EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
on plastic materials and articles inte nded to come into contact with food 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
on plastic materials and articles inte nded to come into contact with food 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intended to come into  contact with food 
and repealing Directives  80/590/EEC and 89/109/EEC
1, and in particular Ar ticle 5(1) (a), (c), 
(d), (e), (f), (h), (i) and (j) thereof, 
After consulting the European Food Safety Authority, Whereas: (1) Regulation (EC) No 1935/2004 la ys down the general principles for eliminating the 
differences between the laws of the Member States as regards food contact materials. 
Article 5(1) of that Regulation provides for the adoption of specific measures for 
groups of materials and articles and desc ribes in detail the procedure for the 
authorisation of substances at EU level when a specific measure provides for a list of 
authorised substances. 
(2) This Regulation is a specific measure within  the meaning of Article  5(1) of Regulation 
(EC) No 1935/2004. This Regulation should es tablish the specific rules for plastic 
materials and articles to be applied for th eir safe use and repeal Commission Directive 
2002/72/EC of 6 August 2002 on plastic material s and articles intended to come into 
contact with foodstuffs
2. 
(3) Directive 2002/72/EC sets out basic rules for the manufactur e of plastic materials and 
articles. The Directive has been substantia lly amended 6 times. For reasons of clarity 
the text should be consolidated a nd redundant and obsolete parts removed. 
(4) In the past Directive 2002/72/EC and its am endments have been transposed into 
national legislation without any major adap tation. For transposition into national law 
usually a time period of 12 months is n ecessary. In case of amending the lists of 
monomers and additives in order to authorise new substances this transposition time 
                                                 
1 OJ L 338, 13.11.2004, p. 4. 
2 OJ L 220, 15.8.2002, p. 18.  
EN 3   EN leads to a retardation of the authorisation and thus slows down innovation. Therefore it 
seems appropriate to adopt rules on plastic  materials and articles in form of a 
Regulation directly applicab le in all Member States. 
(5) Directive 2002/72/EC applies to materials a nd articles purely made of plastics and to 
plastic gaskets in lids. In the past these were the main use of plastics on the market. 
However, in recent years, besides material s and articles purely made of plastics, 
plastics are also used in combination with  other materials in so called multi-material 
multi-layers. Rules on the use of vinyl chloride monomer laid down in Council 
Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the 
Member States relating to materials a nd articles which contain vinyl chloride 
monomer and are intended to co me into contact with foodstuffs3 already apply to all 
plastics. Therefore it seems appropriate to extend the scope of this Regulation to plastic layers in multi-material multi-layers. 
(6) Plastic materials and articles may be compos ed of different layers of plastics held 
together by adhesives. Plastic materials and articles may also be printed or coated with 
an organic or inorganic coating.  Printed or coated plastic ma terials and articles as well 
as those held together by adhesives should be within the scope of the Regulation. 
Adhesives, coatings and printing inks ar e not necessarily composed of the same 
substances as plastics. Re gulation (EC) No 1935/2004 fore sees that for adhesives, 
coatings and printing inks specific meas ures can be adopted. Therefore plastic 
materials and articles that ar e printed, coated or held t ogether by adhesives should be 
allowed to contain in the pr inting, coating or adhesive layer other substances than 
those authorised at EU level for plastics. T hose layers may be subject to other EU or 
national rules. 
(7) Plastics as well as ion exchange resins , rubbers and silicones are macromolecular 
substances obtained by polymerisation processes. Regulation (EC) No 1935/2004 
foresees that for ion exchange resins, rubbe rs and silicones specific measures can be 
adopted. As those materials are composed of  different substances than plastics and 
have different physico-chemical properties spec ific rules for them need to apply and it 
should be made clear that they are not within the scope of  this Regulation. 
(8) Plastics are made of monomers and other starting substances which are chemically 
reacted to a macromolecular structure, th e polymer, which forms the main structural 
component of the plastics. To the polymer  additives are added to achieve defined 
technological effects. The polymer as such is  an inert high molecular weight structure. 
As substances with a molecular weight a bove 1000 Da usually ca nnot be absorbed in 
the body the potential health risk from the pol ymer itself is minimal. Potential health 
risk may occur from non- or incomplete ly reacted monomers or other starting 
substances or from low molecular weight ad ditives which are transferred into food via 
migration from the plastic food contact mate rial. Therefore monome rs, other starting 
substances and additives should be risk assessed and authoris ed before their use in the 
manufacture of plastic materials and articles. 
(9) The risk assessment of a s ubstance to be performed by the European Food Safety 
Authority (hereinafter "the Authority") s hould cover the substa nce itself, relevant 
                                                
 
3 OJ L 44, 15.2.1978, p. 15.  
EN 4   EN impurities and foreseeable reac tion and degradation products in the intended use. The 
risk assessment should cover the poten tial migration under worst foreseeable 
conditions of use and the t oxicity. Based on the risk assessment the authorisation 
should if necessary set out sp ecifications for the substanc e and restrictions of use, 
quantitative restrictions or migration limits to ensure the safety of the final material or 
article. 
(10) No rules have yet been set out at EU level for the risk assessment and use of colorants 
in plastics. Therefore their use should rema in subject to national law. That situation 
should be reassessed at a later stage. 
(11) Solvents used in the manufacture of plastics to create a suitable reaction environment 
are expected to be removed in the manufact uring process as they are usually volatile. 
No rules have yet been set out at EU level for the risk assessment and use of solvents 
in the manufacture of plastics. Therefore th eir use should remain subject to national 
law. That situation should be reassessed at a later stage. 
(12) Plastics can also be made of synthetic or  natural occurring macromolecular structures 
which are chemically reacted with other starting substanc es to create a modified 
macromolecule. Synthetic macromolecules used are often intermediate structures which are not fully polymerised. Potential health risk may occur from the migration of non- or incompletely reacted other star ting substances used to modify the 
macromolecule or an incompletely reacted macromolecule. Therefore the other starting substances as well as the macromolecu les used in the manu facture of modified 
macromolecules should be risk assessed an d authorised before their use in the 
manufacture of plastic materials and articles. 
(13) Plastics can also be made by micro-organi sms that create macromolecular structures 
out of starting substances by fermentation proc esses. The macromolecule is then either 
released to a medium or extracted. Potentia l health risk may occur from the migration 
of non- or incompletely reacted starting s ubstances, intermediate s or by-products of 
the fermentation process. In this case th e final product should be risk assessed and 
authorised before its use in the manufact ure of plastic materials and articles. 
(14) Directive 2002/72/EC contains different lists for monomers or other starting 
substances and for additives authorised for the manufacture of plastic materials and articles. For monomers, other starting substa nces and additives the Union list is now 
complete, this means that only substances  authorised at EU level may be used. 
Therefore a separation of monomers or othe r starting substances and of additives in 
separate lists due to their authorisation st atus is no longer necessary. As certain 
substances can be used both as monomer or  other starting substa nces and as additive 
for reasons of clarity they should be publis hed in one list of authorised substances 
indicating the authorised function. 
(15) Polymers can not only be used as main stru ctural component of plastics but also as 
additives achieving defined tec hnological effects in the pl astic. If such a polymeric 
additive is identical to a polymer that can  form the main struct ural component of a 
plastic material the risk from polymeric add itive can be regarded as evaluated if the 
monomers have already been evaluated and authorised. In such a case it should not be 
necessary to authorise the polymeric additive but it could be used on the basis of the 
authorisation of its monomers and other starting substances. If such a polymeric  
EN 5   EN additive is not identical to a polymer that can form the main stru ctural component of a 
plastic material then the risk of the pol ymeric additive can not be regarded as 
evaluated by evaluation of the monomers. In  such a case the polymeric additive should 
be risk assessed as regards its low mo lecular weight fraction below 1000 Da and 
authorised before its use in the manufact ure of plastic materials and articles. 
(16) In the past no clear differentiation has b een made between additives that have a 
function in the final polymer and polymer production aids (PPA) that only exhibit a 
function in the manufacturing process and are not intended to be present in the final 
article. Some substances acting as PPA ha d already been included in the incomplete 
list of additives in the past. These PPA shoul d remain in the Union list of authorised 
substances. However, it should be made cl ear that the use of other PPA will remain 
possible, subject to national la w. That situation should be reassessed at a later stage. 
(17) The Union list contains substances authoris ed to be used in the manufacture of 
plastics. Substances such as  acids, alcohols and phenols can  also occur in form of 
salts. As the salts usually are transformed in  the stomach to acid, alcohol or phenol the 
use of salts with cations that have under gone a safety evaluation should in principle be 
authorised together with the acid, alcohol or  phenol. In certain cases, where the safety 
assessment indicates concerns on the use of the free acids, only the salts should be 
authorised by indicating in the list the name as '... acid(s), salts'. 
(18) Substances used in the manu facture of plastic material s or articles may contain 
impurities originating from their manufacturing or extraction process. These impurities are non-intentionally added t ogether with the substance in the manufacture of the 
plastic material (non-intentionally added substance – NIAS). As far as they are 
relevant for the risk assessment the ma in impurities of a substance should be 
considered and if necessary be included in  the specifications of a substance. However 
it is not possible to list and consider all im purities in the authoris ation. Therefore they 
may be present in the material or arti cle but not included in the Union list. 
(19) In the manufacture of polymers substances are used to initiate the polymerisation 
reaction such as catalysts and to control the polymerisation reaction such as chain transfer, chain extending or chain stop reag ents. These aids to pol ymerisation are used 
in minute amounts and are not in tended to remain in the fi nal polymer. Therefore they 
should at this point of time not be subject to  the authorisation pro cedure at EU level. 
Any potential health risk  in the final material or articl e arising from their use should be 
assessed by the manufacturer in accordance with  internationally recognized scientific 
principles on risk assessment. 
(20) During the manufacture and use of plas tic materials and articles reaction and 
degradation products can be formed. These reaction and degradation products are non-
intentionally present in the plastic material (NIAS). As far as they  are relevant for the 
risk assessment the main reaction and degrad ation products of the intended application 
of a substance should be considered and includ ed in the restrictions of the substance. 
However it is not possible to list and consider all reaction and degradation products in 
the authorisation. Therefore they  should not be listed as sing le entries in the Union list. 
