged  that  the 
substances for which estimates of health benefits are given in this report are examples where 
adverse health effects of exposure to those substances are substantial and easily identifiable, 
e.g. lead, and the corresponding restriction is therefore likely to result in higher cost savings 
for  health.  Still,  even  if  the  health  savings  for  other  individual  substances  were  less 
substantial, the health benefits are overall still expected to exceed the costs. 

Efficiency  of  the  legislation  itself  is  difficult  to  estimate  because  not  all  actions  taken  are 
necessarily a result of the FCM Regulation. Self-regulation by industry is likely to have taken 
place even without the FCM Regulation; Member States are likely to have introduced national 

115 EFSA Register of Questions, as of 21/05/2019 

38 

 
                                                 
 
rules  even  without  Article  6  of  the  FCM  Regulation.  Therefore,  to  a  certain  extent,  actions 
taken by industry and Member States are likely to have contributed positively to cost savings 
for health, even in the absence of EU rules.  

For  some  sectors  for  which  there  are  no  EU-specific  rules,  the  cost  estimates  are  either  the 
same or less than for the plastics sector, i.e. compliance costs are estimated to amount to about 
2% of turnover. The glass and ceramics sectors are both  estimated to face compliance costs 
which  are  significantly  below  the  average  of  2%.  This  may  largely  be  explained  by  the 
approach both at EU level and national level, where relatively few substances are regulated, 
lowering the burden to industry of ensuring compliance.  

For other sectors such as paper and board, costs appear to be greater than for sectors for which 
EU-specific rules apply. As no additional health benefits can be attached to these extra costs, 
the  efficiency  for  these  sectors,  which  combine  the  general  requirements  of  the  FCM 
Regulation and national rules, appears less than the efficiency provided by EU-specific rules. 
Since certain stakeholders also consider that there is inadequate health protection for materials 
for which no specific rules exist, this inefficiency may be even greater.  

Although the evidence itself is not always clear, there are unanimous calls from industry for 
greater harmonisation of EU-specific rules across sectors beyond plastic. More than 9 out of 
10  respondents  to  the  public  consultation40  indicate  that  they  consider  harmonised  material 
specific  legislation  better  than  regulating  materials  at  a  national  level,  often  pointing  to 
efficiency  gains  for  industry.  There  is  clear  logic  that  greater  efficiency  comes  from  EU-
specific rules:  resources  spent  on  regulation  and  compliance ensure access to  the whole EU 
market and a high level of human health protection across the EU, following a thorough and 
transparent risk assessment from EFSA, with follow up risk management agreed across all EU 
Member  States.  It  avoids  potential  duplication  of  assessments,  legislation  and  testing  rules 
across different Member States. 

Other inefficiencies can be seen in the approach to regulating plastic FCMs. While significant 
resources are put into ensuring safety of the monomer or additive in its intended use in plastic, 
the same approach for other materials and the remaining 9000 additional substances used in 
FCMs  that  are  not  specifically  regulated  at  EU  level  is  impractical.  Based  on  current 
resources, EFSA is capable of processing between 25 and 50 applications for risk assessment 
each year with the current approach, depending on the complexity of the dossier. This implies 
that  with  current  resources,  EFSA  would  need  between  140  and  360  years  to  perform  risk 
assessments for all substances used in FCMs. This calculation does not  yet include time for 
the preparation of dossiers, risk management or the legislative process  to  establish the legal 
basis to perform risk assessments for all material groups. 

So far, plastic FCMs and RCF are the only materials for which authorised lists of substances 
exist at EU level. EFSA takes responsibility for the risk assessment of new applications, while 
the Commission is responsible for risk management in collaboration with Member States. The 
Union list in effect since 2011 is based on extended harmonisation efforts of the EU and the 
Member States in previous decades. The compilation of a Union list of substances authorised 
for use in the manufacture of plastic FCMs has taken more than 30 years, with the continued 
need to update and modify both the list and associated rules. As discussed in section 5.1, this 
represents only 10% of substances known to be used in the manufacture of all FCMs. 

Many  substances,  such  as  those  used  to  manufacture  polymers,  are  not  only  used  to  make 
plastic but also other materials such as synthetic rubbers, silicones and coatings. Whereas the 

39 

 
chemistry involved in production of the resulting polymer often differs as well as the potential 
for  migration  and  generation  of  NIAS,  the  toxicology  of  the  starting  substance  remains  the 
same. Yet, risk assessment and risk management of the same substances used in coatings are 
not in place at EU level. This raises questions on the efficiency of the approach of regulating 
plastics  alone  and  that  potential  health  benefits,  compared  with  the  costs,  are  not  fully 
realised.  

Another  inefficiency  has  also  been  identified  in  the  lack  of  prioritisation  of  substances. 
Whereas  the  authorised  list  approach  dictates  that  substances  used  to  manufacture  an  FCM 
must  first  be  assessed  and  authorised  before  they  are  used,  these  substances  may  in  fact  be 
more  benign  than  other  substances  for  which  either  an  EU  authorised  list  does  not  exist  or 
where they may be present anyway and migrate as NIAS.  

The current approach to the EU risk assessment dictated by EFSA recognises differences that 
may  exist  in  the  potential  risk  from  a  substance  due  to  its  migration  potential,  and  this  is 
reflected  proportionality  in  the  resources  and  efforts  required  to  generate  toxicology  data. 
However, resources at both the EU risk assessment and risk management level are focused on 
starting  substances  subject  to  an  authorised  list,  regardless  of  their  potential  hazardous 
properties,  rather  than  on  substances  with  known  hazardous  properties  that  may  be  present 
and potentially migrate into food.  

Compared with similar approaches to the risk assessment and risk management of chemicals 
in other EU legislation, the costs for industry for the risk assessment of plastics materials are 
low  compared  with  other  EU  legislation.  As  for  active  substances  used  in  plant  protection 
products,  companies  do  not  have  to  pay  a  fee  for  the  submission  of  dossiers  to  include 
substances in the positive list of plastic FCMs. In comparison to this, companies have to pay 
fees under REACH and the biocides Regulation (EU) No 528/2012116 (see table 1 below).  

The cost for preparing a dossier for biocides products is 6 to 10 times higher than for FCMs; 
the approval of an active substance for the use in plant protection products is up to 80 times 
higher than the dossier for substances to be used in plastic FCMs. Compared to the REACH 
registration  system,  costs  appear  higher  for  the  FCM  sector.  Including  application  fees,  an 
average  application  under  FCM  costs  about  30%  more  than  under  REACH.  Yet,  these 
comparisons need to be treated with caution. The complexity of dossiers and the tests required 
for each of them vary greatly across policy fields.  

However, it is noteworthy that almost all studies required for an application under the plastics 
Regulation  are  also  required  for  the  registration  of  substances  under  REACH.  Therefore,  in 
theory,  companies  would  not  have  to  redo  toxicological  studies  for  submissions  under  the 
FCM  legislation  if  the  substance  is  registered.  However,  in  an  interview,  industry 
representatives  pointed  out  that  this  is  not  necessarily  the  case.  In  particular,  an  applicant 
seeking the authorisation of a substance for the use in plastic materials needs to provide also 
tests and studies on potential impurities. However, the applicant usually does not have access 

116 http://data.europa.eu/eli/reg/2012/528/oj 

40 

 
                                                 
 
to  these  studies,  and  therefore  needs  to  reach  out  to  the  Substance  Information  Exchange 
Forum (SIEF)117, requesting access, and might have to redo a study if access is not granted.  

Table 1: Comparison of costs for industry for the inclusion of substances in positive 
lists 

Application 
costs 

Regulation on 
plastic FCMs 

Plant protection 
products118,119 

Fees (EUR) 

0 

0 

500,000 

2,000,000 to 
40,000,000 

Dossier 
preparation 
(EUR) 

5.3.  Relevance 

Biocide 
products120 

50,000 – 
150,000121 
3,000,000 to 
5,000,000 

REACH 

1,739 – 
33,699122 
153,195123 

Q6.  What  are  the  needs,  interests  and  expectations  of  (a)  consumers  and  their 
representative  organisations;  (b)  businesses  including  food  businesses  and  (c)  Member 
States’  competent  authorities  and  to  what  extent  does  the  current  legislation  address 
them? 
Over  the  last  decade  or  so,  consumers’  relationship  with  food  appears  to  have  shifted,  with 
concerns  that  food  should  be  safe  taking  an  increasingly  important  role.  A  2005 
Eurobarometer124  survey  showed  that  consumers  associated  food  mainly  with  taste  and 
concerns  over  food  health  risks  were  low  (11%).  However,  a  Eurobarometer  held  in  2019 
showed in addition to taste, food safety was among the most important factors for European 
consumers.  Consumers  are  also  increasingly  concerned  about  the  effect  of  chemicals  on 
health. The same Eurobarometer survey in 2019 revealed that EU citizens are aware of issues 
potentially related to FCMs, with around half of the respondents saying they have heard about 
traces of materials that come into contact with food (51%) and micro plastics found in food 
(48%).  Consumer  safety  concerns  are  reflected  in  the  willingness  to  accept  higher  prices  in 
order to have safer food packaging or kitchenware (66%).  

For consumers and consumer representatives, safety remains one of the first priorities when it 
comes  to  FCMs.  Replies  to  the  public  consultation40  shows  96%  of  consumers  consider  it 
very  important  that  FCMs  are  safe  and  chemical  substances  do  not  contaminate  the  food. 

117  http://www.sief-it.com/.  The  aim  of  SIEF  is  to  facilitate  the  exchange  of  information  between  potential  registrants 
necessary for the registration of the same substance in order to avoid duplication of studies and to agree on the classification 
and  labelling  (C&L)  of  the  substance.  The  SIEF  also  serves  as  a  platform  for  data  holders  to  share  their  substance 
data/studies.  Moreover,  when  the  available  information  is  not  sufficient  for  registration,  a  SIEF  collectively  identifies  the 
need for further studies 
118 European Commission (2018), Study supporting the REFIT Evaluation of the EU legislation on plant protection products 
and pesticides residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) 
119 Estimates reported for the application of approval of a new active substance 
120 COM(2009) 773 final 
121 COM(2018) 342 final. https://ec.europa.eu/health/sites/default/files/biocides/docs/com2018342_en.pdf  
122  http://data.europa.eu/eli/reg_impl/2015/864/oj  (depending  on  volume/type  of  submission  and  company  size,  with 
reductions for SMEs) 
123 European Commission 2017, Impacts of REACH Authorisation. Average dossier preparation includes registration fees 
124 https://www.gesis.org/en/eurobarometer-data-service/home  

41 

 
                                                 
 
Equally, 97% of EU citizens responding to the public consultation consider it important that 
FCMs  do  not  alter  the  taste,  texture  or  smell  of  food,  indicating  the  continued  relevance  of 
Article  3(1)(c)  of  the  FCM  Regulation.  The  public  consultation  showed  citizens  trust  the 
safety  of  FCMs  to  a  reasonable  (38%,  84  respondents)  or  to  a  large  extent  (35%,  76 
respondents), with 66% of EU citizens responding to the public consultation believing that the 
level of safety of food packaging sold in the EU has increased over the last 10 years. On the 
other  hand,  NGOs  raised  concerns  related  to  the  presence  and  migration  of  hazardous 
substances,  such  as  substances  of  very  high  concern  (SVHCs)  under  REACH,  CMRs, 
substances with endocrine disrupting properties (EDs), neurotoxic and NIAS substances and 
to  the  sustainability  (e.g.  disposal,  recycling,  reuse)  of  FCMs  as  consumer  waste  (e.g. 
packaging). 

Labelling is another important aspect that is specifically relevant for consumers’ needs as it 
enables  them  to  use  the  FCM  safely  and  appropriately.  However,  section  5.1  describes 
difficulties in the understanding of simple pictograms, including the wine glass and fork logo. 
Specific instructions for safe use also appear relevant but may be absent in situations where 
all  conditions  of  use  or  re-use  are  not  or  cannot  be  foreseen  by  the  FCM  business.  One 
example is the storage of hot or fatty foods in single-use ice cream containers, as confirmed 
by  public  consultation40  results  and  illustrated  in  the  2019  survey  undertaken  by  vzbz41, 
although  it  should  be  noted  that  this  does  not  necessarily  demonstrate  that  such  re-use  is 
unsafe.  

However, public authorities and business reiterated the difficulties of realistically assessing all 
possible uses and reporting them on the label – as demonstrated by the more novel practice of 
cooking whole beer cans together with hot, fatty foods. The practice has nevertheless become 
much  more  common  over  recent  years,  promoted  by  celebrity  chefs  with  hundreds  of 
‘recipes’ available online125.  

While  specific  needs  differ  depending  on  the  position  along  the  supply  chain,  overall,  the 
needs  of  businesses  have  not  changed  significantly  over  time.  Their  needs  relate  to  their 
ability being able to produce, sell and trade their products across the EU with minimal burden 
and  meeting  their  customers’  needs.  This  requires  clear  rules  and  guidance,  and  that 
information  along  the  supply  chain  is  exchanged  effectively  to  ensure  compliance  and  the 
safety of the final article or material. The JRC ‘baseline’ study7 demonstrates commonalities 
in  the  production  and  distribution  of  FCMs  on  the  EU  market  and  from  the  consultation 
activities and discussion in earlier sections, it is clear that the more harmonised rules are, the 
more  relevant  this  is  for  businesses.  Overall,  there  has  been  an  expectation  from  industry 
stakeholders that more EU-specific rules would follow those already introduced primarily for 
plastic FCMs. 

Although current specific EU rules are more relevant to business operators than more generic 
rules  or  diverging  specific  rules  between  Member  States,  they  appear  more  relevant  for 
businesses  at  the  start  of  the  supply  chain,  rather  than  convertors  or  manufacturers  of  final 
FCMs, including the majority of SMEs, because they are focussed on starting substances and 
lack more detail on intermediate and finished articles. This leaves a potential gap as regards 

125 https://www.simplyrecipes.com/recipes/beer_can_chicken/  

42 

 
                                                 
 
the  needs  of  actors  further  along  the  supply  chain  who  have  responsibility  for  intermediate 
and  final  materials.  For  example,  convertors  reported  problems  related  to  the  flow  of 
information and burdens due to the necessity to adapt and perform migration tests for multiple 
articles. In this sense, the specific EU rules are less relevant for actors further along the supply 
chain. 
Targeted consultation of 700 SMEs100 showed that assessing the needs of SMEs is difficult as 
the smaller the business gets, the less they are aware of FCM legislation, let alone what the 
requirements  and  their  responsibilities  are,  and  what  their  own  needs  might  be.  Although 
SMEs consider that the current FCM legislation places disproportionate burden on them, most 
SMEs  consulted  do  not  report  having  any  issues  to  market  or  sell  FCMs.  The  smaller  the 
business, the less burden they reported, with 67% of self-employed respondents reporting no 
burden at  all.  Overall, awareness  of the rules and ease of understanding  them appears to  be 
low for SMEs. 

Around  65-70%  of  responding  SMEs  replied  being  sufficiently  familiar  with  safety 
requirements under FCM legislation. This drops to below 50% for self-employed individuals. 
Most  SMEs  replied  being  fairly  familiar  with  basic  requirements  of  the  FCM  Regulation 
regarding safety, GMP,  labelling and traceability. Their degree of knowledge was lower for 
specific legislation and rules, and, in particular, on compliance documentation and migration 
limits (for plastics). This is not necessarily due directly to the legislation itself but indicates a 
possible  opportunity  to  address  better  the  needs  of  SMEs,  who  may  find  the  requirements 
simply too complex without further assistance. 

As with industry stakeholders, it is apparent from consultation activities such as case study 2 
(see  annex  2)  as  well  as  proactive  correspondence  to  the  Commission  that  Member  States 
desire further EU-specific rules for materials beyond mainly plastics and have anticipated this 
for several years. Enforcement of FCMs without specific EU rules is perceived as particularly 
challenging  and  controls  tent  to  be  lax  or  even  absent.  Member  States  may  rely  on  BfR 
Recommendations, other national legislation, resolutions from the Council of Europe or even 
US  legislation,  but  argue  that  it  is  difficult  to  enforce  based  on  recommendations  and 
resolutions, as they are not “hard legislation”. Where national legislation exists, it is difficult 
to access and use by inspectors, and it is often available only in national languages, whereas 
inspectors in particular require clear rules in the own language. A lack of controls also implies 
a  lack  of  findings  by  competent  authorities  and  a  failure  to  identify  potential  problems  and 
prioritise FCM controls, which ultimately has the potential to affect safety of FCMs. 

The capacity of Member States to enforce legislation based on physical sampling and analysis 
is limited; costs are high and methods are not readily available. Consequently, there is a need 
to  have  access  to  adequate  and  timely  information  on  compliance  undertaken  in  the  supply 
chain, including a DoC and SD. However, there are no requirements for DoC and SD are at 
EU level beyond specific materials including plastics, RCF and ceramics, and Member States 
or  industry  are  free  to  define  their  own  approaches,  which  can  vary  or  may  be  absent. 
According  to  Member  States’  experience,  compliance  documentation  is  often  lacking  or  at 
least not readily available on request. Stakeholders have repeatedly asked for a common DoC 

43 

 
and  SD  requirements  beyond  plastics,  including  a  specific  request  made  under  the 
Commission’s  REFIT  platform126  as  per  the  opinion  following  a  request  by  the  Danish 
Business Forum127.  

Audits  and  fact-finding  by  the  Commission  point  to  insufficient  training  on  controls, 
including those on documentation checks and implementation of GMP. Many Member States 
indicate a need for more capacity to train staff and interest and participation in BTSF training 
by  Member  States’  competent  authorities  continues  to  be  strong.  In  addition  to  this  gap  in 
expertise, there has been a lack of coordinated and systematic enforcement strategies with few 
exceptions. This has left Member States to prioritise controls individually, whereas problems 
are likely to be common across the EU, as demonstrated by the prevalence of non-compliant 
melamine  tableware  in  recent  years.  A  recent  exercise  to  coordinate  controls128  has  proved 
successful  and  well  received  by  Member  States,  indicating  further  scope  for  more 
coordination in the future. 

Q7.  To  what  extent  has  Regulation  (EC)  No  1935/2004  [the  FCM  Regulation]  and  its 
subsequent implementation allowed for evolving science, prioritisation and innovation? 

There are elements of the FCM Regulation and its implementation that have been supported 
by evolving scientific understanding. For example, the JRC in its capacity as EURL for FCMs 
provides  scientific  and  technical  assistance  to  the  Commission  and  the  Member  States.  It 
organises inter-laboratory comparison exercises and conducts training courses for the benefit 
of NRLs as well as experts from developing countries, helping them to apply new methods of 
analysis. It has developed guidelines for testing and compliance work, which ultimately help 
in  supporting  the  work  of  the  Member  States  on  controls  as  well  as  helping  to  keep 
requirements set on testing approaches in the EU up-to-date. Therefore, support exists in the 
implementation of the legislation as regards the development of analytical methodology. 