Any potential health risk in the final material or article arising from reaction and 
degradation products should be assessed by  the manufacturer in accordance with 
internationally recognized scientific  principles on risk assessment.  
EN 6   EN (21) Prior to the establishment of the Union lis t of additives, other additives than those 
authorised at EU level could be used in the manufacture of plastics. For those 
additives which were permitted in the Member States, the time limit for the 
submission of data for their safety evaluati on by the Authority w ith a view to their 
inclusion in the Union list expired on 31 December 2006. Additives for which a valid application was submitted within this time lim it were listed in a provisional list. For 
certain additives on the provisi onal list a decision on their authorisation at EU level 
has not yet been taken. For those additives, it should be possible to continue to be used in accordance with national law until their evaluation is complete d and a decision is 
taken on their inclusi on in the Union list. 
(22) When an additive included in the provisional lis t is inserted in the Union list or when it 
is decided not to include it in the Union list , that additive should  be removed from the 
provisional list of additives. 
(23) New technologies engineer substances in particle size that exhibit chemical and 
physical properties that  significantly differ from those at  a larger scale, for example, 
nanoparticles. These different properties may lead to different toxicological properties 
and therefore these substances should be assessed on a case-by-case basis by the 
Authority as regards their risk until mo re information is known about such new 
technology. Therefore it should be  made clear that authoris ations which are based on 
the risk assessment of the conventional pa rticle size of a substance do not cover 
engineered nanoparticles. 
(24) Based on the risk assessment the authoris ation should if necessary set out specific 
migration limits to ensure the safety of the final material or article. If an additive that is authorised for the manufacture of plastic ma terials and articles is at the same time 
authorised as food additive or flavouring su bstance it should be ensured that the 
release of the substance does not cha nge the composition of the food in an 
unacceptable way. Therefore the release of such a dual use additive or flavouring 
should not exhibit a technological functi on on the food unless such a function is 
intended and the food contact material comp lies with the requireme nts on active food 
contact materials set out in Regula tion (EC) No 1935/2004 and Commission 
Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and 
articles intended to come into contact with food
4. The requirements of Regulations 
(EC) No 1333/2008 of the European Parlia ment and of the Council of 16 December 
2008 on food additives5 or (EC) No 1334/2008 of the Eur opean Parliament and of the 
Council of 16 December 2008 on flavourings  and certain food ingredients with 
flavouring properties for use in and on f oods and amending Council Regulation (EEC) 
No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 
2000/13/EC6 should be respected where applicable. 
(25) According to point (b) of Article 3(1) of  Regulation (EC) No 1935/2004 the release of 
substances from food contact material s and articles shoul d not bring about 
unacceptable changes in the compositio n of the food. According to good 
manufacturing practice it is f easible to manufacture plastic materials in such a way that 
                                                 
4 OJ L 135, 30.5.2009, p. 3. 
5 OJ L 354, 31.12.2008, p. 16. 
6 OJ L 354, 31.12.2008, p. 34.  
EN 7   EN they are not releasing more than  10 mg of substances per 1 dm2 of surface area of the 
plastic material. If the risk assessment of an individual substan ce is not indicating a 
lower level, this level should be set as a generic limit for the inertness of a plastic 
material, the overall migration limit. In or der to achieve comparable results in the 
verification of compliance with the overa ll migration limit, testing should be 
performed under standardised test conditi ons including testing tim e, temperature and 
test medium (food simulant) representing wo rst foreseeable conditions of use of the 
plastic material or article. 
(26) The overall migration limit of 10 mg per 1 dm2 results for a cubic packaging 
containing 1kg of food to a migration of  60 mg per kg food. For small packaging 
where the surface to volume ratio is higher th e resulting migration into food is higher. 
For infants and small children which have a higher consumption of food per kilogram 
bodyweight than adults and do not  yet have a diversified nu trition, special provisions 
should be set in order to limit the intake of substances migrating from food contact 
materials. In order to allow also for sma ll volume packaging the same protection as for 
high volume packaging, the overall migration li mit for food contact materials that are 
dedicated for packaging foods for infants and small children should be linked to the limit in food and not to the su rface area of the packaging.  
(27) In recent years plastic food contact materials are being developed that do not only 
consist of one plastic but combine up to 15 di fferent plastic layers to attain optimum 
functionality and protection of the food, wh ile reducing packaging waste. In such a 
plastic multi-layer material or article, la yers may be separated from the food by a 
functional barrier. This barrier is a layer within food contact materials or articles 
preventing the migration of substances from  behind that barrier into the food. Behind a 
functional barrier, non-authorised substances may be used, provided they fulfil certain 
criteria and their migration remains below a given detection limit. Taking into account 
foods for infants and other particularly su sceptible persons, as well as the large 
analytical tolerance of the migration analysis, a maximum level of 0,01 mg/kg in food 
should be established for the migration of a non-authorised substance through a 
functional barrier. Substances that ar e mutagenic, carcinogenic or toxic to 
reproduction should not be used in food contac t materials or articl es without previous 
authorisation and should ther efore not be covered by the functional barrier concept. 
New technologies that engineer substances in  particle size that exhibit chemical and 
physical properties that  significantly differ from those at  a larger scale, for example, 
nanoparticles, should be assessed on a case -by-case basis as rega rds their risk until 
more information is known about such ne w technology. Therefore, they should not be 
covered by the functiona l barrier concept. 
(28) In recent years food contact materials and arti cles are being developed that consist of a 
combination of several materials to achieve  optimum functionality  and protection of 
the food while reducing packaging waste. In  these multi-material multi-layer materials 
and articles plastic layers should comply with the same compositional requirements as 
plastic layers which are not combined with other materials. For plastic layers in a 
multi-material multi-layer which are separated from the food by a functional barrier the functional barrier concept should apply. As  other materials are combined with the 
plastic layers and for these other materials specific measures are not yet adopted at EU 
level it is not yet possible to set out requirements for the final multi-material multi-layer materials and articles. Therefore specific migration limits and the overall 
migration limit should not be applicable ex cept for vinyl chloride monomer for which  
EN 8   EN such a restriction is already in place. In th e absence of a specific measure at EU level 
covering the whole multi-material multi-layer material or article Member States may maintain or adopt national provisions for these materials and articles provided they 
comply with the rules of the Treaty. 
(29) Article 16(1) of Regulation (EC) No 1935/ 2004 provides that materials and articles 
covered by specific measures be accompan ied by a written declaration of compliance 
stating that they comply w ith the rules applicable to them. To strengthen the co-
ordination and responsibility of  the suppliers at each stag e of manufacture, including 
that of the starting substances, the re sponsible persons should document the 
compliance with the relevant rules in a declaration of compliance which is made available to their customers. 
(30) Coatings, printing inks and adhesives are not  yet covered by a specific EU legislation 
and therefore not subject to the requirement of a declarat ion of compliance. However, 
for coatings, printing inks and adhesives to be used in plastic materials and articles 
adequate information should be provided to th e manufacturer of the final plastic article 
that would enable him to ensure compliance for substances for which migration limits 
have been established in this Regulation. 
(31) Article 17(1) of Regulation (EC) No 178/2002 of the European Parliament and of the 
Council of 28 January 2002 layi ng down the general princi ples and requirements of 
food law, establishing th e European Food Safety Au thority and laying down 
procedures in matters of food safety
7 requires the food business operator to verify that 
foods are compliant with the rules applicable  to them. To this end and subject to the 
requirement of confidentiality, food business operators should be given access to the 
relevant information to enable them to ensure that the migration from the materials and articles to food complies with  the specifications and rest rictions laid down in food 
legislation. 
(32) At each stage of manufacture, supporting documentation, substantiating the 
declaration of compliance, should be kept available for the enforcement authorities. 
Such demonstration of compliance may be based on migration tes ting. As migration 
testing is complex, costly and time consum ing it should be admissible that compliance 
can be demonstrated also by calculations , including modelling, ot her analysis, and 
scientific evidence or reasoning if these rende r results which are at least as severe as 
the migration testing. Test results should be regarded as valid as long as formulations 
and processing conditions remain constant as part of a quality assurance system. 
(33) When testing articles not yet in  contact with food, for certain articles, such as films or 
lids, it is often not feasible to determine the surface area that is in contact with a 
defined volume of food. Fo r these articles specific ru les should be set out for 
verification of compliance. 
(34) The setting of migration limits takes into  account a conventional assumption that 1kg 
of food is consumed daily by a person of 60 kg bodyweight and that the food is 
packaged in a cubic container of 6 dm
2 surface area releasing the substance.. For very 
small and very large containers the real su rface area to volume of packaged food is 
                                                 
7 OJ L 31, 1.2.2002, p. 1.  
EN 9   EN varying a lot from the conventional assump tion. Therefore, their surface area should 
be normalised before comparing testing results with migration limits. These rules should be reviewed when new data on food packaging uses become available. 
(35) The specific migration limit is a maximum permitted amount of a substance in food. 
This limit should ensure that the food contact material does not pose a risk to health. It 
should be ensured by the manufacturer that materials and articles  not yet in contact 
with food will respect these limits when brought into contact  with food under the 
worst foreseeable contact conditions. Theref ore compliance of materials and articles 
not yet in contact with food should be assesse d and the rules for this testing should be 
set out. 
(36) Food is a complex matrix and therefore the an alysis of migrating substances in food 
may pose analytical difficulties. Therefore te st media should be assigned that simulate 
the transfer of substances from the plasti c material into food. They should represent 
the major physico-chemical properties exhi bited by food. When using food simulants 
standard testing time and temperature shou ld reproduce, as fa r as possible, the 
migration which may occur from the article into the food. 
(37) For determining the appropriate food simu lant for certain foods the chemical 
composition and the physical properties of the food should be taken into account. Research results are available for certain  representative foods comparing migration 
into food with migration in to food simulants. On the basis of the results, food 
simulants should be assigned. In particular, fo r fat containing foods the result obtained 
with food simulant may in cer tain cases significantly overe stimate migration into food. 
In these cases it should be foreseen that th e result in food simulant is corrected by a 
reduction factor. 
(38) The exposure to substances migrating from  food contact materi als was based on the 
conventional assumption that a person c onsumes daily 1 kg of food. However, a 
person ingests at most 200 g of fat on a daily basis. For lipophilic s ubstances that only 
migrate into fat this should be taken into  consideration. Therefor e a correction of the 
specific migration by a correct ion factor applicable to  lipophilic substances in 
accordance with the opinion of the Scientific Committee on Food (SCF)
8 and the 
opinion of the Authority9 should be foreseen. 
(39) Official control should establish testing strategies which allow the enforcement 
authorities to perform controls efficientl y making best use of available resources. 
Therefore it should be admissible to use screening methods for checking compliance 
under certain conditions. Non-comp liance of a material or article should be confirmed 
by a verification method. 
(40) Basic rules on migration testing should be set out in this Regulation. As migration 
testing is a very complex issue, thes e basic rules can, however, not cover all 
                                                 
8 SCF opinion of 4 December 2002 on the introduction of a Fat (Cons umption) Reduction Factor (FRF) 
in the estimation of the exposure to a migrant from food contact materials. 
 http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf 
9 Opinion of the Scientific Panel on Food Additiv es, Flavourings, Processing Aids and Materials in 
Contact with Food (AFC) on a request from the Commission related to the introduction of a Fat 
(consumption) Reduction Factor for infants and children, The EFSA Journal (2004) 103, 1-8.  
EN 10   EN foreseeable cases and details necessary fo r performing the testing. Therefore a EU 
guidance document should be established, d ealing with more detailed aspects of the 
implementation of the basic migration testing rules. 
(41) The updated rules on food simulants and migra tion testing provided by this Regulation 
will supersede those in Directive 78/142/EEC and the Annex to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rule s necessary for testing 
migration of the constituents of plastic mate rials and articles intended to come into 
contact with foodstuffs
10. 
(42) Substances present in the plas tic but not listed in Annex I to this Regulation have not 
necessarily been risk assesse d as they had not been subject to an authorisation 
procedure. Compliance with Article 3 of Regulation (EC) No 1935/2004 for these 
substances should be assessed by the releva nt business operator in accordance with 
internationally recognised scie ntific principles taking into  account exposure from food 
contact materials and other sources. 
(43) Recently additional monomers, other starting substances and additives have received a 
favourable scientific evalua tion by the Authority and should now be added to the 
Union list. 
(44) As new substances are added to the Union list the Regulation should apply as soon as 
possible to allow for manufacturers to ad apt to technical progress and allow for 
innovation. 
(45) Certain migration testing rule s should be updated in view of  new scientific knowledge. 
Enforcement authorities and industry need to  adapt their current testing regime to 
these updated rules. To allow for this ad aptation it seems appropr iate that the updated 
rules only apply 2 years after the adoption of the Regulation. 
(46) Business operators are currently basing thei r declaration of compliance on supporting 
documentation following the requirement s set out in Directive 2002/72/EC. 
Declaration of compliance n eed, in principle, only to be updated when substantial 
changes in the production bring about changes in the migration or when new scientific 
data are available. In order to limit the burden to business operators, materials which have been lawfully placed on the market ba sed on the requirements set out in Directive 
2002/72/EC should be able to be placed on the market with  a declaration of 
compliance based on supporting documentation in accordance with Directive 2002/72/EC until 5 years after the adoption of the Regulation. 
(47) Analytical methods for tes ting migration and residual c ontent of vinyl chloride 
monomer as described in Commission Di rectives 80/766/EEC of 8 July 1980 laying 
down the Community method of analysis for th e official control of  the vinyl chloride 
monomer level in materials and articles whic h are intended to come into contact with 
foodstuffs
11 and 81/432/EEC of 29 April 1981 layi ng down the Community method of 
analysis for the official control of vinyl ch loride released by materials and articles into 
foodstuffs12 are outdated. Analytical methods shoul d comply with the criteria set out 
                                                 
10 OJ L 297, 23.10.1982, p. 26. 
11 OJ L 213, 16.8.1980, p. 42. 
12 OJ L 167, 24.6.1981, p. 6.  
EN 11   EN in Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the 
Council on official controls performed to en sure the verification of compliance with 
feed and food law, animal hea lth and animal welfare rules13. Therefore Directives 
80/766/EEC and 81/432/EEC s hould be repealed.  
(48) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health 
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
GENERAL PROVISIONS 
Article 1 
Subject matter 
1. This Regulation is a specific measure within the meaning of Article 5 of Regulation 
(EC) No 1935/2004. 
2. This Regulation establishes specific re quirements for the manufacture and marketing 
of plastic materials and articles: 
(a) intended to come into contact with food, or  (b) already in contact with food or (c) which can reasonably be expected  to come into contact with food. 
Article 2 
Scope 
1. This Regulation shall apply to material s and articles which are placed on the EU 
market and fall under the following categories:  
(a) materials and articles and parts ther eof consisting exclus ively of plastics; 
(b) plastic multi-layer materials and articl es held together by adhesives or by other 
means; 
(c) materials and articles referred to in points a) or b) that are printed and/or 
covered by a coating; 
(d) plastic layers or plastic coatings, fo rming gaskets in caps and closures, that 
together with those caps and closures co mpose a set of two or more layers of 
different types of materials; 
                                                
 
13 OJ L 165, 30.4.2004, p. 1.  
EN 12   EN (e) plastic layers in multi-material multi-layer materials and articles. 
2. This Regulation shall not apply to the fo llowing materials and articles which are 
placed on the EU market and are intended to  be covered by other specific measures: 
(a) ion exchange resins; (b) rubber; (c) silicones. 
3. This Regulation shall be without prej udice to the EU or national provisions 
applicable to printing inks , adhesives or coatings. 
Article 3 
Definitions 
For the purpose of this Regulation, the following definitions shall apply: 
(1) "plastic materials and articles" means: 
(a) materials and articles referred to in po ints (a), (b) and (c) of Article 2(1), and 
(b) plastic layers referred to in points (d) and (e) of Article 2(1); 
(2) "plastic" means polymer to which additives or other substances may have been 
added, which is capable of functioning as a main struct ural component of final 
materials and articles; 
(3) "polymer" means any macromolecular substance obtained by:  
(a) a polymerisation process such as polyaddition or polycondensation, or by any 
other similar process of monomers and other starting substances; or 
(b) chemical modification of natural or synthetic macromolecules; or  
(c) microbial fermentation; 
(4) "plastic multi-layer" means a material or article composed of two or more layers of 
plastic; 
(5) "multi-material multi-layer" means a material or article composed of two or more 
layers of different types of  materials, at least one of them a plastic layer; 
(6) "monomer or other star ting substance" means: 
(a) a substance undergoing any type of polymerisation process to manufacture 
polymers; or 
(b) a natural or synthetic macromolecular substance used in the manufacture of 
modified macromolecules; or  
EN 13   EN (c) a substance used to modify existi ng natural or synthetic macromolecules; 
(7) "additive" means a substance which is inte ntionally added to plastics to achieve a 
physical or chemical effect du ring processing of the plastic or in the final material or 
article; it is intended to be presen t in the final material or article; 
(8) "polymer production aid" means any substa nce used to provide a suitable medium for 
polymer or plastic manufacturing; it may be  present but is neith er intended to be 
present in the final materials or articles nor has a physical or chemical effect in the 
final material or article; 
(9) "non-intentionally added substance" means an impurity in the substances used or a 
reaction intermediate formed during the production process or  a decomposition or 
reaction product; 
(10) "aid to polymerisation"  means a substance which init iates polymerisation and/or 
controls the formation of th e macromolecular structure; 
(11) "overall migration lim it" (OML) means the maximum permitted amount of non 
volatile substances released from a mate rial or article into food simulants; 
(12) "food simulant" means a test medium imitating food; in its behaviour the food 
simulant mimics migration from food contact materials; 
(13) "specific migration limit" (SML) mean s the maximum permitted amount of a given 
substance released from a material or article into food or  food simulants; 
(14) "total specific migration limit" (S ML(T)) means the maximum permitted sum of 
particular substances released in food or food simulants expressed as total of moiety 
of the substances indicated; 
(15) "functional barrier" means a barrier consisting of one or more layers of any type of 
material which ensures that the final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with the provisions  of this Regulation; 
(16) "non-fatty food" means a food for whic h in migration testing only food simulants 
other than food simulants D1 or D2 are la id down in Table 2 of Annex V of this 
Regulation;  
(17) "restriction" means limitation of use of  a substance or migration limit or limit of 
content of the substance in the material or article; 
(18) "specification" means co mposition of a substance, purit y criteria for a substance, 
physico-chemical characteristics of a substance, details concerning the 
manufacturing process of a substance or  further information concerning the 
expression of migration limits.  
EN 14   EN Article 4 
Placing on the market of plastic materials and articles 
Plastic materials and articles may only be placed on the market if they: 
(a) comply with the relevant requirements set out in Article 3 of Regulation (EC) 
No 1935/2004 under intended and foreseeable use; and 
(b) comply with the labelling requirements  set out in Article 15 of Regulation (EC) 
No 1935/2004; and 
(c) comply with the traceability requirements set out in Article 17 of Regulation (EC) No 
1935/2004; and 
(d) are manufactured according to good manufact uring practice as set out in Commission 
Regulation (EC) No 2023/200614; and 
(e) comply with the compositional and declarat ion requirements set out in Chapters II, III 
and IV of this Regulation. 
CHAPTER II 
COMPOSITIONAL REQUIREMENTS 
SECTION 1 
AUTHORISED SUBSTANCES  
Article 5 
Union list of authorised substances 
1. Only the substances included in the Union list of authoris ed substances (hereinafter 
referred to as 'the Union list') set out in Annex I may be intentionally used in the 
manufacture of plastic layers in  plastic materials and articles. 
2. The Union list shall contain: 
(a) monomers or other starting substances; 
(b) additives excluding colorants; 
(c) polymer production ai ds excluding solvents; 
(d) macromolecules obtained from microbial fermentation. 
3. The Union list may be amended in accordan ce with the procedure established by 
Articles 8 to 12 of Regulation (EC) No 1935/2004. 
                                                 
14 OJ L 384, 29.12.2006, p. 75.   
EN 15   EN Article 6 
Derogations for substances not  included in the Union list 
1. By way of derogation from Article 5, subs tances other than those included in the 
Union list may be used as polymer production aids in the manufacture of plastic layers in plastic materials and ar ticles subject to national law. 
2. By way of derogation from Article 5, colo rants and solvents may be used in the 
manufacture of plastic layers in plastic materials and articl es subject to national law. 