Similarly, part of EFSA’s mandate includes identifying emerging risks, including substances 
migrating from FCMs. An EFSA Scientific Cooperation (ESCO) Working Group was set up 
in  2010  in  order  to  collect  the  information  and  make  proposals  to  anticipate  emergency 
situations  linked  to  the  presence  of  substances  released  by  non-plastic  FCMs  in  food. 
Strategies  for  prioritisation  of  the  evaluations  of  substances  and  for  providing  preliminary 
advice in case of urgent need were proposed75, although to date no need has been identified. 
They  included toxicity and exposure assessment  tools, such as  read-across approaches from 
structural similar substances or approaches based on human exposure thresholds correlated to 
the chemical structure of the substance. Following this, a network of experts was set up129 to 
enhance collaboration between scientists involved in risk assessment of FCMs to support and 
harmonise risk assessment practices in this area and continues to date. 

The introduction of EU-specific measures focussing on the safety of substances used in AIM 
and to that ensure plastic FCMs are sufficiently decontaminated during recycling, reflected a 
growing use of AIM and recycling of plastic for food contact use. At the time, the approaches 

126 https://op.europa.eu/webpub/com/refit-scoreboard/en/policy/9/9-13.html  
127 https://ec.europa.eu/info/sites/default/files/opinion_health_food_1a.pdf  
128 http://data.europa.eu/eli/reco/2019/794/oj  
129 https://www.efsa.europa.eu/sites/default/files/assets/fipnonplasticsnetworktor.pdf  

44 

 
                                                 
 
used in the regulations were considered appropriate in order to protect consumers and address 
the needs of businesses. However, to date, neither the authorisation of substances assessed for 
use  in  AIM  nor  the  authorisation  of  processes  for  recycling  have  been  successfully 
implemented, whereas stakeholders have indicated in particular that the measure on recycled 
plastics is urgently needed to support the overall reduction in plastic waste. 

The  untimely  implementation  of  these  regulations  in  part  reflects  the  difficulties  in  keeping 
pace  with  evolving  science  and  has  raised  questions  on  the  practicalities  of  the  approaches 
originally foreseen. For AIM, EFSA has been evaluating AIM systems as a whole, whilst the 
regulation  requires  authorisation  of  individual  substances,  which  has  presented  a  significant 
difficulty in the implementation.  

Similarly,  the  initial  phase  of  risk  assessment  and  risk  management  for  the  authorisation  of 
processes  under  Commission  Regulation  (EC)  No  282/2008  has  focussed  on  recycling  of 
poly(ethylene  terephthalate)  (PET)  and  has  fallen  short  in  addressing  other  types  of  plastic, 
other materials or newer scientific technologies such as chemical recycling, leaving a gap in 
an ever-expanding market and to address evolving priorities130. These new types of recycling 
technologies  are  seen  as  key  to  providing  for  future  needs  and  challenges  that  cannot  be 
addressed altogether with more traditional, mechanical recycling.  

There is a growing interest among consumers in the impact our consumption patterns have on 
our environment, in particular on how we produce, consume and dispose of consumer goods 
and waste we produce131. Similarly, these concerns are reflected well in the results from the 
public  consultation40,  where  most  EU  citizens  considered  it  important  that  FCMs  are 
recyclable with minimum packaging as well as a general preference to see packaging that is 
reusable, biodegradable or made from “natural” materials. In turn, there is clear evidence that 
the  production  of  FCMs  and  in  particular  food  packaging,  is  evolving  with  new  and 
innovative types of material being used and introduced onto the market, including those that 
are  either  bio-based,  possess  more  biodegradable  properties  than  traditional  packaging 
materials132 or use nanomaterials133.  
Yet,  these trends are not well accommodated in  the current  FCM legislation, which favours 
risk assessment and risk management of well-established chemistry, with a focus on defined 
starting substances to produce synthetic polymers in order to manufacture plastics. While bio-
based polymers  are specifically  addressed under  the plastics Regulation,  there  are still clear 
gaps  for  materials  for  which  no  EU-specific  measures  have  or  even  can  be  introduced, 
including  biodegradable  materials.  These  gaps  must  be  filled  in  the  context  of  initiatives 
introduced under the European Green Deal134, including legislation on Single Use Plastics and 
Waste,  Packaging  and  Packaging  Waste  in  order  to  ensure  that  new  products  entering  the 
market  are  safe  for  consumers  to  use  as  well  as  being  more  sustainable  and  better  for  the 
environment. 

130 Ecorys report, annex 2: Case study 6 (based on focus group 6) “External coherence of the FCM legislation” 
131 2020 Eurobarometer on Attitudes of EU citizens towards the environment 
132 https://onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12715  
133 https://link.springer.com/article/10.1007/s13197-018-3266-z  
134 https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en  

45 

 
                                                 
 
As noted in section 5.1 on effectiveness and 5.4 on coherence, the current approach also fails 
to  sufficiently  prioritise  the  most  hazardous  substances,  rather  focussing  on  starting 
substances regardless of their hazard properties, whether they are present in or migrate from 
the  final  article  and  is  primarily  applicable  for  plastic  FCMs.  Information  generated  under 
REACH  legislation  and  hazard  assessments  done  under  Regulation  (EC)  No  1272/2008  on 
classification,  labelling  and  packaging  of  chemical  substances  and  mixtures135  (the  CLP 
Regulation),  for  example  remains  untapped,  whereas  in  reality  some  of  the  data  may  be 
relevant  to  use  in  the  prioritisation  and  regulation  of  FCMs.  Similarly,  new  scientific 
developments in risk assessment have been identified by EFSA in 2016, including the need to 
better  address  vulnerable  population  groups  (see  section  5.1.4)  and  with  more  focus  on  the 
final article. However, a new approach to regulating specific materials would first be required 
to  address  these  findings  since  the  current  approach  is  poorly  compatible,  e.g.  requiring 
multiple migration limits for the same article.  

Furthermore,  very  few  notifications  have  been  made  to  the  Commission  from  applicants  or 
businesses  with  new  scientific  or  technical  information,  which  might  affect  the  safety 
assessment  of  the  authorised  substance,  as  required  by  the  legislation.  In  contrast,  several 
examples  have  recently  come  to  light  where  new  information  has  been  made  available,  for 
example data generated under REACH, prompting the Commission to proactively request re-
assessments,  including  a  recent  request  to  prioritise  substances  with  no  SML136.  Failure  to 
automatically  generate  such  re-assessments  may  be  caused  by  a  lack  of  incentive  or 
knowledge on the part of the applicant or business operator in the absence of a legal deadline 
to  review  the  substance,  or  moreover,  simply  imply  that  the  substance  is  no  longer  used. 
Therefore, risk assessments fail to keep pace with science, which in turn are not incorporated 
into risk management. 

Innovation also appears to be hampered by the current Union list approach. Once authorised, 
a  substance  may  be  used  by  anyone  else,  promoting  the  status  quo,  i.e.  the  use  of  already 
listed substances, rather than innovation and new FCMs that may be beneficial to industry and 
consumers alike. As identified in section 5.2.5, only a very small fraction of all applications 
for substances are submitted by SMEs. The current system therefore appears biased towards 
larger businesses, in part possibly because they can afford the costs linked to the development 
of  the  substance  and  application  for  its  authorisation  but  also  losses  in  terms  of 
competitiveness. This is likely to discourage innovators, especially smaller operators, and is in 
contrast  with  the  US  FDA  Food  Contact  Notification  system,  where  authorisations  are  only 
granted to applicants.  

Some  businesses  also  mentioned  the  length  of  the  risk  assessment  procedure  as  a  hurdle  to 
more innovation in the field. The public consultation40 results showed that 45% of businesses 
consider  that  the  duration  of  the  assessment  and  authorisation  process  does  not  support 
innovation.  The  perception  of  businesses  is  that  the  requirements  for  safety  assessment  of 
substances  have  increased  and  it  incentivises  them  to  use  approved  substances  rather  than 
substituting  them  with  new  ones.  Whereas  EU  guidelines  for  the  assessment  of  substances 

135 http://data.europa.eu/eli/reg/2008/1272/oj 
136 https://doi.org/10.2903/j.efsa.2020.6124  

46 

 
                                                 
 
have been updated based on new knowledge and understanding, such perception may also be 
based on the length of time taken from the development of a substance to authorisation at EU 
level – in particular the latter part of the process which industry feels is too long (see section 
5.2.5). 

5.4.  Coherence 

Q8.  To  what  extent  is  the  FCM  Regulation  internally  coherent,  including  all  of  its 
implementing acts? 

5.4.1.  Internal coherence 
In general, there is a broad consensus among consulted stakeholders that the FCM Regulation 
itself  and  the  specific  EU  rules  adopted  under  that  regulation  are  generally  coherent  and 
function  as  intended  as  supported  by  stakeholders  during  the  consultation  activities.  This 
includes the GMP  Regulation  as well as the  plastics  Regulation.  These pieces of legislation 
deploy the use of the procedures set  out  in  the FCM Regulation  concerning assessment and 
authorisation of substances and processes.  

However,  inconsistencies  –  mainly  gaps  –  also  exist,  which  generate  uncertainties  and  may 
compromise the two aims of the FCM Regulation of ensuring safety and functioning of the 
internal  market.  In  line  with  the  views  of  stakeholders  concerning  the  existence  of  national 
measures40,76,137  it  can  be  concluded  that  the  main  incoherence  stems  from  Article  6  of  the 
FCM Regulation, which enables Member States to adopt or maintain their own national rules. 
As  described  earlier  in  section  5.1.5  on  effectiveness,  Member  States’  approaches  and 
national legislations often differ and in part contradict each other, which act against efforts for 
a common consensus on safety and functioning of the internal market for FCMs for which no 
EU-specific measures exist. 

These  issues  were  repeatedly  raised  by  stakeholders  during  many  of  the  consultation 
activities.  In  the  replies  to  the  public  consultation40,  70%  of  public  authorities,  60%  of 
business associations and 100% of NGOs who reported a gap in the legislation identified the 
presence of national measures/lack of EU-specific measures as a main reason for the gap. As 
well  as  creating  barriers  to  the  smooth  functioning  of  the  internal  market,  the  situation  also 
creates  distrust  by  consumer  organisations  and  raises  concerns  about  the  way  that  public 
health is protected. 

Another  inconsistency  identified  within  the  FCM  legislation  itself  concerns  the  lack  of 
analytical methods which have been assessed and validated sufficiently to control authorised 
substances and ensure compliance and enforcement of restrictions, such as SMLs. This in part 
is caused by the complexity and diversity of plastic FCMs, their chemical constituents, who 
then  come  into  contact  with  multiple  different  food  types.  Accreditation  of  analytical 
methodology  is  burdensome,  expensive  and  requires  regular  testing/use  of  those  methods. 
EFSA,  which  is  tasked  with  making  the  assessments  of  the  methods  according  to  the  FCM 
Regulation, does not have the full capacity to do so, even though analysts are appointed in its 
assessment work. DoCs are made on real materials, which may be inconsistent with the model 
materials evaluated by EFSA, as they may give rise to a different migration pattern. This also 

137 Ecorys report, Focus Group 4 “Effects of the lack of harmonisation” 

47 

 
                                                 
 
causes  a  challenge  for  enforcement  bodies  and  not  all  possible  migration  scenarios  are 
comprehensively accounted for. 

Contrary  to  the  requirements  of  the  FCM  Regulation,  it  is  not  within  the  remit  of  EFSA  to 
assist  in  developing  technical  guidance  on  sampling  and  testing.  The  EURL-FCM,  (the 
Commission’s JRC), which has the competence and the capacity, is now struggling to supply 
the  network  of  national  reference  laboratories  with  suitable  analytical  methods;  in  part, 
because  this  information  may  be  ‘hidden’  in  confidential  documentation  submitted  with  the 
application  to  EFSA,  or  because  the  relevant  data  dating  from  before  the  establishment  of 
EFSA are frequently missing. 

The complex rules regarding multi-material multi-layer articles in the plastics Regulation also 
weaken  internal  coherence  according  to  some  stakeholders76.  Difficulties  arise  when  such 
articles contain substances that are not on the Union list for plastics and substances (see figure 
7, annex 5) but which are present in other materials, but where it is not possible to verify from 
which material or layer the non-listed substance originates. DoCs may relate only to part of 
the article and where SMLs do not apply because of the presence of non-plastic material.  

In  the  absence  of  clear  rules  and  given  the  complexity  of  ensuring  compliance,  businesses 
(often  at  retail  stage)  often  request  compliance  with  their  own  national  law  for  materials 
without specific EU measures. This is similar to the situation prevailing before the entry into 
force  of  specific  EU  measures.  The  complexity  of  the  rules  may  thus  hinder  mutual 
recognition,  while  the  first  objective  of  the  FCM  Regulation  is  related  to  the  effective 
functioning of the internal market. 

Gaps also currently exist in the implementation of existing specific EU measures for AIM and 
recycled plastic FCMs, as described in section 5.3.  

Q9.  To  what  extent  are  the  FCM  Regulation  and  its  subsequent  implementation 
including  the  risk  assessment  and  risk  management  approaches  taken,  externally 
coherent with other relevant legislation and policies? 

5.4.2.  External coherence 
FCM  legislation  is  complementary  to  other  legislation  designed  to  protect  consumers  from 
hazards  arising  from  exposure  to  chemicals  through  food.  In  particular,  it  has  ensured 
coherence with the basic provisions of General Food Law11, which cover food and feed. The 
REFIT  Evaluation  of  the  General  Food  Law  (GFL)35  also  supports  the  coherence  of  the 
systematic  application  of  the  risk  analysis  principle  in  all  EU  secondary  food  legislation, 
including FCMs and the EU level risk assessments provided by EFSA. Furthermore, specific 
rules  in  FCM  legislation  take  into  account  situations  where  the  same  substance  may  be 
assessed  and  authorised  under  other  specific  food  laws,  such  as  components  of  AIM.  FCM 
legislation is therefore coherent with other EU food laws. 

Similarly,  the  FCM  Regulation  is  complementary  to  other  legislation  designed  to  protect 
citizens  from  chemicals  to  which  they  may  be  exposed  in  the  environment  or  via  other 
consumer  products.  Whereas  many  substances,  including  those  used  in  FCMs,  need  to  be 
registered under REACH, further risk assessment and risk management taken under REACH 
are not specific to FCMs; and with the exception of substances requiring authorisation under 
REACH because of environmental concerns, assessment and management of substances that 
may pose a risk to human health through exposure from FCMs are carried out only under the 

48 

 
FCM Regulation. Largely, therefore, the two pieces of legislation have complementary tasks 
to protect citizens. 
However,  nearly  half  (49%)  of  respondents  to  the  public  consultation40  report  that  they  are 
aware of contradictions, gaps, overlaps, inconsistencies or missing links between the EU FCM 
legislation and other EU legislation, relating particularly to chemical or product safety, while 
only  15%  indicate  that  they  are  not  aware  of  such  issues  (see  figure  4  below).  The  most 
frequently  reported  issue  concerns  coherence  and  consistency  between  the  FCM  Regulation 
and REACH. In particular, NGOs express the view that substances identified as CMR under 
the CLP Regulation or as being of ‘Very High Concern’ (SVHC) under REACH should not 
be authorised for use in  FCMs, regardless of migration potential, exposure and specific risk 
assessment.  

Specific risk approach (SRA) and generic risk approach (GRA) 

The  main  difference  identified  between  the  FCM  Regulation  and  other  legislation  is  the 
approach taken to risk assessing and risk managing certain substances. FCM legislation takes 
a  specific  risk  approach  (SRA),  where  the  specific  use  in  plastic  FCMs,  exposure  to 
consumers via that route and possible health risks to humans are taken into account before an 
authorisation is given. Other legislation applies a generic risk approach (GRA), which focuses 
more on the intrinsic hazard properties of a substance. The GRA-based approach is built into 
some  legislation  in  the  form  of  an  automatic  trigger  of  pre-determined  risk  management 
measures (e.g. packaging requirement, communication requirement, restrictions, bans, etc.). 

Figure 4: Stakeholders’ opinion regarding external coherence. Source: public 
consultation (Q23)40 

Are you are aware of any contradictions, gaps, overlaps, inconsistencies or 
missing links between the EU FCM legislation and other EU legislation, in 
particular on chemical safety or products?

Total

49%

15%

18%

18%

Public authority

38%

8%

30%

24%

Businesses

48%

18%

18%

16%

NGOs

100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

yes

no

don't know

no opinion

Examples of EU legislation using the GRA approach, at least in part for the most hazardous 
substances,  include  EU  legislation  on  cosmetics,  where  any  substance  classified  as  CMR 
categories 1A/B and 2, are banned from use (subject to strict derogations). This is based on 
the generic consideration that direct exposure of humans takes place through the application 
of  a  cosmetic  product  on  the  external  parts  of  the  human  body  (or  mouth).  Thus,  BPA  for 
example, is  prohibited for use in  cosmetics but not  in  FCMs. Similar approaches have been 
taken for CMR substances in toys.  

49 

 
 
 
The  REACH  Regulation  typically  deploys  the  GRA  in  the  authorisation  process,  since 
inclusion  in  its  Annex  XIV  (list  of  substances  subject  to  authorisation)  is  based  firstly  on 
hazard. Additional prioritisation is given to substances with high volumes and wide dispersive 
uses.  The  restriction  procedure  in  Article  68(2)  gives  a  simplified  restriction  procedure  for 
CMRs, cutting out the detailed risk assessment and socio-economic assessment that is part of 
the normal restriction process.  

Few substances subject to authorisation in Annex XIV, particularly because of human health 
concerns,  are  authorised  for  use  in  plastic  FCMs,  with  notable  exceptions  of  certain 
phthalates.  The  incoherence  in  practice  concerning  the  same  substances  subject  to 
authorisation under REACH and permitted in plastic FCMs are therefore currently very small. 
Furthermore,  substances  may  still  be  authorised  or  exempt  from  authorisation  for  a  specific 
use under REACH (e.g. phthalates in the packaging of medicinal products), which may lead 
to a similar outcome as for FCMs.  