3. The following substances not included in th e Union list are author ised subject to the 
rules set out in Articles 8, 9, 10, 11 and 12:  
(a) salts (including double salts and acid sa lts) of aluminium, ammonium, barium, 
calcium, cobalt, copper, iron, lithium,  magnesium, manganese, potassium, 
sodium, and zinc of authorised  acids, phenols or alcohols; 
(b) mixtures obtained by mixing authorised substances without a chemical reaction 
of the components; 
(c) when used as additives, natural or  synthetic polymeric substances of a 
molecular weight of at least 1000 Da , except macromolecules obtained from 
microbial fermentation, complying with th e requirements of this Regulation, if 
they are capable of functioning as the main structural component of final 
materials or articles; 
(d) when used as monomer or other starti ng substance, pre-poly mers and natural or 
synthetic macromolecular substances, as well as their mixtures, except macromolecules obtained from microbial  fermentation, if the monomers or 
starting substances required to synthesise  them are included in the Union list. 
4. The following substances not included in the Union list may be present in the plastic 
layers of plastic ma terials or articles: 
(a) non-intentionally added substances; 
(b) aids to polymerisation. 
5. By derogation from Article 5, additives not  included in the Union list may continue 
to be used subject to nati onal law after 1 January 2010 until  a decision is taken to 
include or not to include them in the Union list provided they are included in the provisional list refe rred to in Article 7. 
Article 7 
Establishment and management of the provisional list  
1. The provisional list of a dditives that are under evalua tion by the European Food 
Safety Authority (hereinafter referred to as  "the Authority") that  was made public by 
the Commission in 2008 shall be regularly updated.  
2. An additive shall be removed from the provisional list:  
EN 16   EN (a) when it is included in the Un ion list set out in Annex I; or 
(b) when a decision is taken by the Commission not to include it in the Union list; 
or 
(c) if during the examination of the data , the Authority calls  for supplementary 
information and that information is  not submitted within the time limits 
specified by the Authority. 
SECTION 2 
GENERAL REQUIREMENTS , RESTRICTIONS AND SPECIFICATIONS  
Article 8 
General requirement on substances  
Substances used in the manufactur e of plastic layers in plastic materials and articles shall be 
of a technical quality and a purity suitable for the intended and foreseeable use of the 
materials or articles. The composition shall be  known to the manufactur er of the substance 
and made available to the competent authorities on request. 
Article 9 
Specific requirements on substances  
1. Substances used in the manufacture of plas tic layers in plastic materials and articles 
shall be subject to the followi ng restrictions and specifications: 
(a) the specific migration limit set out in Article 11; (b) the overall migration limit set out in Article 12; (c) the restrictions and specifications set out  in column 10 of Table 1 of point 1 of 
Annex I; 
(d) the detailed specifications se t out in point 4 of Annex I. 
2. Substances in nanoform shall only be used  if explicitly authorised and mentioned in 
the specifications in Annex I. 
Article 10 
General restrictions on plastic materials and articles 
General restrictions related to plastic materi als and articles are laid down in Annex II.  
EN 17   EN Article 11 
Specific migration limits 
1. Plastic materials and articles shall not transfer their consti tuents to foods in quantities 
exceeding the specific migration limits (SML ) set out in Annex I. Those specific 
migration limits (SML) are expressed in mg of substance per kg of food (mg/kg). 
2. For substances for which no specific mi gration limit or other restrictions are 
provided in Annex I, a gene ric specific migration lim it of 60 mg/kg shall apply. 
3. By derogation from paragraphs 1 and 2, addi tives which are also authorised as food 
additives by Regulation (EC) No 1333/2008 or  as flavourings by Regulation (EC) No 
1334/2008 shall not migrate into foods in quant ities having a techni cal effect in the 
final foods and shall not: 
(a) exceed the restrictions provided fo r in Regulation (EC) No 1333/2008 or in 
Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for 
which their use is authoris ed as food additive or flavouring substances; or 
(b) exceed the restrictions set out in Anne x I to this Regulation in foods for which 
their use is not authorised as food additive or flavouring substances. 
Article 12 
Overall migration limit  
1. Plastic materials and articles  shall not transfer their constituents to food simulants in 
quantities exceeding 10 milligrams of total constituents released per dm2 of food 
contact surface (mg/dm2). 
2. By derogation from paragraph 1, plastic ma terials and articles intended to be brought 
into contact with food intended for infants and young childre n, as defined by 
Commission Directives 2006/141/EC15 and 2006/125/EC16, shall not transfer their 
constituents to food simulants in quanti ties exceeding 60 milligrams of total of 
constituents released per kg of food simulant. 
CHAPTER III 
SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND 
ARTICLES 
Article 13 
Plastic multi-layer materials and articles 
1. In a plastic multi-layer material or articl e, the composition of each plastic layer shall 
comply with this Regulation. 
                                                 
15 OJ L 401, 30.12.2006, p. 1. 
16 OJ L 339, 6.12.2006, p. 16.  
EN 18   EN 2. By derogation from paragraph 1, a plastic la yer which is not in direct contact with 
food and is separated from the f ood by a functional barrier, may: 
(a) not comply with the restrictions and specifications set out in this Regulation 
except for vinyl chloride monomer as provided in Annex I; and/or 
(b) be manufactured with substances not listed in the Union list or in the 
provisional list.  
3. The migration of the substances under poi nt (b) of paragraph 2 into food or food 
simulant shall not be detectable measured with statistical cert ainty by a method of 
analysis set out in Article 11 of Re gulation (EC) No 882/2004 with a limit of 
detection of 0,01mg/kg. That limit shall al ways be expressed as concentration in 
foods or food simulants. That limit shall apply to a group of compounds, if they are structurally and toxi cologically related, in  particular isomers or compounds with the 
same relevant functional group, and sha ll include possible set-off transfer. 
4. The substances not listed in the Union lis t or provisional list referred to in point (b) 
of paragraph 2 shall not belong to either of the following categories: 
(a) substances classified as “mutageni c”, “carcinogenic” or “toxic to reproduction” 
in accordance with the crite ria set out in sections 3.5, 3.6. and 3.7 of Annex I to 
Regulation (EC) No 1272/2008 of the Eu ropean Parliament and the Council
17; 
(b) substances in nanoform. 
5. The final plastic multi-layer material or  article shall comply with the specific 
migration limits set out in Article 11 and the overall migration limit set out in 
Article 12 of this Regulation. 
Article 14 
Multi-material multi-la yer materials and articles 
1. In a multi-material multi-layer material or article, the composition of each plastic 
layer shall comply with this Regulation. 
2. By derogation from paragraph 1, in a multi-material multi-layer material or article a 
plastic layer which is not in direct contact  with food and is separated from the food 
by a functional barrier, may be manufactured with substances not listed in the Union 
list or the provisional list.  
3. The substances not listed in the Uni on list or provisional li st referred to in 
paragraph 2 shall not belong to ei ther of the following categories: 
(a) substances classified as “mutageni c”, “carcinogenic” or “toxic to reproduction” 
in accordance with the crite ria set out in sections 3.5, 3.6. and 3.7 of Annex I to 
Regulation (EC) No 1272/2008; 
                                                 
17 OJ L 353, 31.12.2008, p. 1.  
EN 19   EN (b) substances in nanoform. 
4. By derogation from paragraph 1, Articles  11 and 12 of this Regulation do not apply 
to plastic layers in multi-material multi-layer materials and articles.  
5. The plastic layers in a multi-material multi-layer material or article shall always 
comply with the restrictions for vinyl chlo ride monomer laid down in Annex I to this 
Regulation.  
6. In a multi-material multi-layer material or article, specific and overall migration 
limits for plastic layers and for the final ma terial or article may be established by 
national law. 
CHAPTER IV 
DECLARATION OF COMPLIANCE  AND DOCUMENTATION  
Article 15 
Declaration of compliance 
1. At the marketing stages other than at the retail stage, a written declaration in 
accordance with Article 16 of Regulation (EC) No 1935/2004 shall be available for 
plastic materials and articles, products  from intermediate stages of their 
manufacturing as well as for the substances  intended for the manufacturing of those 
materials and articles.  
2. The written declaration referred to in paragraph 1 shall be issued by the business 
operator and shall contain the inform ation laid down in Annex IV.  
3. The written declaration shall permit an easy identification of the materials, articles or 
products from intermediate stages of manuf acture or substances for which it is 
issued. It shall be renewed when substantial changes in the composition or production occur that bring about changes in  the migration from the materials or 
articles or when new scientific data becomes available. 
Article 16 
Supporting documents 
1. Appropriate documentation to demonstrate that the materials and articles, 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 this Regulation shall be made available by the business operator to the national 
competent authorities on request. 
2. That documentation shall contain the conditi ons and results of te sting, calculations, 
including modelling, other analysis, and evidence on the safety or reasoning 
demonstrating compliance. Rules for experi mental demonstration of compliance are 
set out in Chapter V.  
EN 20   EN CHAPTER V 
COMPLIANCE 
Article 17 
Expression of migrat ion test results 
1. To check the compliance, the specific migr ation values shall be expressed in mg/kg 
applying the real surface to volume ratio in actual or foreseen use. 
2. By derogation from paragraph 1 for: 
(a) containers and other articles, contai ning or intended to contain, less than 
500 millilitres or grams or more than 10 litres, 
(b) materials and articles for which, due to their form it is impracticable to estimate 
the relationship between the surface area of such materials or articles and the 
quantity of food in contact therewith, 
(c) sheets and films that are not yet in contact with food, 
(d) sheets and films containing less than 500 millilitres or grams or more than 
10 litres, 
the value of migration shall be expressed in mg/kg applying a surface to volume ratio 
of 6 dm2 per kg of food . 
This paragraph does not apply to plastic ma terials and articles intended to be brought 
into contact with or alrea dy in contact with food for infants and young children, as 
defined by Directives 2006/141/EC and 2006/125/EC. 
3. By derogation from paragraph 1, for caps,  gaskets, stoppers and similar sealing 
articles the specific migration value shall be expressed in: 
(a) mg/kg using the actual content of the container for which the closure is 
intended or in mg/dm² applying the tota l contact surface of sealing article and 
sealed container if the intended use of the article is known, while taking into 
account the provisions of paragraph 2; 
(b) mg/article if the intended use of the article is unknown. 
4. For caps, gaskets, stoppers and similar s ealing articles the ove rall migration value 
shall be expressed in:  
(a) mg/dm² applying the total contact su rface of sealing article and sealed 
container if the intended us e of the article is known; 
(b) mg/article if the intended use of the article is unknown.  
EN 21   EN Article 18 
Rules for assessing compliance with migration limits 
1. For materials and articles already in contact with f ood verification of compliance 
with specific migration limits shall be carri ed out in accordance with the rules set out 
in Chapter 1 of Annex V. 
2. For materials and articles not yet in contact with food veri fication of compliance with 
specific migration limits shall be carried out  in food or in food simulants set out in 
Annex III in accordance with th e rules set out in Chapter 2, Section 2.1 of Annex V. 
3. For materials and articles not yet in cont act with food screeni ng of compliance with 
the specific migration limit can be perf ormed applying screening approaches in 
accordance with the rules set out in Chapter 2, Section 2.2 of Annex V. If a material 
or article fails to comply with the migr ation limits in the screening approach a 
conclusion of non-compliance has to be c onfirmed by verification of compliance in 
accordance with paragraph 2. 
4. For materials and articles not yet in contact with food veri fication of compliance with 
the overall migration limit shall be carried out in food simulants A, B, C, D1 and D2 
as set out in Annex III in accordance with th e rules set out in Chapter 3, Section 3.1 
of Annex V. 
5. For materials and articles not yet in cont act with food screeni ng of compliance with 
the overall migration limit can be perfor med applying screen ing approaches in 
accordance with the rules set out in Chapter 3, Section 3.4 of Annex V. If a material 
or article fails to comply with the mi gration limit in the screening approach a 
conclusion of non-compliance has to be c onfirmed by verification of compliance in 
accordance with paragraph 4. 
6. The results of specific migration testing obt ained in food shall prevail over the results 
obtained in food simulant. The results of specific migration testing obtained in food 
simulant shall prevail over the resu lts obtained by screening approaches. 
7. Before comparing specific and overall migration test results with the migration limits 
the correction factors in Chapter 4 of Anne x V shall be applied in accordance with 
the rules set out therein. 
Article 19 
Assessment of substances not included in the Union list 
Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances referred to in 
Articles 6(1), 6(2), 6(4), 6(5)  and 14(2) of this Regulatio n which are not covered by an 
inclusion in Annex I to this Regulation shall be assessed in accordance with internationally 
recognized scientific principles on risk assessment.  
EN 22   EN CHAPTER VI 
FINAL PROVISIONS 
Article 20 
Amendments of EU acts 
The Annex to Council Directive 85/572/EEC18 is replaced by the following: 
"The food simulants to be used for testing migr ation of constituents of plastic materials and 
articles intended to come into contact with a single food or sp ecific groups of foods are set out 
in point 3 of Annex III to Commission Regulation (EU) No [ indicate number of this 
Regulation ]." 
Article 21 
Repeal of EU acts 
Directives 80/766/EEC, 81/432/EEC, and 2002/72/EC are hereby repealed with effect from 1 
May 2011. 
References to the repealed Directives shall be construed as references to this Regulation and 
shall be read in accordance with the correlation tables in Annex VI. 
Article 22 
Transitional provisions  
1. Until 31 December 2012 the supporting document s referred to in Article 16 shall be 
based on the basic rules for overall and specific migration testing set out in the Annex to Directive 82/711/EEC. 
2. As from 1 January 2013 the supporting documents referred to in Article 16 for 
materials, articles and subs tances placed on the mark et until 31 December 2015, may 
be based on: 
(a) the rules for migration testing set out  in Article 18 of this Regulation, or 
(b) the basic rules for overall and specific migration testing set out in the Annex to 
Directive 82/711/EEC. 
3. As from 1 January 2016, the supporting docum ents referred to in  Article 16 shall be 
based on the rules for migration testing se t out in Article 18, without prejudice to 
paragraph 2 of this Article. 
4. Until 31 December 2015 additives used in glass fibre sizing for glass fibre reinforced 
plastics which are not listed in Annex I have to comply with the risk assessment 
provisions set out in Article 19. 
                                                
 
18 OJ L 372, 31.12.1985, p. 14.  
EN 23   EN 5. Materials and articles that have been la wfully placed on the market before 1 May 
2011 may be placed on the market until 31 December 2012. 
Article 23 
Entry into force and application 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union. 
It shall apply from 1 May 2011. The provision of Article 5 as regards the use of additives, others than plasticizers, shall apply 
for plastic layers or plastic coatings in caps a nd closures referred to in point (d) of Article 
2(1), as from 31 December 2015. 
The provision of Article 5 as regards the use of additives used in glass fibre sizing for glass 
fibre reinforced plastics, sha ll apply from 31 December 2015. 
The provisions of Articles 18(2), 18(4) and 20 shall apply from 31 December 2012. 
This Regulation shall be binding in its entirety a nd directly applicable in the Member States in 
accordance with the Treaties. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 24   EN ANNEX I  
 
Substances  
1. Union list of authorised monomers, ot her starting substances, macromolecules 
obtained from microbial fermentation, additives and polymer production aids 
Table 1 contains the following information: Column 1 (FCM Substance No): the unique identification number of the substance  
Column 2 (Ref. No): the EEC packag ing material reference number  
Column 3 (CAS No): the Chemical Ab stracts Service (CAS) registry number 
Column 4 (Substance Name): the chemical name  Column 5 (Use as additive or polymer pr oduction aid (PPA) (yes/no)): an indication 
if the substance is authorised to be used as additive or polyme r production aid (yes) 
or if the substance is not authorised to be  used as additive or  polymer production aid 
(no). If the substance is onl y authorised as PPA it is indicated (yes) and in the 
specifications the use is restricted to PPA. 
Column 6 (Use as monomer or other star ting substance or macromolecule obtained 
from microbial fermentation (yes/no)): an i ndication if the substan ce is authorised to 
be used as monomer or ot her starting substance or m acromolecule obtained from 
microbial fermentation (yes) or if the subs tance is not authorised to be used as 
monomer or other starting substance or macromolecule  obtained from microbial 
fermentation (no). If the substance is au thorised as macromolecule obtained from 
microbial fermentation it is indicated (yes) and in the specifications it is indicated 
that the substance is a macromolecule  obtained from microbial fermentation. 
Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration 
results can be corrected by the Fat Consum ption Reduction Factor (FRF) (yes) or if 
they cannot be correct ed by the FRF (no). 
Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. 
It is expressed in mg substance per kg food. It is indicated ND if the substance shall 
not migrate in detectable quantities.  
Column 9 (SML(T) [mg/kg] (group restrict ion No)): contains the identification 
number of the group of substances for wh ich the group restriction in Column 1 in 
Table 2 of this Annex applies.  
Column 10 (Restrictions and specifications):  contains other restrictions than the 
specific migration limit specifically mentione d and it contains specifications related 
to the substance. In case detailed specifica tions are set out a refe rence to Table 4 is 
included.  
EN 25   EN Column 11 (Notes on verifica tion of compliance): contains the Notes number which 
refers to the detailed rules applicable for verification of compliance for this substance 
included in Column 1 in Table 3 of this Annex. 
If a substance appearing on the list as an individual co mpound is also covered by a 
generic term, the restrictions  applying to this substance shall be those indicated for 
the individual compound. 
If in Column 8 the specific migration limit is non-detectable (ND) a detection limit 
of 0.01 mg substance per kg food is applicab le unless specified differently for an 
individual substance.  
EN 26   EN Table 1 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No Ref. No CAS No Substance name Use as 
additive 
or 
polymer 
produc-
tion aid 
(yes/no) Use as 
monomer or 
other starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restric-
tion No) Restrictions and 
specifications Notes 
on 
verifi-
cation 
of com-
pliance 
1 12310 0266309-43-7 albumin no yes no     
2 12340 — albumin, coagulated by formaldehyde no yes no     
3 12375 — alcohols, aliphatic, monohydric, 
saturated, linear, primary (C4-C22) no yes no     
4 22332 — mixture of (40 % w/w) 2,2,4-
trimethylhexane-1,6-diisocyanate and 
(60 % w/w) 2,4,4-trimethylhexane-1,6-
diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety. (10) 
5 25360 — trialkyl(C5-C15)acetic acid, 2,3-
epoxypropyl ester no yes no ND  1 mg/kg in final product 
expressed as epoxygroup. 
Molecular weight is 43 Da.  