Classification  of  CMR  does  not  necessarily  mean  that  there  is  a  risk  when  the  substance  is 
used  in  a  certain  application.  The  plastics  Regulation  authorises  some  reactive  monomers, 
which  have  been  classified  as  CMR  in  REACH.  In  the  1990s,  these  substances  were 
recognised  as  CMRs  in  the  safety  assessment  by  the  Scientific  Committee  on  Food  (SCF). 
Nonetheless,  they  were  authorised  because  they  are  highly  reactive,  and  they  are  no  longer 
present  after  polymerisation;  safety  assessments  verified  that  they  are  not  present  (not 
detectable) in  the final  FCM. Consequently, these monomers are listed in the Union list  for 
plastic  FCMs.  In  addition,  it  is  often  possible  to  establish  safe  levels  of  exposure  to  certain 
carcinogens, for example, and therefore even if trace amounts remain, exposure is such that 
no risk is identified.  
This is exemplified by a recent study138 that compiled a list of monomers listed in Annex I of 
the  plastics  Regulation,  their  classification  as  CMR  substances  according  to  the  CLP 
Regulation,  and  their  maximum  concentration/migration  limits  permitted  in  toys.  It  lists  20 
substances authorised for use in plastic FCMs, for which a non-detect (ND) requirement is set 
in the plastics Regulation for each substance that has been identified as CMR category 1A or 
B. An exception to this is formaldehyde (Carc1B), for which the main route of exposure does 
not  arise  from  FCMs  but  is  nevertheless  currently  under  discussion  within  the  FCM  Expert 
Working Group and BPA (Rep1B), which is discussed later in this section. 

Despite  this,  and  although  the  Fitness  Check  of  the  most  relevant  chemicals  legislation 
(excluding REACH) (see section 4.1) concluded that there are advantages and drawbacks to 
both  the  SRA  approach  and  the  GRA  approach,  the  different  approaches,  especially  for  the 
most  hazardous  substances  including  CMRs,  persistent  and  bioaccumulative  toxins  (PBTs) 
and very persistent and very bioaccumulative toxins (vPvBs), are seen by some stakeholders, 
particularly NGOs as a major inconsistency. The issue is compounded for non-plastic FCMs 
for  which  no  risk  assessment  or  specific  risk  management  measures  exists  for  known  or 
potential CMRs in these materials, at least at EU level.  

138  CMR  substances  in  consumer  products:  from  food  contact  materials  to  toys.  Ariane  Lenzner,  Bärbel  Vieth  &  Andreas 

Luch. Archives of Toxicology volume 92, pages1663–1671(2018). 

50 

 
                                                 
 
As  well  as  CMRs,  incoherence  also  exists  as  regards  the  approach  to  regulating  substances 
that  have  endocrine  disrupting  properties  (EDs).  Although  substances  identified  under 
separate  legislation  as  having  endocrine  disrupting  properties  are  specifically  risk  assessed 
when  used  to  manufacture  plastic  FCMs,  which  may  in  turn  take  into  consideration  these 
properties,  the  legislation  does  not  specifically  mention  or  prioritise  them  and  consequently 
does not define them. On the other hand, legislation on plant protection products and biocidal 
products set scientific criteria with automatic consequences, i.e. a ban unless a justification for 
exemption  can be made. Other pieces of legislation also  contain provisions  that specifically 
addresses endocrine disruptors, including REACH and medical devices legislation.  

The  absence  of  horizontal  criteria  for  the  identification  and  classification  of  endocrine 
disruptors  across  relevant  EU  legislation  has  also  been  criticised  by  a  number  of  different 
stakeholder groups including both NGOs and industry, as well as national authorities and was 
identified  as  an  area  for  action  in  the  EU's  7th Environment  Action  Programme. Endocrine 
disruptors  have  recently  been  subject  to  a  cross-cutting  Fitness  Check139,  which  identified 
some incoherence in the horizontal approach across legislation and in data requirements and 
possible  gaps  in  addressing  vulnerable  populations.  Despite  differences  in  risk  management 
approaches,  however,  it  found  no  cases  of  inconsistent  risk  management  for  specific 
substances  based  on  the  lack  of  a  horizontal  approach  to  the  identification  of  substances  or 
any  other  consideration  specific  to  endocrine  disrupting  properties,  limited  as  it  was  by  the 
small number of substances examined. 

Issues specific to REACH 
Most  chemicals  used  to  manufacture  products  (whether  or  not  FCMs)  are  subject  to  the 
REACH registration process, as they are often produced in high volumes. In accordance with 
the  REACH  Regulation,  FCM  substances  that  have  been  placed  in  Annex  XIV  of  REACH 
(list of substances requiring authorisation) due to their human health hazards are exempt from 
authorisation  requirements  for  food  contact  use  because  the  FCM  legislation  specifically 
controls  health  risks.  They  remain  subject  to  REACH  authorisation  with  respect  to 
occupational or environmental risks.  

By  way  of  example,  the  plastics  Regulation  authorises  perfluorooctanoic  acid  (PFOA) 
following  an  opinion  from  EFSA  concerning  its  specific  use  in  FCMs  (non-stick  coating), 
which leads to a negligible dietary exposure and is considered safe for human health. On the 
other  hand,  ECHA  has  identified  it  as  toxic  and  highly  persistent  in  the  environment. 
Consequently, PFOA was restricted in Annex XVII of REACH entry 68140 and subsequently 
transferred to Regulation (EU) 2019/1021 on Persistent Organic Pollutants141. This restriction 
includes  its  presence  in  FCMs,  but  as  emphasised  in  the  focus  group  on  coherence142, 
withdrawal  from  the Union list  is not  possible  under the FCM Regulation,  since there is  no 
mechanism in place to do this, only following an opinion by EFSA. The continued listing of 

139 {COM(2020) 667 final}  - {SWD(2020) 225 final}  - {SWD(2020) 247 final}  - {SWD(2020) 248 final}  - {SWD(2020) 

249 final} - {SWD(2020) 250 final} https://ec.europa.eu/info/policies/endocrine-disruptors_en  

140 http://data.europa.eu/eli/reg/2017/1000/oj  
141 http://data.europa.eu/eli/reg/2019/1021/oj 
142 Ecorys report, focus group 3 “Risk assessment and REACH-FCM interaction” 

51 

 
                                                 
 
PFOA in the plastics Regulation is likely to cause confusion for FCM producers and suggests 
a need to ensure better coherence. 

Annex  XVII  of  REACH  also  includes  restrictions  for  substances  that  pose  an  unacceptable 
risk to human health and the environment that are not adequately controlled and that must be 
restricted  at  EU  level.  There  is  no  general  exemption  for  FCM  substances  unless  a  specific 
exemption is stated in the corresponding entry in Annex XVII (such as that for lead).  

Occasionally, restrictions on substances in Annex XVII of REACH include their presence in 
FCMs,  such  as  PAHs  in  plastic  drinking  utensils  or  phthalates  in  childcare  feeding  articles. 
However, national measures may exist for PAHs in FCMs in accordance with Article 6 of the 
FCM  Regulation  and  indeed  do  exist  for  phthalates  in  plastic  FCMs  under  the  plastics 
Regulation. This appears to present an overlap and has the potential to cause confusion among 
stakeholders. 

Overall,  the  main  difference  between  FCM  legislation  and  other  EU  legislation  such  as 
REACH is the approach taken to the management of the most harmful chemicals, where the 
latter  also  deploys  a  more  hazard-based  approach  as  well  as  specific  risk  assessment.  Some 
overlaps have also been identified where both sets of legislation regulate FCMs, which may 
lead to confusion amongst businesses. Specific EU rules applicable to FCMs are inconsistent 
in a limited number of cases, where authorisation of a substance  under the FCM Regulation 
continues  despite  action  taken  under  REACH  on  environmental  grounds.  An  increase  in 
recycling and re-use of materials under sectorial legislation must also be taken into account in 
the FCM legislation to ensure safety. 

Cooperation of EU Agencies 
The  ECHA-EFSA  memorandum  of  understanding143  sets  the  framework  for  cooperation 
between  the  two  EU  agencies,  including  scientific  collaboration  and  information  exchange, 
hazard  and  risk  assessment  of  chemical  substances  and  exchange  of  scientific  data  and 
experience  in  developing  scientific  IT  and  support  tools.  This  is  highlighted  in  the  Fitness 
Check of the GFL. 

Although both agencies consult each other, where possible and appropriate, when delivering 
scientific  advice  and  risk  assessments  that  concern  the  safety  of  chemicals  in  food,  there  is 
still  scope  for  greater  coherence  in  the  approach  to  risk  assessment.  The  findings  of  the 
Fitness  Check  of  the  most  relevant  chemicals  legislation  (excluding  REACH)37  highlighted 
the complexity of assessment procedures, which represents a specific challenge for authorities 
and stakeholders and can lead to inconsistencies, slow procedures, inefficient use of resources 
and  unnecessary  burdens.  Interviewed  stakeholders  and  those  participating  in  the  public 
consultation40 demonstrate a consensus on the potential for stronger synergy between REACH 
and  FCM  Regulation,  as  they  collect  information  on  similar  materials.  This  should  be 
facilitated  following  the  adoption  of  the  Memorandum  of  Understanding  between  both 
agencies. 

Possible inconsistencies with other EU legislation  

143 https://www.efsa.europa.eu/sites/default/files/assets/mouecha.pdf  

52 

 
                                                 
 
An example of incoherence also exists between the FCM Regulation and  the EU Regulation 
on  medical  devices.  This  is  exemplified  by  feeding  tubes  used  for  administering  foods  for 
special  medical  purposes,  which  are  both  medical  devices  and  FCMs  according  to  the 
respective regulations. However, the Regulation on medical devices does not necessarily have 
the  same  approach  to  migration  of  chemical  substances  as  the  FCM  Regulation,  since  there 
could be other issues to consider for the patients’ safety. For example, some tubes for feeding 
premature  babies  require  a  composition  that  makes  them  sufficiently  soft,  so  they  don’t 
perforate  the  stomach  of  the  children.  Rules  on  the  content  of  phthalates  in  these  tubes  to 
plasticize them differ from the rules in the plastics Regulation. Although the benefits of using 
devices for medical purposes in most scenarios are likely to outweigh the possible risks from 
migration of substances from the medical device, legal clarity could be improved. 

Overlaps  also  now  exist  in  the  case  of  biocidal  substances  used  in  plastic  FCMs.  A  small 
number of substances used as biocides are still subject to national rules144 in accordance with 
the plastics Regulation,  whereas since 2012, use of biocidal  substances in biocidal  products 
incorporated  into  FCMs  has  required  approval  and  authorisation  respectively  under 
Regulation  (EU)  No  528/2021.  This  has  also  led  to  confusion  amongst  stakeholders  as 
demonstrated  by  correspondence  to  the  Commission,  requesting  clarification  on  whether  an 
application requires an assessment under the FCM Regulation, Regulation (EU) No 528/2012 
or both. 

Some  questions  have  been  raised  on  the  coherence  between  the  FCM  Regulation  and  the 
recently  updated  waste  management  legislation  (Directive  (EU)  2018/851  on  waste145).  This 
Directive sets requirements for FCM producers to increase recycling rates. On the other hand, 
Regulation (EC) No 282/2008 places a major emphasis on food safety when new FCMs are 
made from post-consumer recycled FCMs. The objectives of the two pieces of legislation do 
not contradict each other but may create challenges to one another, since the need to ensure 
safety can hamper the recycling of certain materials that contain hazardous substances. 

Post-consumer  recycled  materials  may  be  contaminated  with  various  chemicals.  Although 
many processes for PET recycling allow contaminants of concern to be efficiently removed, 
not all polymers can be purified and recycled into new materials equivalent to virgin polymers 
compliant  with  FCM  rules.  EFSA  guidance  is  provided  for  applications  on  processes  to 
decontaminate  plastic  FCMs  during  the  recycling  process,  depending  on  the  polymers,  the 
processes,  and  the  intended  uses.  However,  current  recycling  processes  do  not  enable  a 
purification of polyolefins and removal of contaminants of concern, although polyolefins have 
an important market position and their recycling is necessary to achieve recycling targets. 

Global regulation of FCMs 
There  are  no  common  global  standards  for  FCMs  as  there  are  for  other  sectors,  such  as 
pesticides and contaminants under Codex Alimentarius. The main system that differs from the 
EU is that of the US FDA. Whilst there are parallels between the EU and the US FDA system, 
the main difference is that authorisation is exclusive to the manufacturer or supplier. As noted 
in section 5.2.5, the authorisation process is also generally quicker than in the EU.  

144 https://ec.europa.eu/food/system/files/2016-10/cs_fcm_legis_additives-prov-list.pdf  
145 http://data.europa.eu/eli/dir/2018/851/oj 

53 

 
                                                 
 
The approach also differs insofar as the US permits certain exemptions including substances 
at  low  exposure  or  because  they  are  food  additives  or  are  “Generally  Recognised  As  Safe 
(GRAS)”. In contrast, the EU approach requires at least a basic toxicological evaluation of the 
listed substances, regardless of exposure. 

On the other hand, many FCM regulators across the world have, by and large, been evolving 
their systems broadly based on the approach taken by the EU. This includes the switch from a 
negative  list  system  in  Japan  to  one  comprising  positive 
lists146 and most notably, a replication of the EU  general 
requirements  and  regulatory  framework  system  (GB 
4806.1-2016),  including  requirements  for  a  DoC  and 
labelling  with  symbols  representing  more  common 
utensils  in  China  (see  right).  The  system  in  China  also 
deploys  the  use  of  an  authorised  list  of  additives  (GB 
9685-2016), using similar restrictions such  as SMLs (see 
figure 8 in annex 5). Work has  now progressed  in  China 
and  legislation  incorporates  additional  requirements  on 
plastic as well as rubber, inks, coatings and adhesives. 

Although the EU and Chinese systems have a similar structure and approach in a number of 
aspects,  feedback  from  interviews  indicates  that  there  is  more  room  for  coherence.  Future 
trends  in  packaging  and  other  FCMs  may  also  drive  regulators  in  the  same  direction,  in 
particular in areas such as vulnerable populations and regulation of more novel materials as 
well  as  paying  greater  attention  to  “chemicals  of  concern”  and  recycling  of  FCMs147.  This 
could potentially pave the way for enhanced synergies between global regulators. 

5.5.  EU added value 

Q10.  What  is  the  EU  added-value  of  the  FCM  Regulation  in  relation  to  its  main 
objectives? 

The EU legislation has brought value in ensuring the safety of FCMs and the functioning of 
the  single  market  through  common  principles,  language  and  regulatory  approach,  and 
harmonised specific rules for some materials. This includes setting the ground for harmonised 
rules  for  listed  materials,  a  defined  assessment  and  authorisation  procedure  for  ensuring 
substances used in making those materials are safe, rules regarding labelling and traceability 
for  consumers  and  businesses  along  the  supply  chain,  and  controlling  and  enforcing  the 
legislation. Further benefits include the introduction of an EU risk assessment process centred 
around EFSA and the formation of the EURL-FCM and network of NRLs, which facilitate a 
coherent approach to method development and guidance on ways to ensure compliance. 

The FCM Regulation did not completely transfer responsibility to the EU level. The powers to 
control  and  enforce  remain  with  the  Member  States.  The  key  provision  providing  Member 

146 https://www.ul.com/news/japan-adopts-positive-list-system-manage-food-contact-materials-fcm  
147  Future  trends  in  global  food  packaging  regulation.  lJ.S.Baughan.  Global  Legislation  for  Food  Contact  Materials 
Woodhead Publishing Series in Food Science, Technology and Nutrition, 2015, Pages 65-74. https://doi.org/10.1016/B978-1-
78242-014-9.00003-6  

54 

 
                                                 
 
States with the autonomy to act independently is Article 6. It allows them to maintain or adopt 
national provisions in the absence of specific measures.  

The clearest added-value brought about by EU intervention is the progressive harmonisation 
and provision of more specific rules over the last four decades. Significant milestones include 
the  introduction  of  EU  lists  of  substances  authorised  for  use  in  plastic  FCMs  and  the 
replacement of the Member State authorisation provision (article 4 of Directive 89/109/EEC) 
with the Union authorisation process.  

In  particular,  the  EU-specific  rules  in  the  plastics  Regulation,  including  a  Union  list  of 
authorised  starting  substances,  additional  compositional  requirements,  restrictions  including 
SMLs  and  rules  on  verification  of  compliance  and  documentation  in  the  supply  chain  have 
had  positive  effects  on  both  the  effectiveness  and  efficiency  of  regulating  FCMs.  These 
positive effects were further solidified in 2011 with the inclusion of multi-material multi-layer 
plastics.  According  to  stakeholders,  these  specific  rules  have  brought  an  increased  level  of 
consumer  protection,  enhanced  cooperation  and  controls  amongst  Member  States  and 
provided greater legal certainty to businesses. These effects are enhanced at EU level because 
they help to define what is required in order to ensure compliance with Article 3 of the FCM 
Regulation and avoid differences that occur as a result of national legislation. 

So  far,  the  EU  added-value  has  been  limited.  Over  30  years  after  the  entry  into  force  of 
Directive  89/109/EEC,  which  set  provisions  for  introducing  specific  rules  for  specified 
materials, specific measures are in place for only four materials (plastics and recycled plastics, 
ceramics,  AIM,  and  RCF).  This  ‘incomplete  implementation’  has  a  negative  impact  on  the 
overall performance and the added-value of the EU legislation on FCMs.  

For  materials  not  subject  to  specific  EU  rules,  different  national  approaches  remain  in  the 
absence  of  EU-specific  legislation,  hampering  trade  on  the  internal  market.  Reliance  on 
national measures also raises doubts about the safety of some non-plastic materials, creating 
uncertainty and barriers to trade for businesses. Companies are required to invest in additional 
tests and to provide documentation in order to meet national requirements and varying client 
requirements.  It  also  makes  controls  and  enforcement  more  difficult,  due  to  the  complexity 
and cross-cutting nature of the topic and lack of resources and expertise in Member States but 
also among businesses. 

The EU’s mutual recognition principle appears to be correctly applied to a limited extent and 
the  difficulties  encountered  are  higher  for  SMEs.  As  illustrated  in  section  2  of  the  JRC 
‘baseline’ study7, supply chains are set up to supply the EU market, rather than being country 
specific and this may also explain the difficulties encountered with multiple rules in different 
EU Member States. 

There is a consensus among Member States, citizens and other stakeholder categories that EU 
intervention is necessary and of great added-value. Member States, citizens and stakeholders 
confirmed  in  all  of  the  consultation  activities  that  further  action  at  EU  level  is  needed.  For 
Member States, and in particular in the smaller countries, harmonisation helps to implement 
the  legislation  at  lower  costs.  For  NGOs,  harmonisation  is  considered  a  way  to  improve 
consumer  protection  and  ensure  that  it  is  equal  for  all  EU  citizens.  For  companies, 
harmonisation guarantees the functioning of the internal market. It is particularly the case for 
SMEs  as  illustrated  in  figure  9,  annex  5.  Finally,  for  consumers,  results  from  the 
consultation37  show  that  the  level  of  trust  regarding  safety  issues  is  the  highest  for  EU 
authorities. 

55 

 
6.  CONCLUSIONS 
Increasing  experience  with  the  functioning  of  the  FCM  Regulation  over  many  years  has 
stimulated  discussion  and  reflections  between  the  Commission,  EU  Member  States  and 
stakeholders;  not  only  on  the  anticipated  impacts  and  outcomes  but  moreover  on  several 
fundamental issues with the existing approach to regulating FCMs at EU level.  The purpose 
of this exercise was therefore to formally evaluate and document, with supporting evidence, 
the  functioning  of  the  FCM  Regulation  in  relation  to  its  original  objectives,  whilst 
acknowledging that no previous assessments or monitoring of the FCM Regulation have taken 
place  as  well  as  the  difficulties  in  collecting  information  from  stakeholders  and  generating 
quantitative data. 

The evaluation has found that EU FCM Regulation is partly effective in fulfilling its two main 
objectives.  The  scope  of  the  Regulation  is  generally  clear,  although  there  are  differences  in 
the interpretation of the status of some items that may come into contact with food, leading to 
legal  uncertainty.  There  are  questions  about  the  full  effectiveness  of  labelling  and 
communication  to  consumers,  including  the  use  of  symbols  or  pictograms.  Definitions  are 
generally  clear,  but  difficulties  may  arise  in  delineating  between  similar  material  types 
including those made from synthetic polymers. No specific issues were identified concerning 
traceability  within  the  FCM  supply  chain,  although  Member  States’  competent  authorities 
face challenges in the absence of compliance documentation and lack of business registration. 

initiatives, 

that  has  promoted  several  specific 

Article  3  of  the  FCM  Regulation  concerning  the  safety  of  FCMs  has  set  a  clear  legal 
including  EU-specific 
requirement 
(‘harmonised’)  measures,  national  measures  and  industry  standards.  A  similar  approach  has 
been successful in stimulating industry guidance on GMP. The main ‘harmonised’ approach 
has largely ensured the safety of starting substances used to manufacture plastic FCMs, based 
on a transparent EU risk assessment and provides legal certainty for industry. Businesses are 
generally  clear  on  their  roles  and  responsibilities  and  do  not  face  different  national 
requirements, allowing  good access  to  the EU market. Member States  rely  on  specific rules 
and have also adopted their own similar approaches for regulating other materials at national 
level. The EU rules are technically complex however and have required supplementation with 
guidance,  which  stakeholders  have  welcomed  although  may  still  be  beyond  the  routine 
understanding of SMEs, taking into account their normal resources. 

The development of a Union list of authorised substances has nevertheless been restricted to 
plastic  FCMs  as  well  as  RCF;  on  the  whole,  no  such  assessments,  authorisations  and 
associated restrictions have been introduced for other materials. The effectiveness for plastic 
FCMs  is  compromised  by  derogations  for  some  substances  such  as  colorants  and  so-called 
non-intentionally added  substances (NIAS). Risk assessment and management of authorised 
substances is not always assured in part because the most up-to-date science is not routinely 
incorporated  into  the  regulatory  process  and  questions  have  also  arisen  over  whether 
vulnerable populations and combinations of substances are sufficiently addressed. Exchange 
of safety and compliance information in the supply chain is also relatively poor and overall, 
the evaluation points to uncertainty and insufficient rules on how to ensure the safety of the 
final FCM sold to consumers.  

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  many  other 
materials, which may differ amongst stakeholders. Further, it does not state how safety should 

56 

 
be  achieved  or  how  it  can  be  demonstrated.  Many  national  measures  have  therefore  been 
introduced by Member States but are often incoherent across the EU for the same materials or 
the  same  substances.  This  creates  confusion  over  required  levels  of  safety  and  legal 
uncertainty for businesses, particularly SMEs, who may be faced, for example, with multiple 
testing  regimes,  increasing  costs  or  leaving  large  parts  of  the  EU  market  inaccessible.  The 
mutual  recognition  principle  does  not  appear  to  have  so  far  improved  the  situation.  The 
legislation has therefore generally been ineffective for most materials other than plastics. 

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  or  fully 
enforce the requirements of the legislation. Inspection and official controls are hampered by 
the lack of specific EU rules on which to base controls, lack of resources and prioritisation of 
FCMs, lack of validated methodology and inability to identify FCM businesses. On the other 
hand, specific EU rules on plastic FCMs are complex requiring high level expertise, which is 
often  lacking  in  Member  States.  Work  on  methods  of  analysis  is  supported  by  the  EURL-
FCM  and  NRL  network  but  this  is  complex  and  resource  intensive  for  the  number  of 
substances  that  are  authorised  and  need  to  be  checked.  Validated  test  methods  are  absent 
except  for  a  small  sub-section  of  substances,  which  compromises  the  ability  to  verify 
restrictions. 

The presence and quality of declarations of compliance (DoC) and supporting documentation 
(SD)  were  found  to  be  insufficient  in  the  supply  chain,  which  also  makes  Member  States’ 
controls additionally challenging. Gaps have been identified in the flow of information along 
the  supply  chain  and  there  is  a  clear  need  to  standardise,  simplify  and  clarify  rules  on 
compliance documentation, improve the quality and exchange of information along the supply 
chain and reinforce the system of enforcement. 

Overall,  the  efficiency  of  the  FCM  legislation  appears  to  be  sub-optimal  although  health 
benefits  are still expected to  exceed the costs.  A relatively 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  intervention  was  made  until  the 
present.  However,  the  extent  of  the  health  benefits  will  vary  depending  on  the  risk  that  is 
being controlled i.e. exposure to a given substance. The efficiency of enforcement of the FCM 
legislation and subsequent benefits to consumers appears to be below its potential.  

Trade  data  does  not  provide  clear  evidence  of  enhanced  intra-EU  trade  due  to  FCM 
legislation. There is some evidence that harmonisation has a positive effect on intra-EU trade 
at  industry  level,  including  savings  on  the  preparation  of  dossiers  for  risk  assessment. 
Similarly, estimates suggest that there are some cost savings for Member States from EFSA 
risk assessments. However, overall, cost savings from the EU legislation are limited and relate 
to the existence of specific measures, in particular for plastic FCMs. 

Overall, costs to industry are estimated to be around 3% (EUR 3 billion) of the total turnover; 
the majority of those costs are spent on compliance (~2%), with a smaller proportion (~1%) 
spent on administrative costs. Costs vary depending on the sector involved and the role of the 
business  in  the  supply  chain.  Compliance  costs  are  borne  principally  by  manufacturers  and 
convertors, including dossier preparation, GMP and analytical testing.  

Annual  costs  spent  by  EU  Member  States,  through  either  implementation  of  EU  rules  or 
national measures are estimated at less than EUR 1 million per Member State. Costs are made 
up  of  staff  time,  annual  control  costs  as  well  as  some  risk  assessment  work  that  is  done  at 

57 

 
national level. Annual costs spent by EU institutions are approximately EUR 3.4 million. This 
includes the risk management done by the Commission on EU legislation as well as training 
and  audits;  method  development  and  support  to  Member  States  on  controls  and  risk 
assessment work undertaken by EFSA. 

For certain industry sectors, for whom there are no EU-specific measures, costs may be even 
higher (up to 10%) due to multiple national requirements. Unilateral action by Member States 
under  safeguard  measures  provided  for  by  the  legislation  has  significantly  increased  costs. 
SMEs  do  not  have  the  resources  to  submit  dossiers  to  EFSA  and  many  consider  that  costs 
linked to the FCM legislation are not proportionate to the size of companies.  

On  the  other  hand,  the  EU  system  of  authorising  starting  substances  in  plastic  FCMs  also 
suffers from inefficiencies. This includes the time taken for authorisation to be given, taking 
into account the costs and resources to industry of the data generation and application process. 
EU  resources  needed  for  the  plastics  Regulation,  including  EFSA  as  risk  assessor  and  the 
Commission  as  risk  manager  are  unavailable  for  other  material  types,  using  the  same 
approach. Efficiency gains could be made with  a less specific approach as many substances 
are used in  more than one material  type. Moreover, the  current  approach is  potentially sub-
optimal,  as  it  does  not  address  the  most  hazardous  substances  migrating  from  all  materials. 
Doing so could lead to greater efficiency through enhanced health gains whilst making use of 
existing relevant information such as that generated under the REACH Regulation.  

Rules to protect consumers from potential risks arising from the migration of substances from 
FCMs  remain  relevant  with  citizens,  who  show  an  increased  interest  in  food  safety  issues 
including  those  relating  to  FCMs.  Trust  in  FCM  safety  standards  appears  reasonable  to 
consumers  but  views  from  NGOs  indicate  that  there  is  scope  for  further  improvement. 
Evidence  suggests  that  in  some  cases  unintended  use  or  reuse  of  FCMs  is  relevant  for 
consumers, whereas appropriate labelling may be unclear or absent.  

Businesses  continue  to  need  a  consistent  and  predictable  regulatory  platform  on  which  to 
produce, sell and trade their products across the EU with minimal burden whilst meeting their 
customers’  needs.  This  is  somewhat  hampered  in  the  absence  of  EU-specific  rules  beyond 
mainly plastic FCMs,  which many stakeholders  have  anticipated.  However, even  for plastic 
FCMs, it can be concluded that actors further along the supply chain require more clarity as 
regards the safety of final FCM articles. Familiarity and understanding of the FCM legislation 
decrease with the size of the business, indicating a need for greater support for SMEs. 

The  evaluation  points  to  a  need  for  clearer,  simpler  rules  that  are  more  commensurate  with 
Member  States’  resources,  an  emphasis  on  improving  access  to  compliance  documentation 
and  increased  training  and  transfer  of  knowledge.  Further  coordinated  controls  at  EU  level 
would also seem welcome. 

New and evolving science are partially addressed, including support from the EURL-FCM in 
the  implementation  of  the  legislation  and  the  development  of  analytical  methodology. 
Similarly,  EFSA  has  also  worked  on  identifying  emerging  risks,  including  substances 
migrating  from  FCMs,  and  set  up  a  network  of  experts  to  enhance  collaboration  between 
scientists involved in the risk assessment of FCMs to support and harmonise risk assessment 
practices.  

Yet questions remain over the relevance of and need for all substances still authorised from 
risk assessment and management carried out decades ago; whether new and improved FCMs 
may be more forthcoming in an environment that better supports innovation. Furthermore, if 

58 

 
older  substances  are  still  used,  it  is  likely  that  in  many  cases  information  generated  under 
other EU chemicals legislation could be used in the prioritisation and regulation of substances 
in FCMs. 

The EU FCM regime is also currently geared towards risk assessment and risk management 
of well-established chemistry, with a focus on defined starting substances to produce synthetic 
polymers 
the 
to  manufacture  plastics.  This  approach  has  proved  problematic 
implementation  of  legislation  on  AIM,  where  considerations  beyond  simply  substances  are 
needed.  And  while  bio-based  polymers  are  specifically  addressed  under  the  plastics 
Regulation, there are still clear gaps for materials for which no EU-specific measures have or 
even can be introduced, including materials used from more natural sources or that are more 
biodegradable – and in turn, potentially less inert.  

in 

Legislation  concerning  safe  recycling  of  plastic  FCMs  does  not  yet  fully  address  evolving 
technologies and needs to recycle not only other types of plastic and other types of materials, 
but also different approaches to recycling, including chemical recycling. Such technology is 
key to provide address future needs and challenges that cannot be addressed altogether with 
more traditional, mechanical recycling.  

Such  future  needs  are  linked  to  growing  consumer  interests  in  environmental  concerns  and 
EU  policy  itself  that  pushes  not  only  recycling  but  also  the  use  of  materials  that  are 
considered  more  environmentally  friendly,  such  as  those  that  are  bio-based  or  possess 
enhanced biodegradable properties compared with more traditionally produced plastics.  

The FCM Regulation itself and the specific EU rules adopted under it are generally internally 
coherent  and  function  as  intended.  The  main  ‘incoherence’  exists  between  the  objectives  of 
the  Regulation  and  Article  6,  which  has  allowed  Member  States  to  introduce  or  maintain 
national  measures  that  are  often  divergent  and  create  uneven  standards  for  protecting 
consumers and creating difficulties for trade on the internal market. 

Inconsistencies  also  exist  between  EU-specific  measures  and  the  feasibility  of  ensuring 
compliance  and  enforcing  the  rules.  The  capacity  for  EFSA  to  evaluate  a  test  methodology 
that is applicable in practice for all combinations of FCMS and food is limited. Furthermore, 
the  EURL-FCM  does  not  have  the  capacity  to  fully  develop  and  supply  a  methodology  to 
NRLs  commensurate  with  the  large  number  of  substances  for  which  SMLs  are  set. 
Accreditation  of  analytical  methodology,  which  is  burdensome,  expensive  and  requires 
regular use of those methods is an even greater challenge. 

For plastic FCMs, rules on multi-material multi-layer articles present problems, where some 
specific rules apply to plastic whereas national rules or no specific rules apply to other parts 
of  the  article.  Complications  arise  from  determining  where  NIAS  has  originated  from,  and 
which business operator has responsibility for ensuring compliance.  

Concerning links with non-FCM legislation, the FCM Regulation is generally coherent with 
the General Food Law, including definitions and the use of risk analysis principles. It is also 
complementary to other EU legislation such as REACH, which aims to protect citizens from 
exposure to potentially harmful chemicals, but which is not specific enough to ensure that the 
presence and migration from FCMs is sufficiently risk assessed and risk managed. Similarly, 
the  FCM  Regulation  complements  EU  legislation  on  other  consumer  products  such  as  toys 
and  cosmetics  as  well  as  medical  devices,  protecting  citizens  from  many  of  the  same 
chemicals  and  contributing  to  the  overall  limitation  of  exposure  to  certain  chemicals  where 
necessary. 

59 

 
Differences  do  exist  in  the  approach  taken  under  the  FCM  Regulation  compared  with 
approaches  taken  under  REACH  or  other  sector  specific  legislation  such  as  cosmetics  and 
toys. Whilst under the FCM Regulation, substances are assessed specifically for their use and 
migration  from  FCMs  taking  into  account  the  estimated  exposure,  (specific  risk  approach 
(SRA)),  many  other  pieces  of  EU  legislation  prioritise  substances  based  on  their  hazard 
properties.  REACH  includes  a  more  generic  risk  approach  (GRA)  with  certain  hazardous 
properties  that  are  automatically  prioritised  for  risk  management.  Although  incoherence  in 
practice is limited, the main consequence of this is a lack of prioritisation of safety matters in 
the FCM approach.  

Regulation  of  substances  under  the  FCM  Regulation  and  the  REACH  Regulation  may  be 
confusing for stakeholders, as illustrated by restrictions on substances introduced in the latter 
because  of  environmental  concerns,  that  cannot  be  taken  into  account  in  the  former  and 
continue  to  be  authorised.  Provisions  introduced  in  the  REACH  legislation  intended  to 
regulate substances due to environmental concerns cannot currently be reflected in the FCM 
legislation. Given the risk assessment and management of many substances falling under both 
FCM  legislation  and  the  REACH  Regulation,  there  is  greater  potential  for  stronger  synergy 
between these regulations and work between the two EU Agencies. 

Although no evidence exists per se that the current measures on FCMs are incoherent with the 
waste  management  legislation,  the  evaluation  has  identified  that  recent  EU  policies  and 
requirements  for  the  industry  to  increase  recycling  and  reduce  waste  will  create  increased 
challenges to ensure the safety of FCMs through recycling and use of new materials. This will 
need to be monitored and it is likely that a future FCM policy will have to be designed with 
this in mind to ensure safety.  

Apart from the system  in the US,  regulation  of  FCMs  in  the EU is  relatively  coherent  with 
third  countries,  which  in  general  have  followed  a  similar  approach  to  that  of  the  EU. 
However,  differences  also  exist  and  synergy  gains  could  be  made  concerning  key  issues  in 
future  regulation  of  FCMs,  such  as  chemicals  of  concern  and  regulation  of  more  novel 
materials. 

There is considerable EU added-value from regulation of FCMs at EU level compared with 
the situation at  national level.  In particular, the  EU-specific rules  in  the plastics Regulation, 
list  of  authorised  starting  substances,  additional  compositional 
including  a  Union 
requirements,  restrictions  including  SMLs  and  rules  on  verification  of  compliance  and 
documentation  in  the  supply  chain  have  had  positive  effects  on  both  the  effectiveness  and 
efficiency of regulating FCMs. They have provided equal protection of health for consumers 
across the EU as well as a level playing field for businesses. 

Conversely,  in  the  absence  of  EU-specific  rules  building  on  the  basic  requirements  of  the 
FCM Regulation and progressing harmonisation, non-plastic sectors appear to have struggled, 
which are discussed in  both  sections on effectiveness  and efficiency.  In the absence of  EU-
specific  measures,  national  measures  raise  doubts  about  the  safety  of  some  non-plastic 
materials,  create uncertainty  and barriers to  trade for businesses. Companies are required to 
invest in additional tests and to provide documentation in order to meet national requirements. 
The benefits of the EU’s mutual recognition principle appear to be limited and the difficulties 
are higher for SMEs.  

60 

 
Annex 1: Procedural information 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

DG SANTE, PLAN/2016/436 

2.  ORGANISATION AND TIMING 

During a 4-week period  28 November  – 26 December 2017, all interested  stakeholders 
were able to provide feedback on the FCM Evaluation Roadmap148. This was the first step 
of the consultation in order to receive feedback on the general consultation approach to 
the evaluation.  

A tender for a supporting study was published in 2018 and a contractor  was appointed. 
An overview of the organisation of their work is summarised in figure 5: 

Figure 5: Overview of the organisation of the supporting study 

The  consultation  period  was  launched  in  September  2018  with  a  stakeholder  workshop 
and the open public consultation37 for the evaluation followed on 11 February 2019. The 
consultation activities were carried out September 2018 – September 2019. 

148 https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-5809429_en  

61 

Evaluation structuring Data collection Data analysisConclusions and reportingEvaluation stageKey methodsKey deliverablesq Desk researchq Public Consultation q SME surveyq Case Studiesq Interviewsq Focus groupsq Consultation strategyq Intervention logicq Scoping interviewsq Evaluation matrixq 1st Workshopq Stakeholder consultation results analysisq Case studiesq Descriptive statisticsq Analysis of costs and benefitsInception report, q Reportingq 2nd WorkshopInterim reportDraft Final report and Final report 
 
 
 
  
                                                 
 
Within the Commission, an inter-service steering group (ISSG) was set up, including DG 
SANTE, DG ENV, DG GROW, SG, DG RTD, DG AGRI, DG TRADE, JRC and EFSA. 
Four  meetings  were  held  between  February  2018  and  September  2019  to  appraise  and 
discuss the progress of the supporting study as well as the final output. A final meeting to 
discuss this staff working document was held on 8 June 2021, which was also subject to 
an inter-service consultation in March 2022. 