6 25380 — trialkyl acetic acid (C7-C17), vinyl esters no yes no 0,05   (1) 
7 30370 — acetylacetic acid, salts yes no no     
8 30401 — acetylated mono- and diglycerides of 
fatty acids yes no no  (32)   
9 30610 — acids, C2-C24, aliphatic, linear, 
monocarboxylic from natural oils and 
fats, and their mono-, di- and triglycerol 
esters (branched fatty acids at naturally 
occuring levels are included) yes no no      
EN 27   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
10 30612 — acids, C2-C24, aliphatic, linear, 
monocarboxylic, synthetic and their 
mono-, di- and triglycerol esters yes no no     
11 30960 — acids, aliphatic , monocarboxylic (C6-
C22), esters with polyglycerol yes no no     
12 31328 — acids, fatty, from animal or vegetable 
food fats and oils yes no no     
13 33120 — alcohols, aliphatic, monohydric, 
saturated, linear, primary (C4-C24) yes no no     
14 33801 — n-alkyl(C10-C13)benzenesulphonic acid yes no no 30    
15 34130 — alkyl, linear with even number of carbon 
atoms (C12-C20) dimethylamines yes no yes 30    
16 34230 — alkyl(C8-C22)sulphonic acids yes no no 6    
17 34281 — alkyl(C8-C22)sulphuric acids, linear, 
primary with an even number of carbon 
atoms yes no no     
18 34475 — aluminium calcium hydroxide phosphite, 
hydrate yes no no     
19 39090 — N,N-bis(2-hydroxyethyl)alkyl(C8-
C18)amine yes no no  (7)   
20 39120 — N,N-bis(2-hydroxyethyl)alkyl(C8-
C18)amine hydrochlorides yes no no  (7) SML(T) expressed excluding 
HCl  
21 42500 — carbonic acid, salts yes no no     
22 43200 — castor oil, mono- and diglycerides yes no no     
23 43515 — chlorides of choline esters of coconut oil 
fatty acids yes no no 0,9   (1) 
24 45280 — cotton fibers yes no no     
25 45440 — cresols, butylated, styrenated yes no no 12     
EN 28   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
26 46700 — 5,7-di-tert-butyl-3-(3,4- and 2,3-
dimethylphenyl)-3H-benzofuran-2-one 
containing: a) 5,7-di-tert-butyl-3-(3,4-
dimethylphenyl)-3H-benzofuran-2-one 
(80 to 100 % w/w) and b) 5,7-di-tert-
butyl-3-(2,3-dimethylphenyl)-3H-
benzofuran-2-one (0 to 20 % w/w) yes no no 5    
27 48960 — 9,10-dihydroxy stearic acid and its 
oligomers yes no no 5    
28 50160 — di-n-octyltin bis(n-alkyl(C10-C16) 
mercaptoacetate) yes no no  (10)   
29 50360 — di-n-octyltin bis(ethyl maleate) yes no no  (10)   
30 50560 — di-n-octyltin 1,4-butanediol 
bis(mercaptoacetate) yes no no  (10)   
31 50800 — di-n-octyltin dimaleate, esterified yes no no  (10)   
32 50880 — di-n-octyltin dimaleate, polymers (n = 2-
4) yes no no  (10)   
33 51120 — di-n-octyltin thiobenzoate 2-ethylhexyl 
mercaptoacetate yes no no  (10)   
34 54270 — ethylhydroxymethylcellulose yes no no     
35 54280 — ethylhydroxypropylcellulose yes no no     
36 54450 — fats and oils, from animal or vegetable 
food sources yes no no     
37 54480 — fats and oils, hydrogenated, from animal 
or vegetable food sources yes no no     
38 55520 — glass fibers yes no no     
39 55600 — glass microballs yes no no     
40 56360 — glycerol, esters with acetic acid yes no no      
EN 29   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
41 56486 — glycerol, esters w ith acids, aliphatic, 
saturated, linear, with an even number of 
carbon atoms (C14-C18) and with acids, 
aliphatic, unsaturated, linear, with an 
even number of carbon atoms (C16-C18) yes no no     
42 56487 — glycerol, esters with butyric acid yes no no     
43 56490 — glycerol, esters with erucic acid yes no no     
44 56495 — glycerol, esters with 12-hydroxystearic 
acid yes no no     
45 56500 — glycerol, esters with lauric acid yes no no     
46 56510 — glycerol, esters with linoleic acid yes no no     
47 56520 — glycerol, esters with myristic acid yes no no     
48 56535 — glycerol, esters with nonanoic acid yes no no     
49 56540 — glycerol, esters with oleic acid yes no no     
50 56550 — glycerol, esters with palmitic acid yes no no     
51 56570 — glycerol, esters with propionic acid yes no no     
52 56580 — glycerol, esters with ricinoleic acid yes no no     
53 56585 — glycerol, esters with stearic acid yes no no     
54 57040 — glycerol monooleate,  ester with ascorbic 
acid yes no no     
55 57120 — glycerol monooleate,  ester with citric 
acid yes no no     
56 57200 — glycerol monopa lmitate, ester with 
ascorbic acid yes no no     
57 57280 — glycerol monopalmita te, ester with citric 
acid yes no no     
58 57600 — glycerol monostearate, ester with 
ascorbic acid yes no no      
EN 30   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
59 57680 — glycerol monostearat e, ester with citric 
acid yes no no     
60 58300 — glycine, salts yes no no     
62 64500 — lysine, salts yes no no     
63 65440 — manganese pyrophosphite yes no no     
64 66695 — methylhydroxymethylcellulose yes no no     
65 67155 — mixture of 4-(2-benzoxazolyl)-4'-(5-
methyl-2-benzoxazolyl)stilbene, 4,4'-
bis(2-benzoxazolyl) stilbene and 4,4'-
bis(5-methyl-2-benzoxazolyl)stilbene yes no no   Not more than 0,05 % (w/w) 
(quantity of substance 
used/quantity of the 
formulation). 
Mixture obtained from the manufacturing process in the 
typical ratio of (58-62 
%):(23-27 %):(13-17 %).  
66 67600 — mono-n-octyltin tris(alkyl(C10-C16) 
mercaptoacetate) yes no no  (11)   
67 67840 — montanic acids and/ or their esters with 
ethyleneglycol and/or with 1,3-butanediol 
and/or with glycerol yes no no     
68 73160 — phosphoric acid, mono- and di-n-alkyl 
(C16 and C18) esters yes no yes 0,05    
69 74400 — phosphorous acid, tris(nonyl-and/or 
dinonylphenyl) ester yes no yes 30    
70 76463 — polyacrylic acid, salts yes no no  (22)   
71 76730 — polydimethylsiloxane, γ-
hydroxypropylated yes no no 6    
72 76815 — polyester of adipic acid with glycerol or 
pentaerythritol, esters with even 
numbered, unbranched C12-C22 fatty 
acids yes no no  (32) The fraction with molecular 
weight below 1 000 Da 
should not exceed 5 % (w/w)  
73 76866 — polyesters of 1,2-propanediol and/or 1,3- 
and/or 1,4-butanediol and/or yes no yes  (31) 
(32)    
EN 31   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
polypropyleneglycol with adipic acid, 
which may be end-capped with acetic 
acid or fatty acids C12-C18 or n-octanol 
and/or n-decanol 
74 77440 — polyethyleneglycol diricinoleate yes no yes 42    
75 77702 — polyethyleneglycol esters of aliph. 
monocarb. acids (C6-C22) and their 
ammonium and sodium sulphates yes no no     
76 77732 — polyethylene glycol  (EO=1-30, typically 
5) ether of butyl 2-cyano 3-(4-hydroxy-3-
methoxyphenyl) acrylate yes no no 0,05  Only for use in PET  
77 77733 — polyethyleneglyco l (EO=1-30, typically 
5) ether of butyl-2-cyano-3-(4-
hydroxyphenyl) acrylate yes no no 0,05  Only for use in PET  
78 77897 — polyethyleneglycol (EO =1-50) 
monoalkylether (linear and branched, C8-
C20) sulphate, salts yes no no 5    
79 80640 — polyoxyalkyl (C2-C4) 
dimethylpolysiloxane yes no no     
80 81760 — powders, flakes and fibres of brass, 
bronze, copper, stainless steel, tin, iron 
and alloys of copper, tin and iron yes no no     
81 83320 — propylhydroxyethylcellulose yes no no     
82 83325 — propylhydroxymethylcellulose yes no no     
83 83330 — propylhydroxypropylcellulose yes no no     
84 85601 — silicates, natural (with the exception of 
asbestos) yes no no     
85 85610 — silicates, natural, silanated (with the 
exception of asbestos) yes no no     
86 86000 — silicic acid, silylated yes no no     
87 86285 — silicon dioxide, silanated yes no no      
EN 32   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
88 86880 — sodium monoalkyl 
dialkylphenoxybenzenedisulphonate yes no no 9    
89 89440 — stearic acid, esters with ethyleneglycol yes no no  (2)   
90 92195 — taurine, salts yes no no     
91 92320 — tetradecyl-polyethyleneglycol(EO=3-8) 
ether of glycolic acid yes no yes 15    
92 93970 — tricyclodecanedimethanol 
bis(hexahydrophthalate) yes no no 0,05    
93 95858 — waxes, paraffinic, refined, derived from 
petroleum based or synthetic 
hydrocarbon feedstocks, low viscosity yes no no 0,05  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid down. 
Average molecular weight 
not less than 350 Da. 
Viscosity at 100 °C not less 
than 2,5 cSt (2,5 x 10
-6 m2/s).
Content of hydrocarbons with 
Carbon number less than 25, 
not more than 40 % (w/w).  
94 95859 — waxes, refined, derived from petroleum 
based or synthetic hydrocarbon 
feedstocks, high viscosity yes no no   Average molecular weight 
not less than 500 Da. 
Viscosity at 100 °C not less 
than 11 cSt (11 x 10-6 m2/s). 
Content of mineral 
hydrocarbons with Carbon 
number less than 25, not more 
than 5 % (w/w).  
95 95883 — white mineral oils, paraffinic, derived 
from petroleum based hydrocarbon 
feedstocks yes no no   Average molecular weight 
not less than 480 Da. 
Viscosity at 100 °C not less 
than 8,5 cSt (8,5 x 10-6 m2/s). 
Content of mineral 
hydrocarbons with Carbon 
number less than 25, not more 
than 5 % (w/w).   
EN 33   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
96 95920 — wood flour and fibers, untreated yes no no     
97 72081/1
0 — petroleum hydrocarbon resins 
(hydrogenated) yes no no   Petroleum hydrocarbon 
resins, hydrogenated are 
produced by the catalytic or 
thermalpolymerisation of 
dienes and olefins of the 
aliphatic, alicyclic and/or 
monobenzenoidarylalkene 
types from distillates of 
cracked petroleum stocks 
with a boiling range not 
greater than 220 °C, as well 
as the pure monomers found 
in these distillation streams, 
subsequently followed by 
distillation, hydrogenation 
and additional processing. 
Properties: 
— Viscosity at 120 °C : > 3 
Pa.s 
— Softening point: > 95 °C 
as determined by ASTM Method E 28-67 
— Bromine number: < 40 
(ASTM D1159) 
— The colour of a 50 % 
solution in toluene < 11 
on the Gardner scale 
— Residual aromatic 
monomer ≤ 50 ppm.   