3.  EXCEPTIONS TO THE BETTER REGULATION GUIDELINES 

None 

4.  CONSULTATION OF THE RSB  

Yes 

5.  EVIDENCE, SOURCES AND QUALITY 

The evaluation relies largely on the following sources:  

  Supporting study including all consultation activities described in annex 2; 

  JRC baseline study; 

  BTSF  Workshop  report  on  strengthening  Member  States'  response  to  Union 

audits on FCMs; 

  Study  on  the  use  of  compliance  documentation  in  official  controls  and  in  the 

supply chain; 

  Correspondence and  evidence submitted independently to  the Commission prior 

to the start of the evaluation exercise; 

  Other relevant evaluations and Fitness Checks carried out by the Commission, as 

referenced. 

62 

 
 
 
 
 
Annex 2: Stakeholder consultation 

Prior  to  the  start  of  the  supporting  study,  a  consultation  strategy  was  developed,  and 
stakeholders  were  mapped  to  identify  relevant  groups  and  to  identify  suitable 
consultation  activities  to  reach  out  to  these  groups.  A  draft  consultation  strategy  was 
published in the FCM Evaluation Roadmap. This was the first step of the consultation in 
order to receive feedback on the general consultation approach to the evaluation. A total 
of 26 stakeholders responded, including business organisations and NGOs, mostly related 
to issues with the legislation. 

The  objective  of  the  consultation  was  to  collect  information,  data,  knowledge  and 
opinions.  Many  participants  of  the  consultation  shared  their  experiences  with  the 
implementation  of  the  regulation  and  provided  additional  supporting  evidence. 
Information  was  collected  on  all  five  evaluation  criteria:  effectiveness,  efficiency, 
relevance, coherence, and EU added-value. The main consultation activities consisted of 
the following: 

  A 12-week internet based public consultation took place 11 February 2019 – 6 
May  2019  to  ensure  transparency  and  accountability  and  gave  all  interested 
parties the possibility to contribute. The questionnaire was made available in all 
official EU languages; 

  An SME panel consultation also took place 25 February 2019 – 20 April 2019 
which collected the views of micro, small and medium enterprises (SMEs) on the 
FCM legislation; 

  Interviews  were  undertaken  with  various  key  stakeholders  and  represented  a 
main data collection source for the study. Approximately 40 organisations from 
consumer 
Member  States’ 
organisations), EU professional associations and experts were contributed to help 
build a comprehensive picture of the functioning of the FCM legislation; 

authorities,  NGOs 

competent 

(including 

  Six Focus Groups were organised aimed at gathering views from actors who are 
involved  in  the  implementation  of  the  provisions  of  the  FCM  Regulation, 
including representatives from Member States’  competent authorities as  well as 
Commission  policy  officials.  The  groups  focussed  on  various  topics  ranging 
from  enforcement  and  official  controls  of  the  legislation  through  to  risk 
assessment, risk management approaches and coherence with other legislation; 
  A number of  case studies  were also  carried out, which fed into the  analysis  of 
the  evaluation  questions,  providing  illustrations  of  specific  and  real-life 
situations.  These  included  applications  for  EU  authorisation  of  substances, 
impacts of the EU legislation on SMEs and effects of national legislation in place 
of EU-specific rules. 

  Two workshops also dovetailed the consultation activities, the first to introduce 
the process to stakeholders and the second to conclude it. All main stakeholders 

63 

 
 
 
attended  including  profession  business  associations,  NGOs,  Member  States’ 
competent authorities, scientific experts and other professionals involved in FCM 
regulatory compliance. 

Public consultation40 

The  public  consultation  ran  on  the  Europa  website  from  11  February  2019  to  6  May 
2019. It was open to any interested individual and available in the 24 official languages 
of the EU. The consultation targeted citizens, experts and people with prior knowledge of 
the  FCM  legislation  within  and  outside  the  EU.  The  final  number  of  responses  to  the 
public consultation was 503.  

The public consultation questionnaire was structured into three sections. The introduction 
section  explored  the  general  information  of  the  respondent.  Part  I  of  the  public 
consultation was addressed only to citizens, while Part II was targeted at experts or those 
with  prior  knowledge  of  the  FCM  legislation  and  working  in  the  field.  A  factual 
summary report was prepared and published in July 2019149.  

Respondents  live in  more than 27 countries. The majority of replies were submitted by 
respondents  from  Belgium  (74  responses  that  correspond  to  15%),  followed  by  France 
(13%) and Germany (13%) (figure 1 of the factual  summary report). Of  all the replies, 
5% are from respondents in non-EU countries (Norway, Switzerland, Other). Out of 503 
respondents, 97 are registered in the Transparency Register. 

Overall, citizens represented the largest number of respondents to the public consultation 
(219;  44%),  followed  by  businesses  (204;  41%)  and  public  authorities  (37,  7%). 
Concerning  the  distributions  of  the  organisations  by  size,  most  organisations  identified 
themselves  as  “Large”  (35%,  98),  followed  by  “Medium”  (23%,  64),  Micro  (22%,  61) 
and “Small” (20%, 56). 

The first part of the public consultation targeted citizens (both EU and non-EU). Citizens 
were  asked if they trust  the safety of food contact  materials,  including food packaging, 
kitchenware, and tableware, sold in the EU (figure 4 of the factual summary report). The 
responses  show  a  high  level  of  trust.  Most  citizens  trust  the  safety  of  FCMs  to  a 
reasonable (38%, 84 respondents) or to a large extent (35%, 76 respondents). Only 4% (8 
respondents) of citizens do not trust the safety of FCMs sold in the EU. 

Despite high trust in the safety of FCMs on the EU market, out of 210 respondents, most 
EU citizens responding (66%) do not know which authority is responsible for addressing 
complaints in cases of concerns about the safety of FCMs. Regarding citizens’ perception 
of the development of food safety, 60% of EU citizens believe that the level of safety of 

149 https://ec.europa.eu/food/system/files/2019-07/cs_fcm_20190616_summary-report.pdf  

64 

 
 
 
                                                 
 
food packaging sold in the EU has increased over the last 10 years (figure 5 of the factual 
summary report). Only 10% of respondents believe that the safety has decreased. 

56.4%  of  responses  received  to  the  public  consultation  were  from  experts.  Within  the 
group  of  experts,  businesses  represent  the  largest  group  of  respondents  (72%).  Besides 
businesses, this section of the consultation received contributions from public authorities 
(13%), NGOs (7%) and other experts (8%).  

On  average,  71%  of  respondents  agreed  that  the  scope  of  the  FCM  Regulation  is 
generally clear and they indicated that it is obvious whether a product is an FCM or not 
(figure 6 of the factual summary report). NGOs are slightly less positive as majority of 
NGOs  neither  agreed  nor  disagreed  with  the  statement  (58%).  Generally,  experts 
consider the definitions provided by the FCM Regulation as sufficient and clear (figure 7 
of the factual summary report). Majority of NGOs (89%), however, perceived the current 
definitions provided by the legislation as not sufficient.  

Moreover, results show that the majority of businesses (71%) believe that in general it is 
not  possible  to  demonstrate  compliance  with  the  general  safety  requirements  set  out  in 
Article 3 of the FCM Regulation without having access to significant resources.  

Finally, the majority of  businesses, NGOs and public authorities are aware that the EU 
FCM  legislation  presents  contradictions,  gaps,  overlaps  and  inconsistencies.  A  large 
majority of respondents  (94% of the total number of respondents,  across all categories) 
indicated  that  more  harmonisation  at  EU  level  is  desirable,  compared  to  individual 
Member State legislation. 

SME Panel consultation100 

701 SMEs from 21 Member States provided their input via a dedicated survey. A factual 
summary  report  was  prepared  and  published  in  July  2019.  The  majority  of  the 
respondents  originate  from  four  Member  States:  Poland  (161  SMEs),  Italy  (103), 
Romania  (86)  and  France  (81).  Four  types  of  companies  were  involved  in  the  survey: 
self-employed  (45  replies  representing  7%  of  the  total  number  of  responses),  micro 
enterprise (223 replies, 33% of the total), small enterprises (212 replies, 31% of the total) 
and medium-sized enterprises (195 replies, 29% of the total). 

The  largest  number  of  SMEs  that  responded  to  the  survey  declared  to  be  active  in  the 
plastics, and paper and board industry (respectively, 67 and 64% of SMEs), followed by 
the glass, and metals and alloys industry (34 and 25%)150. Respondents were also asked 
to  classify  the  sector  in  which  they  operate.  A  majority  of  SMEs  that  replied  to  the 
questionnaire classified themselves as food business operator - processor or manufacturer 

150 Multiple answers possible 

65 

 
 
 
                                                 
 
of  food  products  (42%).  The  second  largest  sector  in  which  SMEs  responding  to  the 
survey were active is as manufacturer of final articles or convertor (19%). 

Participants  were  asked  questions  regarding  their  familiarity  with  the  FCM  Regulation. 
In  total,  the  38%  of  the  SMEs  declared  to  be  fairly  familiar  with  general  safety 
requirements  of  the  food  contact  material  legislation,  24%  very  familiar,  22%  a  little 
familiar and 12% not  at  all familiar. Overall, 48% of SMEs indicated that  they did  not 
experience any difficulties in complying with the FCM legislation or in selling FCMs on 
the EU market in the past. 21% of respondents reported having encountered difficulties 
to comply with the regulation (9% rarely, 9% occasionally and 3% frequently).  

Regarding  the  administrative  costs  stemming  from  the  FCM  Regulation  for  SME 
businesses, 79% of respondents  indicated that  the FCM  Regulation represents less than 
2% of their total administrative costs. The overall administrative burden stemming from 
the  FCM  Regulation  appears  to  be  rather  small  (none  or  less  than  1%)  across  all  SME 
types. 

On average, 39% of respondents believe that the needs of their business are sufficiently 
addressed (‘fairly’ to ‘very well’) by the current FCM Regulation. The results show that 
medium-sized enterprises are slightly more positive (50% ‘fairly’ to ‘well’) than smaller 
businesses.  When  looking  at  the  needs  of  different  types  of  businesses,  47%  of  ‘Food 
companies’ and 46% of ‘multi-stage entrepreneurs’ believe that their business’ needs are 
sufficiently reflected by the current FCM Regulation. This number is slightly lower for 
FCM providers with 37%.  

Finally,  a  large  majority  of  respondents  indicated  that  more  harmonisation  at  EU  level 
would  ensure  better  functioning  of  the  EU  internal  market  and  could  help  to  achieve 
higher  and  more  uniform  safety  standards  across  Member  States  (respectively,  74  and 
65%). 

Focus groups151 

Six Focus Groups were organised in the context of this study, aimed at gathering views 
from  representatives  from  Member  State  competent  authorities,  the  Commission,  and 
policy officials  from  competent  authorities  and inspectors from  enforcement  authorities 
who are involved in the implementation of the provisions of the FCM Regulation. These 
are published on the evaluation webpage. The six topics covered were: 

1.  Enforcement of the FCM legislation 

151  Documents  that  were  used  or  produced  during  some  Expert  Working  Groups  of  the  Member  States  on  FCM  to 
support 
evaluation  webpage: 
https://ec.europa.eu/food/safety/chemical-safety/food-contact-materials/policy-initiatives/evaluation-eu-
rules_en  

published 

activity 

group 

focus 

some 

the 

the 

on 

of 

is 

66 

 
 
 
                                                 
 
A  focus  group  on  enforcement  directly  involved  enforcement  activities  staff,  such  as 
inspectors  and  laboratory  officials.  Participants  highlighted  that  the  FCM  legislation 
generally enables the authority to perform official controls on FCMs. However, there are 
several limitations and pitfalls that limit the effectiveness of the enforcement by Member 
States. Firstly, FCMs subject to specific EU measures (plastics in the first place) appear 
to be the most controlled sectors, in that precise limits are available for inspectors. On the 
other hand, non-harmonised sectors tend to be less subjected to control. 

Other issues mentioned by participants were a general and widespread lack of resources, 
different  backgrounds  of  inspectors,  language  barriers  in  the  documentation  (both 
provided  by  business  operators  and  legal  texts)  and  difficulties  in  controlling  imported 
FCMs  (including  control  of  GMP).  Finally,  there  is  a  consensus  as  regards  the 
effectiveness of the JRC guidelines on kitchenware. 

2.  Official Controls in Member States 

This workshop aimed at discussing findings and issues identified in the course of recent 
audits and to discuss common problems, good practices and methods for official controls 
in the FCM sector. The participants were asked to validate some of the findings from the 
public  consultation.  In  the  context  of  such  consultation  activity,  competent  authorities 
could  express  their  views  as  regards  the  number  of  controls  performed,  resources  and 
expertise, access to analytical methods and sanctions. Twenty competent authorities took 
part in the public consultation, and the results of five selected questions on enforcement 
were discussed during the workshop. 

Although  not  statistically  significant,  the  exercise  provided  a  useful  qualitative 
assessment of the agreement of the two groups on selected topics. Overall, the results of 
the  group  exercise  largely  overlap  with  those  of  the  public  consultation,  depicting  a 
general  lack  of  resources  for  the  enforcement  of  the  FCM  legislation,  insufficient 
controls and inspections and inconsistencies of sanctions across Member States. 

3.  Internal coherence of FCM legislation and coherence with REACH 

This  focus  group  was  organized  with  the  aim  of  reflecting  on  the  aspects  related  to 
internal  coherence  of  the  FCM  legislation,  as  well  as  coherence  with  REACH.  All 
participants agreed that the separation between risk management and risk assessment for 
FCMs is appropriate and necessary. Aspects related to size and capacity were identified 
as  the  root  causes  for  not  having  risk  assessment  procedures  in  place  in  all  Member 
States.  Broadly  speaking,  risk  assessments  carried  out  at  national  level  are  usually 
aligned with  the work done by  EFSA; however, it has been reiterated that the different 
Member States approaches  should be more aligned with  each other’s and with  EFSA’s 
approach.  On  this  point,  participants  concluded  that  EFSA  could  provide  some 
“guidance” for risk assessment done at Member State level in non-harmonised sectors, to 
enhance alignment.  

67 

 
 
 
As  regards  the  publication  requirements  for  risk  assessments,  most  countries  are  in 
favour of a more transparent approach. EFSA’s approach was considered appropriate by 
some of the participants, but not stringent enough for the others. It was mentioned once 
that  guidance  on  the  risk  assessment  from  OECD  (Organisation  for  Economic 
Cooperation and Development) is incomplete for FCMs. On the coherence with REACH, 
there  was  a  consensus  among  participants  on  the  importance  of  using  data  generated 
under REACH for FCMs [risk assessment]. However, all the groups agreed that the two 
regulatory systems are based on different principles (risk vs hazard based, migration vs 
tonnage) possibly bringing a different endpoint. 

4.  Effects of the lack of harmonisation 

This focus group examined the effects of non-harmonisation and the implications of the 
absence  of  harmonised  measures.  As  regards  the  achievement  of  both  aspects  of  the 
legislation,  there  was  no  consensus  among  participants.  In  fact,  whereas  some 
participants agreed that the lack of EU-specific measures could hamper the achievement 
of both objectives, the rest argued that objectives are met even in the lack of harmonised 
measures,  thanks  to  national  legislation  and  other  tools  like  industry  self-regulation. 
Main  reasons  for  not  having  national  measures  in  place  mentioned  by  participants  are 
linked  to  limited  knowledge,  capacity  and  resources.  This  is  especially  the  case  for 
smaller  Member  States.  Enforcement  in  non-harmonised  sectors  is  perceived  as 
particularly challenging by participants. In fact, if there is no specific legislation in place, 
controls tend to be lax or even absent. In absence of national legislation, Member States 
usually  rely  on  BfR  (German  Federal  Institute  for  Risk  Assessment)  recommendations, 
resolutions  from  the  Council  of  Europe,  the  US  legislation  or  legislation  by  other 
Member States. However, for enforcement purposes, it has been reiterated that is difficult 
to  use  such  recommendations  and  resolutions,  as  they  are  not  “hard  legislation”. 
Moreover, most of the national legislation is available only in national languages, and is 
sometimes not easily accessible and workable for inspectors. 

As  regards  the  application  of  the  mutual  recognition  principle,  participants  showed 
reservation  towards  finding  evidence  that  a  product  is  legally  marketed  in  another 
Member  State,  hence  hampering  the  application  of  the  principle.  As  a  matter  of  fact, 
participants  underlined  that  checking  the  compliance  of  FCMs  in  other  Member  States 
creates  too  much  burden,  due  to  the  issues  discussed  above  (e.g.  language  barrier, 
inspectors not trained in all Member State legislation, difficulty to access the legal text). 

5.  Risk assessment and risk management 

This focus group aimed at discussing risk assessment and risk management procedures at 
EU  and  national  level  with  representatives  from  Germany,  Belgium,  France  and 
Netherlands, as well as with the Commission. As regards toxicological data requirement 
and exposure assessment, EFSA Note for guidance is generally followed in all countries 
participating in the focus group, albeit with some modification on a case-by-case basis.  

68 

 
 
 
The focus  of the risk assessment  has been debated: participants agreed that  more focus 
should be given to the final article, yet recognizing the technical hurdles stemming from 
such  approach.  As  regards  transparency  and  publication  of  risk  assessment  outcomes, 
participants have different  procedures in  place, but  it is  generally recognized that more 
transparency would increase trust in the risk assessment outcome. Limited resources and 
expertise  to  carry  out  risk  assessment  has  been  highlighted  as  a  limiting  factor  for  the 
evaluation and re-evaluation of substances. 

As  regards  risk  management,  timelines  and  procedures  may  differ  among  participants, 
and it has been recognized as a lengthy phase due to the involvement of stakeholders. A 
more effective exchange of information among countries, but also among risk assessment 
and  management  bodies  within  the  same  country  has  been  recognized  as  a  tool  to 
improve effectiveness and efficiency of both processes. 

6.  External coherence of the FCM legislation 

This focus groups explored the coherence of the FCM legislation with officials from the 
Commission, i.e. representatives from DG ENV, DG JUST, DG SANTE and SG.  

The items discussed covered a review of the outcomes of the Public Consultation related 
to  coherence  and  the  overall  coherence  of  the  provisions  of  the  FCM  Regulation  with 
other legislations, with  a review article by article under the point of view of coherence 
(i.e. gaps, inconsistencies with other legislation). 

Results of this focus group fed into the Case study on Coherence, in that the focus group 
represented a substantial basis for the above-mentioned case study. 