EN 34   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
17260 98 
54880 0000050-00-0 formaldehyde yes yes no  (15)   
19460 99 
62960 0000050-21-5 lactic acid yes yes no     
24490 100 
88320 0000050-70-4 sorbitol yes yes no     
101 36000 0000050-81-7 ascorbic acid yes no no     
102 17530 0000050-99-7 glucose no yes no     
18100 103 
55920 0000056-81-5 glycerol yes yes no     
104 58960 0000057-09-0 hexadecyltrimethylamm onium bromide yes no no 6    
22780 105 
70400 0000057-10-3 palmitic acid yes yes no     
24550 106 
89040 0000057-11-4 stearic acid yes yes no     
107 25960 0000057-13-6 urea no yes no     
108 24880 0000057-50-1 sucrose no yes no     
23740 109 
81840 0000057-55-6 1,2-propanediol yes yes no     
110 93520 0000059-02-9 
0010191-41-0 α-tocopherol yes no no     
111 53600 0000060-00-4 ethylenediaminetetraacetic acid yes no no     
112 64015 0000060-33-3 linoleic acid yes no no     
16780 113 
52800 0000064-17-5 ethanol yes yes no      
EN 35   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
114 55040 0000064-18-6 formic acid yes no no     
10090 115 
30000 0000064-19-7 acetic acid yes yes no     
13090 116 
37600 0000065-85-0 benzoic acid yes yes no     
117 21550 0000067-56-1 methanol no yes no     
23830 118 
81882 0000067-63-0 2-propanol yes yes no     
119 30295 0000067-64-1 acetone yes no no     
120 49540 0000067-68-5 dimethyl sulphoxide yes no no     
24270 121 
84640 0000069-72-7 salicylic acid yes yes no     
122 23800 0000071-23-8 1-propanol no yes no     
123 13840 0000071-36-3 1-butanol no yes no     
124 22870 0000071-41-0 1-pentanol no yes no     
125 16950 0000074-85-1 ethylene no yes no     
126 10210 0000074-86-2 acetylene no yes no     
127 26050 0000075-01-4 vinyl chloride no yes no ND  1 mg/kg in final product  
128 10060 0000075-07-0 acetaldehyde no yes no  (1)   
129 17020 0000075-21-8 ethylene oxide no yes no ND  1 mg/kg in final product (10) 
130 26110 0000075-35-4 vinylidene chloride no yes no ND   (1) 
131 48460 0000075-37-6 1,1-difluoroethane yes no no     
132 26140 0000075-38-7 vinylidene fluoride no yes no 5    
14380 133 
23155 0000075-44-5 carbonyl chloride no yes no ND  1 mg/kg in final product (10)  
EN 36   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
134 43680 0000075-45-6 chlorodifluoromethane yes no no 6  Content of 
chlorofluoromethane less than 
1 mg/kg of the substance  
135 24010 0000075-56-9 propylene oxide no yes no ND  1 mg/kg in final product  
136 41680 0000076-22-2 camphor yes no no    (3) 
137 66580 0000077-62-3 2,2'-methylenebis(4-methyl-6-(1-
methylcyclohexyl)phenol) yes no yes  (5)   
138 93760 0000077-90-7 tri-n-butyl acetyl citrate yes no no  (32)   
14680 139 
44160 0000077-92-9 citric acid yes yes no     
140 44640 0000077-93-0 citric acid, triethyl ester yes no no  (32)   
13380 
25600 141 
94960 0000077-99-6 1,1,1-trimethylolpropane yes yes no 6    
142 26305 0000078-08-0 vinyltriethoxysilane no yes no 0,05  Only to be used as a surface 
treatment agent (1) 
143 62450 0000078-78-4 isopentane yes no no     
19243 144 
21640 0000078-79-5 2-methyl-1,3-butadiene no yes no ND  1 mg/kg in final product  
145 10630 0000079-06-1 acrylamide no yes no ND    
23890 146 
82000 0000079-09-4 propionic acid yes yes no     
147 10690 0000079-10-7 acrylic acid no yes no  (22)   
148 14650 0000079-38-9 chlorotrifluoroethylene no yes no ND   (1) 
149 19990 0000079-39-0 methacrylamide no yes no ND    
150 20020 0000079-41-4 methacrylic acid no yes no  (23)    
EN 37   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
13480 151 
13607 0000080-05-7 2,2-bis(4-hydroxyphenyl)propane no yes no 0,6    
152 15610 0000080-07-9 4,4'-dichlorodiphenyl sulphone no yes no 0,05    
153 15267 0000080-08-0 4,4'-diaminodiphenyl sulphone no yes no 5    
13617 154 
16090 0000080-09-1 4,4'-dihydroxydiphenyl sulphone no yes no 0,05    
155 23470 0000080-56-8 α-pinene no yes no     
156 21130 0000080-62-6 methacrylic acid, methyl ester no yes no  (23)   
157 74880 0000084-74-2 phthalic acid, dibutyl ester ye s no no 0,3 (32) Only to be used as: 
(a) plasticizer in repeated use 
materials and articles contacting non-fatty 
foods; 
(b) technical support agent in 
polyolefins in 
concentrations up to 
0,05 % in the final 
product. (7) 
23380 158 
76320 0000085-44-9 phthalic anhydride yes yes no     
159 74560 0000085-68-7 phthalic acid, benzyl butyl ester yes no no 30 (32) Only to be used as:  
(a) plasticizer in repeated use 
materials and articles;  
(b) plasticizer in single-use 
materials and articles 
contacting non-fatty foods 
except for infant formulae 
and follow-on formulae as 
defined by Directive 
2006/141/EC or processed 
cereal-based foods and (7)  
EN 38   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
baby foods for infants and 
young children as defined 
by Directive 
2006/125/EC;  
(c) technical support agent in 
concentrations up to 0,1 % 
in the final product. 
160 84800 0000087-18-3 salicylic acid, 4-tert-butylphenyl ester yes no yes 12    
161 92160 0000087-69-4 tartaric acid yes no no     
162 65520 0000087-78-5 mannitol yes no no     
163 66400 0000088-24-4 2,2'-methylene bis(4-ethyl-6-tert-
butylphenol) yes no yes  (13)   
164 34895 0000088-68-6 2-aminobenzamide yes no no 0,05  Only for use in PET for water 
and beverages  
23200 165 
74480 0000088-99-3 o-phthalic acid  yes yes no     
166 24057 0000089-32-7 pyromellitic anhydride no yes no 0,05    
167 25240 0000091-08-7 2,6-toluene diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
13075 168 
15310 0000091-76-9 2,4-diamino-6-phenyl-1,3,5-triazine no yes no 5   (1) 
169 16240 0000091-97-4 3,3'-dimethyl-4,4'-diisocyanatobiphenyl no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
170 16000 0000092-88-6 4,4'-dihydroxybiphenyl no yes no 6    
171 38080 0000093-58-3 benzoic acid, methyl ester yes no no     
172 37840 0000093-89-0 benzoic acid, ethyl ester yes no no     
173 60240 0000094-13-3 4-hydroxybenzoic acid, propyl ester yes no no      
EN 39   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
174 14740 0000095-48-7 o-cresol  no yes no     
175 20050 0000096-05-9 methacrylic acid, allyl ester no yes no 0,05    
176 11710 0000096-33-3 acrylic acid, methyl ester no yes no  (22)   
177 16955 0000096-49-1 ethylene carbonate no yes no 30  SML expressed as 
ethyleneglycol. 
Residual content of 5 mg 
ethylene carbonate per kg of 
hydrogel with max 10 g of 
hydrogel in contact with 1 kg 
of food.  
178 92800 0000096-69-5 4,4'-thiobis(6-tert-butyl-3-methylphenol) yes no yes 0,48    
179 48800 0000097-23-4 2,2'-dihydroxy-5,5'-
dichlorodiphenylmethane yes no yes 12    
180 17160 0000097-53-0 eugenol no yes no ND    
181 20890 0000097-63-2 methacrylic acid, ethyl ester no yes no  (23)   
182 19270 0000097-65-4 itaconic acid no yes no     
183 21010 0000097-86-9 methacrylic acid, isobutyl ester no yes no  (23)   
184 20110 0000097-88-1 methacrylic acid, butyl ester no yes no  (23)   
185 20440 0000097-90-5 methacrylic acid, diester with 
ethyleneglycol no yes no 0,05    
186 14020 0000098-54-4 4-tert-butylphenol no yes no 0,05    
187 22210 0000098-83-9 α-methylstyrene no yes no 0,05    
188 19180 0000099-63-8 isophthalic acid dichloride no yes no  (27)   
189 60200 0000099-76-3 4-hydroxybenzoic acid, methyl ester yes no no     
190 18880 0000099-96-7 p-hydroxybenzoic acid  no yes no     
191 24940 0000100-20-9 terephthalic acid dichloride no yes no  (28)   
192 23187 — phthalic acid no yes no  (28)   
193 24610 0000100-42-5 styrene no yes no      
EN 40   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
194 13150 0000100-51-6 benzyl alcohol no yes no     
195 37360 0000100-52-7 benzaldehyde yes no no    (3) 
18670 196 
59280 0000100-97-0 hexamethylenetetramine yes yes no  (15)   
197 20260 0000101-43-9 methacrylic acid, cyclohexyl ester no yes no 0,05    
198 16630 0000101-68-8 diphenylmethane-4,4'-diisocyanate  no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
199 24073 0000101-90-6 resorcinol diglycidyl ether no ye s no ND  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down. 
For indirect food contact 
only, behind a PET layer. (8) 
200 51680 0000102-08-9 N,N'-diphenylthiourea yes no yes 3    
201 16540 0000102-09-0 diphenyl carbonate no yes no 0,05    
202 23070 0000102-39-6 (1,3-phenylenedioxy)diacetic acid no yes no 0,05   (1) 
203 13323 0000102-40-9 1,3-bis(2-hydroxyethoxy)benzene no yes no 0,05    
25180 204 
92640 0000102-60-3 N,N,N',N'-tetrakis(2-
hydroxypropyl)ethylenediamine yes yes no     
205 25385 0000102-70-5 triallylamine no yes no   40 mg/kg hydrogel at a ratio 
of 1 kg food to a maximum of 1,5 grams of hydrogel. 
Only to be used in hydrogels 
intended for non-direct food 
contact use.  