Targeted interviews 

Interviews  encompassed  all  relevant  stakeholders  from  EU  Member  States,  as  well  as 
other  relevant  countries  including  Switzerland  and  Norway.  An  overview  of  the 
stakeholders interviewed can be found listed below: 

Stakeholder type 
EU institutions 

International bodies and third countries 

MSCA 

Stakeholder 
1.  EFSA 
2.  ECHA 
3.  China 
4.  Zürich Laboratory 
5.  FDA 
6.  Council of Europe 
7.  Greece 
8.  Ireland 
9.  Netherlands 
10. Belgium 

69 

 
 
 
 
Stakeholder type 

Stakeholder 

FCM associations 

Experts 

NGO 

Compliance laboratories and law firms 

11. Slovakia 
12. France 
13. Italy 
14. Germany 
15. Denmark 
16. CEPE and MPE 
17. Flexible Packaging 
18. FEICA 
19. CEFIC 
20. FEC 
21. MPE + Cross Sector Group 
22. CEPI 
23. EuPC 
24. ECMA 
25. ETRMA 
26. APPLIA 
27. Plastics Europe 
28. SME United 
29. FoodDrinkEurope 
30. Eurocommerce 
31. Laurence Castle 
32. Maria Rosaria Milana 
33. Karla Pfaff 
34. HEAL 
35. BEUC 
36. ChemTrust 
37. Smithers Pira 
38. Intertek 
39. Steptoe 
40. Keller & Heckman 

Overall, 40 interviews have been performed, excluding those performed in the scope of 
the case studies. Questionnaires for interviews have been customised for each interview, 
thus allowing to focus on the most relevant topics for each interview. 

Nine  Member  State  competent  authorities  were  interviewed.  The  lack  of  resources 
allocated to FCMs has been recognised, thus possibly hampering the implementation of 
the  legislation  in  Member  States.  Issues  related  to  enforcement  (e.g.  inspections  and 

70 

 
 
 
  
controls, enforcement of FCMs with no specific EU measures, sanctions, etc.) have been 
extensively  discussed  with  competent  authorities,  as  well  as  the  occurrence  of  national 
legislation and its effects on both the internal market and the protection of human health. 
Differences  in  terms  of  approaches,  resources  and  priority  have  been  identified  among 
Member States. 

Professional associations generally recognised the positive developments brought by the 
FCM  legislation,  especially  in  harmonised  sectors.  However,  business  operators  often 
complained that the lack of harmonisation could represent a burden to companies, due to 
multiple  national  legislation  comply  to.  The  mutual  recognition  principle  has  been  a 
recurrent  topic  for  discussion,  and  business  operators  often  pointed  out  that  such 
principle  is  often  not  applied.  However,  only  a  few  cases  of  non-application  of  the 
principle have been reported during interviews. 

NGOs  interviewed  remarked  that  the  lack  of  harmonised  measures  in  all  FCM  sector 
represents  a  gap  that  negatively  impact  the  protection  of  human  health.  Issues  like  the 
cocktail  effect  and  multiple  sources  of  exposure  have  been  recalled,  as  missing  in  the 
current  approach.  Moreover,  the  need  for  more  instructions  and  information  for 
consumers and information has been mentioned. 

Workshops152 

Two  workshops  were  organised  in  the  context  of  the  study.  The  first  introductory 
workshop was held on 24th September 2018 and it brought together representatives from 
Member  State  and  EFTA  competent  authorities,  the  European  Institutions,  and  policy 
officials from governmental and non-governmental organisations, European Professional 
Associations  and  regulatory  consultancies.  Different  stakeholders  (NGO  and  industry 
representatives)  and  professional  associations  outlined  diverse  positive  and  negative 
aspects  of  the  FCM  legislation.  The  lack  of  harmonisation  was  identified  as  the  main 
issue. Other aspects of the FCM Regulation that should be improved and addressed are 
its coherence with the circular economy initiative and REACH information, the lack of 
resources for FCM controls and the clarity of the analytical methods and tests.  

The second workshop  was held  on 9th  September 2019 and represented an occasion  to 
present  and  discuss  the  preliminary  findings  of  the  draft  final  report  with  relevant 
stakeholders.  Around  140  participants  were  present  at  the  workshop,  including 
representatives  from  19  Member  States  as  well  as  Norway  and  China,  from  the 
Commission  including  the  JRC  (EURL-FCM),  EFSA  and  representatives  from 
professional associations, NGOs and regulatory support businesses. 

152  Documents  supporting  the  workshops  including  a  recording  of  the  inaugural  workshop  can  be  found  on  the 
https://ec.europa.eu/food/safety/chemical-safety/food-contact-materials/policy-
evaluation 
initiatives/evaluation-eu-rules_en  

webpage 

71 

 
 
 
                                                 
 
Overall,  participants  agreed  with  the  preliminary  findings  of  the  study  and  they 
welcomed the conclusions. However, it has been highlighted  that  some  of the numbers 
presented in the efficiency section require additional verification and overall traceability 
of  findings  shall  be  enhanced.  The  workshop  also  represented  a  last  call  for  data  and 
evidence;  as  a  matter  of  fact,  participants  were  given  the  possibility  to  provide  last 
feedbacks both during and in written form after the workshop. 

Case studies153 

Six case studies were performed within the scope of this study, entailing different  data 
collection tools and consultation activities (i.e. interviews, desk research, focus groups). 
Notably,  synergies  have  been  sought  among  case  studies  and  focus  groups,  to  enhance 
triangulation  of  data  and  findings.  As  an  example,  findings  of  the  focus  groups  on 
enforcement and coherence fed into the related case studies. Moreover, inputs from the 
public consultation as well as from the SME survey have been considered.  

Case study “From application to market” 

Two companies were interviewed for this case study. Due to confidentiality matters, the 
identity of the companies is not disclosed. 

Case study “Lack of harmonisation”  

This  case study mainly  relied on desk research.  An interview with  the German Rubber 
Association (Gesamtverband Kunststoffverarbeitende Industrie e.V.) was performed. 

Case study “Compliance along the supply chain” 

For the plastic and paper subcases, a written questionnaire was distributed to individual 
companies  via  the  pertinent  EU  professional  associations.  For  plastics,  this  included 
PlasticEurope and  EuPC (European Plastic Converters Association). 

For the subcase on kitchenware and appliances, a business operator replied to the written 
questionnaire  and  two  professional  associations  were  interviewed  (FEC  (Federation  of 
European  manufacturers  of  Cookware  and  cutlery)  and  APPLiA  (Home  Appliance 
Europe). 

Case study “Enforcement”  

Several  competent  authorities  have  been  consulted  in  the  course  of  these  case  studies 
through interviews as well as a written questionnaire (see focus group on enforcement). 

153  Details  of 

report, 
https://op.europa.eu/en/publication-detail/-/publication/ccbd784d-bc0c-11ea-811c-01aa75ed71a1  

also  published 

to  Ecorys’ 

annex  2 

studies 

case 

are 

in 

available 

at 

72 

 
 
 
 
                                                 
 
Country 

Authorities 

EU 

Belgium 
Croatia 
Denmark 

Germany 
Greece 
Hungary 
Ireland 

Federal Public Service/Health, Food chain safety and Environment 
Ministry of Health/Directorate of Sanitary Inspection 
Danish Veterinary and Food Administration (DVFA) 
Council of Europe, European Directorate for the Quality of Medicines & 
HealthCare (EDQM) 
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) 
Hellenic Food Authority (EFET) 
National Food Chain Safety Office 
Food Safety Authority of Ireland 
Ministry of Health/Direzione generale per l'igiene e la sicurezza degli 
alimenti e la nutrizione 
Ministry of Health/Nutrition and Physical Activity Division 
Chief Sanitary Inspectorate 
Agencia española de Consumo, Seguridad alimentaria y Nutrición 
(AESAN) 
Switzerland  Kantonales Labor Zürich 
UK 

Lithuania 
Poland 

Fera Science 

Spain 

Italy 

Case study “Small and Medium Enterprises” 

Two SMEs were interviewed in the context of this case study. Findings from interviews 
have been complemented with inputs from the SME survey 

Case study “Coherence of the FCM Legislation” 

Inputs for this case mainly came from desk research, inputs from the public consultation 
and the related focus group with participants from DG ENV, DG JUST, DG SANTE and 
SG. Inputs from DG GROW were also taken into account. 

73 

 
 
 
 
 
Annex 3: Methods and analytical models 

A detailed description of the methods used to derive cost and benefit estimates made for 
this  evaluation  have  been  published  as  part  of  the  supporting  study  (Ecorys  study)  as 
Annex  3  Methodological  Annex  and  Quantification  of  costs154  and  Annex  4 
Methodological Annexes - Composite Index155. 

Quantification of costs 

Due  to  data  limitations,  the  use  of  different  estimation  techniques  was  necessary.  The 
combination  of  a  bottom-up  and  top-down  approach  to  assess  costs  for  businesses  was 
applied. 

For the bottom-up approach, the Standard-Cost model was used. While the main purpose 
of  the  model  is  to  assess  administrative  costs,  its  core  formula  and  elements  were 
applicable to any type of direct costs.  

𝐶𝑜𝑠𝑡 =   ∑ 𝑃 ∗  𝑄 

According to the core equation of the model, costs are the sum of all prices (P) times the 
quantity or number (Q) by which these prices occur. Where sufficient data was available, 
this equation is used to estimate costs linked to the FCM legislation. 

As data availability did not always allow to assess costs this way, a top-down approach 
was also applied. This usually tried to derive the costs linked to FCM legislation from a 
cost estimate that was already available from previous research. The analysis then tried to 
assess the share of costs that could be linked to FCM legislation.  

𝐶𝑜𝑠𝑡 =   𝐶𝑅 ∗ 𝑆𝐹𝐶𝑀 

The  costs  are  the  product  of  reported  costs  (𝐶𝑅)  multiplied  by  the  share  of  these  costs 
attributable  to  the  FCM  legislation  (𝑆𝐹𝐶𝑀).  This  share  was  obtained  from  research, 
interviews  with  stakeholders  and  other  consultation  activities,  notably  the  surveys  and 
case studies. 

The  assessment  of  costs  was  undertaken  for  different  industry  sectors  (plastics,  glass, 
ceramics, others) and looked in particular at the following cost categories:  

  Compliance costs  
 

Implementation costs  

154 https://data.europa.eu/doi/10.2875/045961  
155 https://data.europa.eu/doi/10.2875/028503  

74 

 
 
 
 
 
 
 
 
 
 
 
                                                 
 
  Dossier preparation  
  Administrative costs  

Composite index 

Benefits were mostly not quantifiable in a systematic and uniform manner in the present 
context. Product and substance specific studies did not offer possibilities for meaningful 
generalisations  that  would  clearly  link  changes  to  the  FCM  Regulation.  However, 
(mostly)  qualitative  information  was  available  in  audits  reports,  research  reports  and 
institutional  memories.  These  were  combined  and  the  resulting  qualitative  information 
and existing quantitative data were aggregated through a set of composite indices. 

The regulation has two key objectives:  

1) Protect consumer health and the interests of consumers, and  
2) Facilitate the functioning of the single market.  

The  composite  index  was  used  to  get  a  better  understanding  of  the  first  of  the  two 
objectives, which forms the upper level of the composite indices. A second level is made 
of sub-indices. These were derived from the intervention logic and a clear definition of 
the  ideal  implementation  of  the  FCM  Regulation.  Finally,  each  sub  index  was 
constructed from a set of specific criteria. 

The criteria were used as proxies to measure beneficial effects of the  regulation.  Based 
on  information  available  from  reports  and  consultation  activities,  a  score  was  assigned 
for each of the criteria. Based on this, weighted scores were generated per Member State 
per  sub-index  and  composite  index.  This  approach  allows  a  detailed  assessment  of  the 
performance of individual Member States to identify the benefits of the FCM Regulation 
as well as areas where the regulation did not deliver as expected. 

Three factors contributed to the protection of consumer health: prevention, controls, and 
reaction. These three factors formed the sub-indices for this objective and could be split 
into  several  criteria.  Preventive  factors  were  the  existence  of  a  positive  list  that  only 
authorised  the  use  of  substances  proven  not  to  be  harmful  as  well  as  authorisation 
mechanisms that test substances for their properties. Aspects linked to the enforcement of 
the  FCM  Regulation,  namely  controls  helped  to  ensure  that  industry  is  compliant. 
Mechanisms  to  swiftly  react  to  identified  risks  to  consumer  health  also  contributed  to 
ensure the benefits of the FCM Regulation. 

The analysis was performed for each Member State. The analysis and aggregation of the 
composite indices consisted of several steps: 

Step 1: Scoring criteria 

A  reasoned  score  was  attributed  based  on  the  operationalisation  of  the  criterion.  The 
judgement was based on the evidence collected from the specified sources. Scores were 
in the range between 0 and 5. If there was no information available for a given criterion, 

75 

 
 
 
 
 
 
 
no  value  is  assigned,  and  the  criterion  is  taken  out  of  the  assessment.  Member  States 
where information is very limited were excluded from the analysis. 

Step 2: Weighting of scores 

The formula used to calculate the weighted country indices: 

𝐼𝑖 = ∑ 𝐶𝑖𝑛𝑀𝑖𝑛 

I denotes the corresponding index, C the criterion, M the multiplier, i the Member State 
and n the ID of the criterion. 

Step 3: Interpretation of scores 

The weighting of sub-indices yielded the final index value per Member State. The higher 
the  final  score,  the  greater  the  benefits  of  the  regulation  were  expected  to  be.  A  high 
score indicated that the regulation contributed significantly to the protection of the health 
of consumers, while a value of 0 indicated that the regulation had not generated benefits 
in  the  particular  country.  A  score  of  at  least  70%  of  the  possible  score  was  considered 
“good”. A score below 60% suggested that the benefits for human health are limited. 

76 

 
 
 
 
 
 
 
 
Annex 4: Overview of costs and benefits identified in the evaluation 

Citizens/Consumers  

Businesses 

Administrations 

Qualitative 

Quantitative/m
onetary 

Qualitative  Quantitative/moneta

Qualitative 

Quantitative/monetary  

ry  

Benefit: 
human 
health 

health 
from 
in 
to 

Continual 
benefits 
reduction 
exposure 
hazardous 
substances  via  food, 
expected  

to 
Not  possible 
quantify  but 
for 
certain  substances 
likely  to  be  in  the 
of 
magnitude 
hundreds 
of 
millions of Euros 

Benefit: 
Dossier 
preparation 

savings  by 
level 

Costs 
having  EU 
authorisation  

Cost:  FCM  Annual 

costs 

to   

Increased 
legal 
certainty 
and 
EU trade 

intra-

on 

Based 
the 
average  number  of 
assessments 
risk 
needed  at  national 
level,  EUR  162,000 
per  dossier  or  EUR 
15.4  million  2014  - 
2018 

Enhanced 
cooperation  and 
of 
exchange 
information 
among competent 
authorities  in  the 
Member States 

Compliance 

costs   

Between  EUR  450,000 
and EUR 1.2 million per 
year  for  Member  States 
who 
otherwise 
undertake their own risk 
assessment work 

77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
plastics 
industry 

plastic 
businesses 

FCM 

Cost:  FCM 
businesses 

Annual  costs  to  all 
FCM businesses  

Cost: 
Controls and 
inspections 

costs 

Annual 
to 
Member  States  for 
controls 
and 
inspections, 
expected 

Cost 
EFSA 

for 

cost 

Annual 
for 
EFSA  to  undertake 
risk assessments 

Cost for EC 

Annual  cost  for  risk 
and 
management 
technical support 

Citizens/Consumers  

Businesses 

Administrations 

Qualitative 

Quantitative/m
onetary 

Qualitative  Quantitative/moneta

Qualitative 

Quantitative/monetary  

ry  

(dossier  preparation, 
testing,  GMP)  up  to 
~ EUR 650 million 
Administrative  costs 
up to ~ EUR 230 

~ EUR 3.1 billion 

Up  to  EUR  23  million, 
including staff costs and 
resources  to  undertake 
controls 

~ 
EUR 
including staff costs 

600,000, 

~  EUR  2.3  million 
including 
staff  costs, 
and 
activities 
BTSF 
operational costs by JRC 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 5: Supporting tables and diagrams 

Figure 6: Simplified structure of the organisation of an FCM supply chain 

Figure  7:  Representation  of  a  Multi-material  Multi-layer  presented  by  the  Industry 
Cross Sector Group. 

79 

 
 
 
 
 
 
 
Figure  8:  GB  9685-2016  Standards  for  Uses  of  Additives  in  FCM.  Updates  on  FCM 
Standards: Developments in China. 5th Symposium for safety of food contact material 

Figure 9: SME opinion regarding harmonisation at EU level 

To which extent do you think more harmonisation at EU level would 
help to:

Achieve higher safety standards across MS

43%

30%

6%

2%

19%

Ensure functioning of the internal market

31%

34%

10%

4%

21%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

To a large extent

To a reasonable extent

To a small extent

No impact

Don't know

80 

 
 
 
 
 
 
 
 
 
 
 
Table 2: EU manufacturing sales per annum of different packaging materials, cutlery 
and FCM machinery and revenue share by size of enterprise. SME shares may also 
include micro enterprises. JRC ‘baseline’ study. 

Material 

EUR  
Million  

Plastic 
Paper 
Glass 
Metals 
Printing inks 
Cork 
Adhesives 
Ceramic & porcelain 
Wood 
Rubber 
Varnishes & coatings 
Cutlery 
General purpose 
machinery 
Special purpose 
machinery 

30 029 
26 713 
7157 
7068 
1300 
1216 
1200 
915 
713 
500 
400 
202 

11 134 

12 572 

% EUR  
Small 
enterprises   
26 
30 
13 
16 
6 
69 
35 
43 
74 
35 
5 
50 

24 

27 

% EUR  
Medium 
enterprises 

% EUR  
Large 
enterprises  

Source 

41 
35 
19 
42 
14 
21 
15 
19 
17 
15 
0 
30 

33 

32 

33  Pira 2013 
35  Pira 2013 
68  Pira 2013 
26  Pira 2013 
80 
EuPIA 
10  Pira 2013 
FEICA 
50 
38  Pira 2013 
9  Pira 2013 
50  ETRMA 
CEPE 
95 
20  Pira 2013 

43  Pira 2013 

41  Pira 2013 

81 

 
 
 
 
Table 3: Overview of material specific national rules and tools. From JRC ‘Baseline’ report6. CoE means Council of Europe. 

Material 

Positive List 

Negative 
list 

SML 

OML 

Limits for 
substance quantity 

Details 
on GMP 

DoC & 
supporting 
docs 

Basis for 
sanctions 

Basis for 
enforcement 

Adhesives 

DE, ES, FR, HR, 
IT, NL 

Ceramics 

Cork 

CoE, CZ, FR, NL, 
SK 

CoE, 
(NL) 

Glass 

BE, (IT), SK 

(HR), NL 

AT, CZ, DE, DK, 
FI, HR, NL, NO, 
PL 

CoE, CZ, NL, SK 

BE, BG, CH, 
CoE, CZ, DE, 
DK, FR, HR, IT, 
NL, NO, SK 

ES, HR 

ES, HR 

DE, ES, FR, HR, NL 

ES 

ES, HR, IT 

NL 

CoE, HR, 
NL 

CoE, SK, NL 

BE, NL 

FR, (NL) 

(SK) 

IT 

AT, CZ, NO 

CZ, DE, NL 

Ion 
exchange 
resins 

CoE, ES, FR, NL 

CoE, ES, NL 

CoE, ES, NL  CoE, ES, FR 

CoE 

NL 

ES 

CoE, (ES) 

Metals and 
alloys 

CZ, EL, FR, IT, 
NL, SK 

AT, CH, 
HR 

AT,(CH), CoE, 
FR, HR, IT, NL, 
NO, Norden  

FR, NL 

AT, BE, CH, CoE, 
CZ, EL, FR, HR, IT, 
NL, SK 

(IT) 

CoE, FR, IT 

IT 

Multi-
materials 

Paper and 
Board 

Printing 
inks 

FR, IT, Norden 

Norden 

FR, IT 

FR, IT 

FR, IT, Norden 

BE, CoE, CZ, 
DE, (EL), FR, IT, 
NL, Norden, SK 

CoE, DE, 
EL, (HR), 
Norden 

BE, CoE, DE, EE, 
FR, HR, IT, NL, 
Norden,PL, SK 

BE, DE, FR, 
NL, Norden 

BE, CoE, CZ, DE, 
EL, FR, HR, IT, NL, 
Norden, SK 

(HR), 
Norden 

IT, Norden 

IT 

CH, CoE, 
DE_draft, FR, 
NL, SK 

CoE, CZ, 
HR 

CH, CoE, DE, 
(DE_draft), FR, 
NL 

FR 

CH, CoE, CZ, FR, 
(HR), NL, RO, SK 

DE_draft, 
FR, IT, 
Norden, RO 

DE_draft, 
IT 

CoE, Norden 

82 

CoE, HR 

BG, CZ, DE, 
DK, FR, IT, 
NO 

AT, CoE, 
FR, HR, IT, 
NO 

FR 

CoE, DE, 
EE, FR, HR, 
IT, Norden, 
PL 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Material 

Positive List 

Negative 
list 

SML 

OML 

Limits for 
substance quantity 

Details 
on GMP 

DoC & 
supporting 
docs 

Basis for 
sanctions 

Basis for 
enforcement 

Rubber 

Silicones 

CoE, CZ, DE, ES, 
FR, HR, IT, NL, 
SK 
CH, CoE, CZ, 
DE, ES, FR, HR, 
IT 

CZ, DE, 
HR, SK 

AT, CoE, CZ, 
DE, ES, FR, HR, 
NL, RO, SK 

CoE, CZ, 
HR 

CH, CoE, CZ, 
DE, ES, FR, IT 

Varnishes 
and 
coatings 

CoE, CZ, DE, EL, 
ES, FR, HR, IT, 
NL, SK 

FR, HU, 
HR 

BE_draft, CH, 
CoE, CZ, DE, EL, 
ES, FR, HR, IT, 
NL, 

Wax 

Wood 

DE, ES, (FR), NL 

ES 

FR, NL 

FR, (NL) 

FR, HR, NL 

CoE, DE, 
ES, FR, HR, 
NL, RO 
CH, CoE, 
DE, ES, FR, 
HR, IT 
BE_draft, 
CoE, EL, ES, 
FR, HR, IT, 
NL 

ES 

NL 

AT, CoE, CZ, DE, 
ES, FR, HR, IT, NL, 
SK 

CH, CoE, CZ, DE, 
ES, FR, HR, IT 

BE_draft, CoE, CZ, 
DE, EL, ES, FR, IT, 
NL, SK 

CH, DE, ES, (FR), 
NL 
FR 

CoE 

FR, IT, RO 

ES 

AT, CoE, 
DE, (ES), 
FR, HR, IT 

ES 

(ES), FR 

CoE 

BE_draft, EL  ES, IT 

BE_draft, 
DE, (ES), 
HR, IT, NL 

ES 

(ES) 

FR, HR 

83 

 
 
 
 
 
 
 
 
 
 
 
Table 4: Common substances regulated by different Member States: JRC ‘baseline’ 
study. 

Material 

Adhesives 
Printing inks 
Ion exchange resins 
Varnishes 
Cork/wood 
Paper & board 
Rubbers 
Silicones 

of 

No. 
substances 
regulated in national rules 
1323  
5214 
387  
1721  
168 
1710  
1028 
336 

Substances  in  common 
≥ 3 Member States 
9 (0.7%) 
34 (0.6%) 
0 
88 (5%) 
19 (11%) 
147 (9%) 
185 (18%) 
37 (11%) 

Table 5: Overview of country performance on the composite index on health benefits 
+: Score above 70%; 0: Score above 60%; -: Score below 60% of potential score 
*Assessment based on a limited number of data points. From Ecorys report, 
methodological annex 4, composite index95. 

Country 
C 1 
C 2 
C 3 
C 4 
C 5 
C 6 
C 7 
C 8 
C 9 
C 10 
C 11 
C 12 
C 13 
C 14 
C 15 
C 16 
C 17 
C 18 
C 19 
C 20 
C 21 
C 22 
C 23 
C 24 

Prevention 
+ 
+ 
- 
- 
- 
+ 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
+ 
- 
- 
- 
- 

Control 
+ 
- 
+ 
0 
+ 
+ 
0 
+ 
- 
- 
+ 
+ 
0 
+ 
+ 
+ 
0 
+ 
+ 
0 
- 
- 
+ 
+ 

84 

Reaction 
0 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ 

Score 
72% 
65%* 
66% 
70% 
74% 
76% 
63% 
72% 
44%* 
57% 
71% 
64%* 
62% 
62%* 
75% 
71% 
53%* 
78% 
73% 
72% 
65% 
44%* 
70% 
79% 

 
 
 
 
Country 
C 25 

Prevention 
+ 

Control 
+ 

Reaction 
+ 

Score 
80% 

Table 6: Estimated cost reduction for industry due to harmonised risk assessments 
Source: Ecorys. Data on the number of applications for specific measures submitted to 
EFSA is taken from EFSA’s Register of Questions from 2014 – 2018. From Ecorys 
report, methodological annex 3, quantification of costs106. 

Avg. admin cost of dossier 

Total number of applications 

Multiplier 

Total cost 

Scenario 1 

Scenario 2 

Scenario 3 

EUR 60 000 

95 

2 

3.7 

1 

EUR 5.7 million  EUR 11.4 million  EUR 21.1 million 

Total cost savings 

None 

EUR 5.7 million  EUR 15.4 million 

NB.  Scenario  1  represents  the  administrative  cost  for  submission  of  one  dossier,  either  to  a 
Member  State  or  in  the  case  of  substances  used  in  plastic  FCMs,  to  EFSA.  The  cost  is  the 
same  in  cases  where  one  Member  State  assesses  and  authorises  a  substance  and  all  other 
Member States accept that assessment, including those who do not have specific rules on the 
substance. No specific examples were identified in this scenario. The total administrative cost 
of submitting the 95 dossiers to EFSA for substances used in plastic between 2014 and 2018 
is estimated to amount to approximately EUR 5.7 million.  

Scenario 2 represents  the situation where industry  must submit  data for the assessment of a 
substance  twice,  for  two  Member  States  to  authorise  the  same  substance.  In  this  case,  the 
administrative  costs  are  therefore  double  and  costs  savings  amount  to  EUR  60,000  per 
substance assessment or EUR 5.7 million over the period 2014 – 2018 for 95 substances by 
having  one  EU  risk  assessment.  Scenario  3  uses  the  average  of  3.7  Member  States  who 
perform  risk  assessments  per  material  group  and  therefore  represents  the  average  scenario 
when applicants wish to market their product in the EU, in the absence of EU-specific rules 
(i.e. for non-plastics). Administrative costs for submitting a dossier are assumed to multiply 
by 3.7 and costs savings amount to EUR 162,000 per substance or EUR 15.4 million over the 
period 2014 – 2018 for 95 substances by having one EU risk assessment. 

Table 7: Overview of estimated cost savings for Member States’ competent authorities 
for risk assessments. From Ecorys report, methodological annex 3, quantification of 
costs106. 

Scenario 1 

Scenario 2 

Scenario 3 

Number of risk assessments  

1 

2 

3.7 

Total costs for authorities 

EUR 450 000 

EUR 900 000 

EUR 1.6 million 

Cost savings 

None 

EUR 450 000 

EUR 1.2 million 

85 

 
 
 
 
 
 
Table 8: Overview of estimated costs and extrapolated estimates for the industry 
overall. *For cork, wood, and machinery, it was assumed that compliance costs amount 
to 2% of turnover. **JRC baseline Report. From Ecorys report, methodological annex 
3, quantification of costs102. 

Sector 

Turnover
** 

Compliance costs  Administrative 

Total costs 

costs 

EUR 
million 

Share  of 
turnover 

EUR 
million 

Share  of 
turnover 

EUR 
million 

Share of 
turnover 

EUR 
million 

Plastics 

30 000 

2.1% 

650 

0.9% 

230 

3% 

878 

Ceramics 

915 

0.001% 

0.01 

0.009% 

0.08 

0.01% 

0.09 

Glass 

Adhesives 

Printing inks 

20 000 

1450  

1700  

Metals & alloys 

10 000  

Paper & board 

26 713  

Rubber 

Coatings 

500  

400  

Other sectors* 

25 600 

0.1% 

2.0% 

10.0% 

5.0% 

4.0% 

2.0% 

2.0% 

2.0% 

7.5 

29  

170  

500  

1069  

10  

8  

512 

0.04% 

4 

0.1% 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

11 

29  

170  

500  

1069  

10  

8  

512 

Total 

117 000 

2.5% 

2,955 

N/A 

N/A 

2.7% 

3 187 

Table 9: Overall estimated compliance costs for plastics sector. From Ecorys report, 
methodological annex 3, quantification of costs106. 

Costs 

Lower bound 

Upper bound 

Compliance costs 

154 300 000  

Administrative costs 

58 500 000  

Total 

212 800 000  

Share of turnover 

0.7% 

650 000 000  

227 900 000  

877 900 000  

2.9% 

86 

 
 
 
 
 
 
 
 
Table 10: Overview of strategies to calculate dossier costs. *Surrogate data from 
PlasticsEurope. From Ecorys report, methodological annex 3, quantification of costs102. 

Source 

PlasticsEurope  Case study 1  Own computation  Expert example 

Cost items 

EUR 

EUR 

EUR 

EUR 

Toxicity testing 

Lower bound 

150 000  

Central estimate 

21 000  

447 000  

50 000  

155 000  

Upper bound 

2 000 000  

1 080 000  

1 750 000  

Analytical testing 

Lower bound 

30 000  

Upper bound 

80 000  

Resources 

Lower bound 

20 000  

Upper bound 

100 000  

Total dossier 

30 000*  

80 000*  

20 000*  

100 000*  

Lower bound 

200 000  

300 000  

71 000  

Upper bound 

2 180 000  

400 000  

1 260 000  

80 000  

100 000  

9000  

50 000  

139 000  

1 900 000  

Table 11: Estimates of costs for compliance activities (excl. dossier preparation) by 
company size. * Since the sample of companies only contained medium and large 
companies, it was necessary to extrapolate estimates for small companies. **Based on 
the number of plastic packaging companies in the EU-28. From Ecorys report, 
methodological annex 3, quantification of costs102. 

Compliance cost 

Small 

Medium 

Large 

Total** 

Establishing GMP 

Min EUR 

Max EUR 

Analytical testing 

Min EUR 

Max EUR 

2000*  

40 000  

40 000  

54 100 000  

23 500*  

100 000  

100 000  

281 300 000  

7500*  

31 000  

64 000  

93 300 000  

31 000*  

100 000  

150 000  

347 100 000  

87 

 
 
 
 
  
  
  
  
  
  
  
 
 
 
Table 12: FTEs and costs per company by size, and total annual costs for industry. 
From Ecorys report, methodological annex 3, quantification of costs102. Weighted 
average labour costs = EUR 35,790 

Administrative costs  Small 

Medium 

Large 

Total 

Numbers 

Min FTE 

Max FTE 

Costs 

Min EUR 

Max EUR 

0.1 

0.6 

0.6 

1 

2.6 

6 

--- 

--- 

3600  

21 500  

21 500  

35 800  

93 100  

58 500 000  

214 700  

227 900 000  

Table 13: Some of examples of substances authorised at national level for rubber FCM 
(Ecorys report). 

Substance 

Acrylic acid 
zinc di(benzothiazol-2-yl) disulphide 
Benzothiazole-2-thiol 
5-vinylnorborn-2-ene 
Dibenzyldithiocarbamic acid, zinc salt 
Dibenzolyl peroxide 
Diphenylamine, styrenated 

Authorisation 

DE, F, I 
DE, F, I, NL 
DE, NL, F 
NL, F 
NL, F 
NL, F 
DE, NL, F 

Table 14: Overall costs of FCM legislation for the EU-28. From Ecorys report, 
methodological annex 3, quantification of costs102 

Lower bound 

Upper bound 

Implementation of EU rules 

EUR 2.4 million 

EUR 3.2 million 

Implementation of national legislation 

EUR 1.3 million 

EUR 1.8 million 

Controls 

Total 

EUR 10.0 million 

EUR 18.0 million 

EUR 13.7 million 

EUR 23 million 

88 

 
 
 
 
 
 
 
 
 
Annex 6: Case examples 

Case example 1 

An example of problems encountered on the scope of FCMs 

The discussion is relevant for both safety as demonstrated by studies showing migration of 
hazardous substances from paper napkins156,157 as well as the functioning of the market. The 
latter  is  exemplified  by  a  case  presented  to  the  Commission  from  a  business  affected  by 
competitors who were not taking steps to ensure that paper napkins were food contact safe. 
In  this  example,  different  interpretations  from  businesses  and  Member  States’  competent 
authorities were therefore demonstrably creating conditions of inequality as regards placing 
FCMs on the EU market. Many examples have been highlighted by businesses and Member 
States in recent years, including questions over the need for compliance documentation for 
plastic table mats as well as more novel products, such as food grade colorants intended to 
be used in homes printers in order to apply patterns or decoration to cakes. 

Case example 2 

An example of deterioration of organoleptic characteristics 

In  2018,  Denmark  performed  sensory  tests  of  drinking  bottles  and  cups  -  22  samples  of 
drinking bottles (for water) and 3 samples of cups. The DVFA enforcement laboratory test 
for  organoleptic  changes  was  based  on  standards  for  testing  (ISO  13302:2003,  Nordic 
Committee on Food Analysis NMKL procedure no. 19). The test conditions (food simulant, 
contact time and temperature) reflect the conditions of use of the material. The result of the 
testing showed deterioration of organoleptic characteristics of water in contact with plastic 
bottles from the Netherlands. This led to withdrawal from the market of the product. 

The  manufacturer  provided  a  DoC  and  results  from  a  sensoric  test  for  three  other  bottles 
(considered  to  be  representative  for  the  tested  bottle).  The  test  method  applied  was 
comparable  to  the  DFVA  test  but  included  5  and  not  8  participants  in  the  panel. 
Furthermore,  the  scale  for  assessing  if  the  product  was  compliant  was  different  from  the 
approach of the DFVA. The manufacturer referred to the Regulation (EC) No 764/2008 on 
the  mutual  recognition  of  goods  lawfully  marketed  in  another  Member  State  and  claimed 
that the lack of a standardised method for testing organoleptic characteristics was creating 
uncertainty. 

Case example 3 

Ageing of the Union list of authorised substances  

The  only  legal  requirement  to  update  assessments  and  authorisations  is  placed  on  industry, 

156 https://www.bfr.bund.de/cm/349/primary-aromatic-amines-from-printed-food-contact-materials-such-as-napkins-or-
bakery-bags.pdf 
157 https://www.tandfonline.com/doi/full/10.1080/19440049.2016.1184493?scroll=top&needAccess=true 

89 

 
 
 
                                                 
 
who must inform the Commission of any new scientific or technical information, which might 
affect the safety assessment of the authorised substance. However, only two such notifications 
have been made to the Commission in recent years whereas scientific information has become 
available on substances such as phthalates and styrene and on which, following requests from 
the Commission, EFSA has given updated opinions.  

Another example is that of ‘untreated wood flour and fibres’ (FCM No 96), which is presently 
authorised as an additive in plastic FCMs. The substance was included in the list of additives 
for plastic FCMs by Directive 95/3/EC158, based on the assumption that it is inert. However, 
recently it has not been possible to establish the basis for this conclusion and doubts could not 
be resolved over which plant species and plant parts may be considered as wood and would 
therefore be in the scope of this authorisation, as well as over the actual inertness of untreated 
wood  flour  and  fibres  when  added  to  a  plastic.  Therefore,  the  Commission  provided  EFSA 
with  a  mandate  to  address  these  questions,  and  to  assess  in  particular  whether  the 
authorisation of untreated wood flour and fibres would still be in accordance with the FCM 
Regulation.  

The  opinion  adopted  by  EFSA  concludes  that  wood  cannot  be  considered  inert  per  se,  and 
considers that presently available information is insufficient to support that the authorisation 
of this substance is in accordance with the FCM Regulation. EFSA also concluded that given 
the chemical differences in composition of wood materials, the safety of migrants from these 
materials must be evaluated on a case-by-case basis, considering beyond species also origin, 
processing, treatment to make it compatible with the host polymer and assessment of the low 
molecular weight constituents migrating into food.  

Case example 4 

An illustration of the NIAS issue 

The issue of NIAS can be illustrated by the historical case of azodicarbonamide (ADC) from 
the  early  2000s.  ADC  had  been  authorised  as  a  blowing  agent  of  PVC  in  Directive 
2002/72/EC159,  the  precursor  of  the  plastics  Regulation.  Prior  to  its  authorisation,  several 
known  degradation  products  of  ADC  had  been  evaluated  for  their  safety.  One  degradation 
product, semicarbazide (SMC) was not known to the evaluators at the time, and therefore it 
was not included in the evaluation. Consequently, when SMC was detected by an enforcement 
laboratory, its origin was not known, which in turn caused concern, including in mainstream 
press160.  This  case  illustrates  the  importance  of  having  available  full  information  - 
communicated by the chemical industry - on the stability and of the reactivity of the starting 
substance for the evaluation of NIAS. If the full pattern of reaction products of ADC had been 
known,  there  would  have  been  no  ADC  crisis.  However,  often  the  formation  of  reaction 
products cannot be anticipated, as it frequently depends on many parameters in the production 
process of polymeric materials. This remains a major obstacle to ensuring compliance of the 
final FCM with Article 3 of the FCM Regulation and therefore hampers the effectiveness of 

158 http://data.europa.eu/eli/dir/1995/3/oj  
159 http://data.europa.eu/eli/dir/2002/72/oj 
160 http://news.bbc.co.uk/2/hi/health/3194284.stm  

90 

 
 
 
                                                 
 
the legislation.  

Case example 5 

Lack of transfer of information in the supply chain 

‘Glymo’ is a substance authorised in plastic FCMs, but its use is severely restricted based on a 
2017 EFSA opinion161 as the substance has genotoxic potential. This means that basic in vitro 
tests  show  it  can  damage  genetic  information  and  may  cause  mutations  leading  to  cancer. 
Under  REACH  this  is  being  further  addressed  in  order  to  conclude  on  the  genotoxicity  of 
Glymo162. 

Glymo  belongs  to  a  group  of  very  similar  epoxy  silanes  and  is  used  to  provide  a  chemical 
bond between inorganic materials and polymers. In the authorised application for plastics the 
substance reacts with the surface of the glass fibres and with the polymer. Therefore, a very 
strong bond is formed between the glass fibre and the plastic. EFSA considered this use safe, 
because  the  residue  of  unreacted  Glymo  on  the  fibre  is  negligible,  and  it  is  added  to  low 
diffusivity plastics. 

However, the publication of the EFSA opinion stimulated awareness of this substance and its 
genotoxic  potential.  There  are  many  more  applications  of  Glymo,  such  as  in  adhesives, 
coatings  and  other  multi  material  materials,  to  bind  a  polymer  to  an  inorganic  substrate. 
However, such use is not automatically safe as it is in the authorised use in glass fibres.  

A meeting between the Commission, Member States and industry on 2 May 2019 confirmed 
wide use of the substance, with migration exceptionally peeking well above its detection limit 
of 10 ppb. On the basis of the presently available information, the migration of the substance 
and  its  reaction  and  decomposition  products  should  be  well  below  0.15  ppb  in  accordance 
with current EFSA guidelines on risk assessment.  

A producer of the substance said it first became aware of its potential genotoxic nature around 
2000, but it only acted recently “on the basis of the EFSA opinion”. Based on the reactions 
from the industrial users of Glymo, sufficient information in the supply chain was lacking. In 
some  cases,  the  users  only  had  just  become  aware  of  its  presence  in  their  products.  The 
example demonstrates a lack of information being passed on in the supply chain. 

Case example 6 

Mutual recognition issues  

  Additional  specific  tests  are  required  in  Italy  to  show  that  FCM  paper  and  board 
comply  with  Italian  legislation,  although  the  supplier  is  able  to  demonstrate  the 
paper  complies  with  rules  in  the  origin  Member  State  and  in  all  other  Member 
States.  The  costs  of  the  testing  amount  to  approximately  EUR  700,  which  is 
relatively  low  for  the  company  involved  but  may  be  prohibitively  high  for  small 
businesses. This example shows that the requirement for additional testing does not 

161 EFSA Journal 2017;15(10):5014; Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for 
use glass-fibre-reinforced plastics in food contact materials (CAS No 2530-83-8, FCM No 01068) 
162 https://echa.europa.eu/documents/10162/928e3cb7-726b-4eae-0888-8b2450b6a02b  

91 

 
 
 
                                                 
 
come directly from the authorities, but rather from the customers of the producing 
company.  As  confirmed  by  an  organisation,  which  represents  large,  medium  and 
small chemical companies across Europe during this study, this is by no means an 
exception. It should be noted that this is not a problem of mutual recognition per se 
since  the  barrier  does  not  result  from  a  Member  State  action  but  from  private 
requirements. 

  Also  in  Italy,  a  laboratory  provided  an  example  of  pans  manufactured  in  the  US, 
which are sold everywhere in EU, but were not approved for sale in Italy pursuant to 
national legislation on metal FCMs. 

  A third example concerns difficulties for a company to place water filter cartridges 
on the Italian market, although they were legally marketed in another Member State. 
A lack of agreed EU rules and diverging standards in Member States increased costs 
for the company to access the Italian market and resulted in  a formal complaint to 
the Commission and legal challenge by a business operator before Italian courts. A 
follow  up  complaint  was  also  made  concerning  information  guidelines  on  water 
treatment systems for human consumption. 

  National rules are a particular challenge for complex and large machines in contact 
with  food.  For  example,  if  a  company  in  Spain  produces  a  rubber  product  (e.g. 
conveyer belt) and delivers it to a machine producer in Italy the national legislation 
of  both  countries  will  have  to  be  respected  when  producing  the  FCM.  However, 
since the final product will be sold in Germany, the rubber composition also needs 
to be compliant with rules in Germany, which may not be known to the producer in 
Spain.  As  consequence,  when  a  Member  State  is  applying  different  rules  in  a 
specific area, it leads to different costs for companies (e.g. test report describing the 
proof of compliance (or DoC) of a certain product with food application purposes). 

 

In Belgium, there is a national legislation on coatings, and it is the responsibility of 
the industry to communicate compliance throughout the supply chain. If the industry 
does not comply with the national legislation and they do not state that they comply 
with  another  Member  State’s  legislation,  then  this  is  considered  a  case  of  non-
compliance. In case that industry complies for instance, with the Dutch legislation, 
the  mutual  recognition  principle  is  applied.  However,  Member  States’  participants 
in the focus groups also shared that it was hard to produce evidence that a product is 
legally marketed in another Member State. 

92 

 
 
 
 
 
 
Annex 7: Overview of main specific measures on FCMs that are 
currently applicable at EU level and their implementation  

Legislation 

Description and state of play on implementation 

Commission 
Regulation  (EC) 
No 2023/2006 

Rules  on  Good  Manufacturing  Practice  (GMP),  including  the  need  for 
quality  assurance  systems,  quality  control  systems  and  documentation. 
Directly applicable to all businesses manufacturing materials and articles in 
the EU from 1 August 2008.  

Commission 
Regulation  (EU) 
No 10/2011  

Commission 
Directive 
2007/42/EC 

Specific  rules  concerning  plastic  FCMs,  including  their  composition, 
testing requirements  and a list of authorised substances to  be used in  their 
manufacture. The majority of the regulation was directly applicable from 1 
May  2011,  but  it  was  an  updated  version  of  legislation  that  had  evolved 
since  1990.  The  regulation  is  regularly  amended  to  authorise  new 
substances,  modify  restrictions  on  existing  substances  or  further  clarify 
rules  or  testing  methods.  The  regulation  is  supported  by  two  guidance 
documents:  EU  Guidance  on  Regulation  (EU)  No  10/2011  and  EU 
Guidance  on  information  in  the  plastics  supply  chain.  These  are  tools 
available  for  both  business  operators  and  Member  State  competent 
authorities that have been translated into all languages of the EU. 

Specific  rules  concerning  regenerated  cellulose  film  (RCF),  which  is 
more  commonly  recognised  as  Cellophane  when  converted  into  film.  The 
Directive,  which  includes  a  list  of  authorised  substances  to  be  used  in  the 
manufacture of RCF is a codification of Commission Directive 93/10/EEC 
and its amendments. This latter directive itself repealed the original Council 
Directive  83/229/EEC,  which  Member  States  were  required  to  implement 
by 1 January 1985. 

Commission 
Regulation  (EC) 
No 282/2008 

Specific rules concerning recycled plastic used as FCM, including a list 
of  processes  authorised  to  carry  out  recycling  of  plastic  for  FCMs.  The 
Commission  is  currently  in  the  process  of  replacing  this  regulation.  Until 
then, processes used for recycling of plastic for use as FCM are subject to 
national rules. 

Commission 
Regulation  (EC) 
450/2009 

inertness.  This  regulation  provides  for 

Specific rules concerning active and intelligent FCM (AIM). Since these 
materials  are  by  their  nature  not  inert,  they  are  exempt  from  the  general 
the 
FCM  rules  concerning 
establishment of a Union list of substances permitted for the manufacture of 
AIM but has not yet been established. Whereas EFSA has assessed several 
applications for such substances, the conversion of this work into an EU list 
of  authorised  substances  requires  additional  consideration  and  currently, 
substances used in AIM are subject to national rules. Some elements of the 
regulation are however applicable, including the need for labelling.  

93 

 
 
 
Legislation 

Description and state of play on implementation 

Council 
Directive 
84/500/EEC 

Commission 
Regulation  (EU) 
2018/213 

Commission 
Regulation  (EC) 
1895/2005 

Commission 
Directive 
93/11/EEC 

Specific  rules  concerning  heavy  metals  from  ceramic  FCMs.  This 
directive  was  introduced  in  the  mid-1980s  and  aims  to  adverse  effects  of 
lead  and  ceramic,  which  can  be  present  in  ceramic  ware  and  transfer  into 
food. Limits were therefore established with test methodology that Member 
States  had  3  years  to  implement.  Recent  opinions  by  EFSA  on  lead  and 
cadmium, indicate a significant reduction in the current limits is required. 

Specific rules on the use of bisphenol A (BPA) in varnishes and coatings 
and  plastics.  BPA  has  been  authorised  for  use  in  plastic  FCMs  since  the 
establishment  of  a  Union  list  of  substances  together  with  an  SML. 
Increasing  scientific  output  on  the  toxicology  of  BPA  and  scrutiny  by 
Member  States  led  to  re-evaluation  work  being  undertaken  by  EFSA  and 
national measures being introduced under Article 18 of the FCM Regulation 
concerning safeguard measures. Regulation (EU) 2018/213 was introduced, 
with the aim of avoiding the barriers on the EU market caused by national 
measures  and  updating  restrictions  and  applying  them  to  varnishes  and 
coatings in recognition of the wide-spread use of BPA in these materials, in 
addition to plastic. 

Specific rules on the use of certain epoxy derivatives in FCMs. Rules on 
the  use  of  certain  epoxy  derivatives  were  first  introduced  in  2002  by 
Directive 2002/16/EC163  to  avoid  risks  to  human health and barriers to  the 
free  movement  of  goods.  Following  an  assessment  by  EFSA,  Regulation 
(EC)  1895/2005  replaced  that  directive.  The  rules  were  updated  and  are 
applicable to plastics, coatings and adhesives and in particular, prohibit two 
substances known as BFDGE and NOGE. 

Specific  rules  on  the  release  of  N-nitrosamines  and  N-nitrosatable 
substances  from  rubber  teats  and  soothers.  These  were  introduced 
following  an  assessment  by  the  then  SCF,  which  identified  that  n-
nitrosamines  and  endogenous  precursors  n-nitrosatable  substances  can 
migrate  from  these  rubber  materials  in  particular,  during  oral  contact. 
Member States were required to implement the directive from 1 April 1994.   

163 http://data.europa.eu/eli/dir/2002/16/oj 

94 

 
 
 
                                                 
 
Legislation 

Description and state of play on implementation 

Commission 
Regulation  (EU) 
No 284/2011  

import  of 
Specific  conditions  and  detailed  procedures  for  the 
polyamide  and  melamine  plastic  kitchenware  originating 
in  or 
consigned  from  China  and  Hong  Kong.  Following  an  increase  in  the 
incidence  of  non-compliance  with  EU  legislation  concerning  certain  types 
of plastic FCMs from China and Hong Kong, this measure was introduced 
to  increase  checks  and  controls  of  such  consignments  entering  the  EU.  It 
was  introduced  under  Article  48  of  Regulation  (EC)  No  882/2004  on 
official  controls,  which  has  since  been  replaced  by  Regulation  (EU) 
2017/625.  The  regulation  requires  Member  States  to  record  and  report  on 
the controls, including rates of compliance, every three months. Two sets of 
related  guidance  have  been 
introduced:  EU  Guidelines  concerning 
Commission Regulation (EU) No 284/2011 as well as Technical Guidelines 
concerning  polyamide  and  melamine,  which  contain  practical  information 
on  sampling,  migration  testing  and  methodologies  prompted  by  the 
introduction of the Regulation (EU) No 284/2011.  

Commission 
Recommendation 
(EU) 2019/794 

This  Recommendation  sets  out  a  coordinated  control  plan  with  a  view  to 
establishing  the  prevalence  of  certain  substances  migrating  from  materials 
and articles intended to come into contact with food. Controls were carried 
out by Member States 2019 – 2020.  

Commission 
Recommendation 
(EU) 2017/84 

This  Recommendation  coordinates  efforts  to  investigate  the  occurrence  of 
mineral oil hydrocarbons in food and in FCMs. 

95 

 
 
 
 
 
Annex 8: Intervention logic 

FCMs  are  not 
inert  and 
hazardous 
substances 
into 
migrating  from  FCMs 
food  may  endanger  human 
health  or  bring  about  an 
unacceptable  change  in  the 
composition or taste of food 

Secure  a  high 
level  of 
protection  of  human  health 
and  interests  of  consumer 
and  ensure  substances  do 
not  migrate  in  amounts  that 
present  a  risk  to  consumers 
or change the composition or 
taste of the food 

Basic  practices  for  manufacture 
of FCMs may be poor* 

Ensure  FCMs  are  manufactured 
to a high standard using GMP 

safety 
Procedures 
assessment  of  substances  not 
transparent or detailed enough * 

for 

Consumers may not be aware of 
the intended use of an FCM* 

Traceability  not  ensured  along 
the  supply  chain;  rules  in  Reg 
178/2002 do not apply to FCMs* 

is  not 

Enforceability  at  the  technical 
ensured 
level 
and 
provisions 
for  EURL-FCM  and 
NRLs did not exist* 

Technological  progress  is  rapid 
and  some  new  types  of  FCMs 
(AIM  packaging)  and  processes 
the 
(recycling) 
market or identified as relevant* 

introduced 

to 

transparency  of 

the 
Improve 
authorisation 
by 
specifying  the  various  phases  of 
the procedure 

process 

labelling 

inform 
Ensure 
consumers  on  the  correct  and 
safe use of FCMs 

to 

Ensure better traceability 

Provide more support to MSs and 
ensure  better  enforceability  of 
the rules  

Use  of  directives 
inconsistent 
and 
application of the rules* 

leads 

to 
delayed 

swift 

Ensure 
timely 
application  of  the  rules  in  all 
Member States 

and 

Free  movement  of  FCMs  on 
the  internal  market  may  be 
hindered  by  differences  that 
exist  between  national  laws, 
of 
creating 
unequal 
unfair 
competition  

conditions 

and 

Take 
into  account 
technological  developments 
the area of FCM 

important 
in 

Ensure the free movement of 
FCMs on the market 

legal  requirement 

General 
to 
manufacture  FCM  in  accordance 
with  GMP  so  that  they  do  not 
transfer  constituents  into  food 
that  could  endanger  human 
health 
the 
composition 
organoleptic 
qualities in an adverse way 

change 

or 

or 

Basic rules introduced on GMP 

can 

be 
Specific  measures 
for  certain  FCMs 
introduced 
including  an  assessment  and 
authorisation 
substances 
of 
before they can be used  

for 

EFSA  designated  as  competent 
body 
assessment. 
risk 
Application process for substance 
authorisations clearly set out 

Safeguard measures by MSs 

National  measures  by  MSs  in 
absence of EU-specific measures 

Rules on labelling of FCM 

Rules on traceability of FCM 

DoC  and  supporting  documents 
mandatory for specific rules 

Requirement for MSs to carry out 
controls and have sanctions 
96 

for 

requirement 

Establishment  of  EURL-FCM/NRL 
and 
test 
methods 
Special  rules  introduced  for  AIM 
recycling 
and 
packaging 
processes 
Powers  to  the  Commission  to 
adopt Regulations and Decisions 

Substances  do  not  migrate  from 
FCM  in  amounts  that  present  a 
risk  to  consumers  or  change  the 
composition or taste of the food 

FCMs  are  manufactured 
accordance with GMP 

in 

Safety  of  substances  used  to 
manufacture  FCMs  are  assured 
and  migration  does  not  occur 
into  food  at  levels  harmful  to 
consumers. 

Application process for substance 
authorisations  is  clear  and  easy 
for  businesses;  risk  assessment 
and  risk  management  decisions 
are transparent 

Immediate  risks  or  priorities  for 
individual MSs can be addressed 

FCMs  are 
allowing safe use by consumers 

labelled 

correctly 

FCMs can be traced at all stages 
up and down the supply chain in 
case of withdrawal or recall 

EURL-FCM  and  NRL  provide 
support for control labs; methods 
of analysis for controls available 

FCMs  effectively  controlled  and 
enforced on EU market 

New  technologies  for  FCM  are 
addressed and safe 

Rules apply without delay 

Prevention  or  reduction 
illnesses  associated 
in 
with 
to 
exposure 
harmful  substances  that 
can migrate from FCMs 

Effective  functioning  of 
the 
internal  market 
supporting businesses 

 
 
 
 
 
 
 
* New elements introduced in 2004 

  To  take  into  account  technological  developments  in  the  area  of  FCMs, 
Regulation  (EC)  1935/2004  introduced  an  updated  list  of  materials  for  which 
specific  measures  can  be  adopted,  as  well  as  specific  provisions  on  active  and 
intelligent  materials 
foreseen  as  new 
technological solutions in the field of food packaging production. 

recycling  processes, 

(AIM)  and 

  To ensure transparency of the safety assessment procedures of FCMs and to 
ensure  accountability  and  dependency  of  the  authorisation  processes,  the 
functions of risk manager and risk assessor were separated under the  regulation. 
EFSA was designated the competent body to undertake risk assessment on FCMs 
replacing  the  former  SCF.  The  regulation  established  specific  procedures  for 
substance  authorisation  and  specific  provisions  on  public  access  to  applications 
for  authorisation,  supplementary  information  from  applicants  and  opinions  from 
EFSA. 

  To  ensure  traceability  throughout  the  FCM  supply  chain,  a  requirement  for 
traceability  was  introduced  to  facilitate  self-control  for  businesses,  the  recall  of 
defective  products,  consumer  information  and  the  attribution  of  responsibility. 
Under  the  FCM  Regulation  FCMs  must  be  traceable  by  means  of  labelling, 
relevant documentation and adequate information provided to the supply chain. 

  To  ensure  that  the  rules  on  FCMs  are  enforced  and  sanctions  in  place,  the 
FCM Regulation introduced requirements for Member States to carry out official 
controls  on  FCMs  and  take  all  measures  necessary  to  ensure  that  sanctions  are 
implemented  and  are  effective,  proportionate  and  dissuasive.  The  JRC  was 
subsequently established as the EU Reference Laboratory (EURL-FCM) for FCM 
to assist Member States through their National Reference Laboratories (NRLs) in 
controlling FCMs and support high quality and uniformity of analytical results.  

  Council  Directive  89/109/EEC  had  already  introduced  an  obligation  for  FCMs 
governed by specific rules to require a declaration of compliance (DoC) to attest 
compliance  with  specific  EU  rules.  An  obligation  for  appropriate  supporting 
documentation  (SD)  to  be  made  available  to  Member  States  was  added  to 
complement the DoC and provide the detailed reasons for compliance of the FCM 
and matters such as testing results.   

  As regards the interests of consumers,  a legal requirement was also introduced 
to  mislead 

labelling,  advertising  and  presentation  of  FCMs 

prohibiting 
consumers. 

97