206 11500 0000103-11-7 acrylic acid, 2-ethylhexyl ester no yes no 0,05    
207 31920 0000103-23-1 adipic acid, bis(2-ethylhexyl) ester yes no yes 18 (32)  (2) 
208 18898 0000103-90-2 N-(4-hydroxyphenyl) acetamide no yes no 0,05     
EN 41   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
209 17050 0000104-76-7 2-ethyl-1-hexanol no yes no 30    
13390 210 
14880 0000105-08-8 1,4-bis(hydroxymethyl)cyclohexane no yes no     
211 23920 0000105-38-4 propionic acid, vinyl ester no yes no  (1)   
14200 212 
41840 0000105-60-2 caprolactam yes yes no  (4)   
213 82400 0000105-62-4 1,2-propyleneglycol dioleate yes no no     
214 61840 0000106-14-9 12-hydroxystearic acid yes no no     
215 14170 0000106-31-0 butyric anhydride no yes no     
216 14770 0000106-44-5 p-cresol  no yes no     
217 15565 0000106-46-7 1,4-dichlorobenzene no yes no 12    
218 11590 0000106-63-8 acrylic acid, isobutyl ester no yes no  (22)   
14570 219 
16750 0000106-89-8 epichlorohydrin no yes no ND  1 mg/kg in final product (10) 
220 20590 0000106-91-2 methacrylic acid, 2,3-epoxypropyl ester no yes no 0,02   (10) 
221 40570 0000106-97-8 butane yes no no     
222 13870 0000106-98-9 1-butene no yes no     
223 13630 0000106-99-0 butadiene no yes no ND  1 mg/kg in final product  
224 13900 0000107-01-7 2-butene no yes no     
225 12100 0000107-13-1 acrylonitrile no yes no ND    
15272 226 
16960 0000107-15-3 ethylenediamine no yes no 12    
16990 227 
53650 0000107-21-1 ethyleneglycol yes yes no  (2)   
228 13690 0000107-88-0 1,3-butanediol no yes no      
EN 42   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
229 14140 0000107-92-6 butyric acid no yes no     
230 16150 0000108-01-0 dimethylaminoethanol no yes no 18    
231 10120 0000108-05-4 acetic acid, vinyl ester no yes no 12    
10150 232 
30280 0000108-24-7 acetic anhydride yes yes no     
233 24850 0000108-30-5 succinic anhydride no yes no     
234 19960 0000108-31-6 maleic anhydride no yes no  (3)   
235 14710 0000108-39-4 m-cresol  no yes no     
236 23050 0000108-45-2 1,3-phenylenediamine no yes no ND    
15910 237 
24072 0000108-46-3 1,3-dihydroxybenzene no yes no 2,4    
238 18070 0000108-55-4 glutaric anhydride no yes no     
19975 
25420 239 
93720 0000108-78-1 2,4,6-triamino-1,3,5-triazine yes yes no 30    
240 45760 0000108-91-8 cyclohexylamine yes no no     
241 22960 0000108-95-2 phenol no yes no     
242 85360 0000109-43-3 sebacic acid, dibutyl ester yes no no  (32)   
243 19060 0000109-53-5 isobutyl vinyl ether no yes no 0,05   (10) 
244 71720 0000109-66-0 pentane yes no no     
245 22900 0000109-67-1 1-pentene no yes no 5    
246 25150 0000109-99-9 tetrahydrofuran no yes no 0,6    
24820 247 
90960 0000110-15-6 succinic acid yes yes no     
248 19540 0000110-16-7 maleic acid yes yes no  (3)    
EN 43   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
64800 
17290 249 
55120 0000110-17-8 fumaric acid yes yes no     
250 53520 0000110-30-5 N,N'-ethylenebisstearamide yes no no     
251 53360 0000110-31-6 N,N'-ethylenebisoleamide yes no no     
252 87200 0000110-44-1 sorbic acid yes no no     
253 15250 0000110-60-1 1,4-diaminobutane no yes no     
13720 254 
40580 0000110-63-4 1,4-butanediol yes yes no  (30)   
255 25900 0000110-88-3 trioxane no yes no 5    
18010 256 
55680 0000110-94-1 glutaric acid yes yes no     
13550 
16660 257 
51760 0000110-98-5 dipropyleneglycol yes yes no     
258 70480 0000111-06-8 palmitic acid, butyl ester yes no no     
259 58720 0000111-14-8 heptanoic acid yes no no     
260 24280 0000111-20-6 sebacic acid no yes no     
261 15790 0000111-40-0 diethylenetriamine no yes no 5    
262 35284 0000111-41-1 N-(2-aminoethyl)ethanolamine yes no no 0,05  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid down. 
For indirect food contact 
only, behind a PET layer.  
13326 263 
15760 0000111-46-6 diethyleneglycol yes yes no  (2)    
EN 44   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
47680 
264 22660 0000111-66-0 1-octene no yes no 15    
265 22600 0000111-87-5 1-octanol no yes no     
25510 266 
94320 0000112-27-6 triethyleneglycol yes yes no     
267 15100 0000112-30-1 1-decanol no yes no     
268 16704 0000112-41-4 1-dodecene no yes no 0,05    
25090 269 
92350 0000112-60-7 tetraethyleneglycol yes yes no     
22763 270 
69040 0000112-80-1 oleic acid yes yes no     
271 52720 0000112-84-5 erucamide yes no no     
272 37040 0000112-85-6 behenic acid yes no no     
273 52730 0000112-86-7 erucic acid yes no no     
274 22570 0000112-96-9 octadecyl isocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
275 23980 0000115-07-1 propylene no yes no     
276 19000 0000115-11-7 isobutene no yes no     
277 18280 0000115-27-5 hexachloroendomethylenetetrahydrophth
alic anhydride no yes no ND    
278 18250 0000115-28-6 hexachloroendomethylenetetrahydrophth
alic acid no yes no ND    
22840 279 
71600 0000115-77-5 pentaerythritol yes yes no     
280 73720 0000115-96-8 phosphoric acid, trichloroethyl ester yes no no ND     
EN 45   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
281 25120 0000116-14-3 tetrafluoroethylene no yes no 0,05    
282 18430 0000116-15-4 hexafluoropropylene no yes no ND    
283 74640 0000117-81-7 phthalic acid, bis(2-ethylhexyl) ester yes no no 1,5 (32) Only to be used as: 
(a) plasticizer in repeated use 
materials and articles 
contacting non-fatty 
foods; 
(b) technical support agent in 
concentrations up to 0,1 % 
in the final product. (7) 
284 84880 0000119-36-8 salicylic acid, methyl ester yes no no 30    
285 66480 0000119-47-1 2,2'-methylene bis(4-methyl-6-tert-
butylphenol) yes no yes  (13)   
286 38240 0000119-61-9 benzophenone yes no yes 0,6    
287 60160 0000120-47-8 4-hydroxybenzoic acid, ethyl ester yes no no     
288 24970 0000120-61-6 terephthalic acid, dimethyl ester no yes no     
15880 289 
24051 0000120-80-9 1,2-dihydroxybenzene no yes no 6    
290 55360 0000121-79-9 gallic acid, propyl ester yes no no  (20)   
291 19150 0000121-91-5 isophthalic acid no yes no  (27)   
292 94560 0000122-20-3 triisopropanolamine yes no no 5    
293 23175 0000122-52-1 phosphorous acid, triethyl ester no yes no ND  1 mg/kg in final product (1) 
294 93120 0000123-28-4 thiodipropionic acid, didodecyl ester yes no yes  (14)   
15940 
18867 295 
48620 0000123-31-9 1,4-dihydroxybenzene yes yes no 0,6    
296 23860 0000123-38-6 propionaldehyde no yes no      
EN 46   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
297 23950 0000123-62-6 propionic anhydride no yes no     
298 14110 0000123-72-8 butyraldehyde no yes no     
299 63840 0000123-76-2 levulinic acid yes no no     
300 30045 0000123-86-4 acetic acid, butyl ester yes no no     
301 89120 0000123-95-5 stearic acid, butyl ester yes no no     
302 12820 0000123-99-9 azelaic acid no yes no     
12130 303 
31730 0000124-04-9 adipic acid yes yes no     
14320 304 
41960 0000124-07-2 caprylic acid yes yes no     
15274 305 
18460 0000124-09-4 hexamethylenediamine no yes no 2,4    
306 88960 0000124-26-5 stearamide yes no no     
307 42160 0000124-38-9 carbon dioxide yes no no     
308 91200 0000126-13-6 sucrose acetate isobutyrate yes no no     
309 91360 0000126-14-7 sucrose octaacetate yes no no     
16390 310 
22437 0000126-30-7 2,2-dimethyl-1,3-propanediol no yes no 0,05    
16480 311 
51200 0000126-58-9 dipentaerythritol yes yes no     
312 21490 0000126-98-7 methacrylonitrile no yes no ND    
16650 313 
51570 0000127-63-9 diphenyl sulphone yes yes no 3    
314 23500 0000127-91-3 β-pinene no yes no     
315 46640 0000128-37-0 2,6-di-tert-butyl-p-cresol yes no no 3     
EN 47   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
316 23230 0000131-17-9 phthalic acid, diallyl ester no yes no ND    
317 48880 0000131-53-3 2,2'-dihydroxy-4-methoxybenzophenone yes no yes  (8)   
318 48640 0000131-56-6 2,4-dihydroxybenzophenone yes no no  (8)   
319 61360 0000131-57-7 2-hydroxy-4-methoxybenzophenone yes no yes  (8)   
320 37680 0000136-60-7 benzoic acid, butyl ester yes no no     
321 36080 0000137-66-6 ascorbyl palmitate yes no no     
322 63040 0000138-22-7 lactic acid, butyl ester yes no no     
323 11470 0000140-88-5 acrylic acid, ethyl ester no yes no  (22)   
324 83700 0000141-22-0 ricinoleic acid yes no yes 42    
325 10780 0000141-32-2 acrylic acid, n-butyl ester no yes no  (22)   
12763 326 
35170 0000141-43-5 2-aminoethanol yes yes no 0,05  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down. 
For indirect food contact 
only, behind a PET layer.  
327 30140 0000141-78-6 acetic acid, ethyl ester yes no no     
328 65040 0000141-82-2 malonic acid yes no no     
329 59360 0000142-62-1 hexanoic acid yes no no     
19470 330 
63280 0000143-07-7 lauric acid yes yes no     
331 22480 0000143-08-8 1-nonanol no yes no     
332 69760 0000143-28-2 oleyl alcohol yes no no     
22775 333 
69920 0000144-62-7 oxalic acid yes yes no 6    
334 17005 0000151-56-4 ethyleneimine no yes no ND    
335 68960 0000301-02-0 oleamide yes no no      
EN 48   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
15095 336 
45940 0000334-48-5 n-decanoic acid yes yes no     
337 15820 0000345-92-6 4,4'-difluorobenzophenone no yes no 0,05    
338 71020 0000373-49-9 palmitoleic acid yes no no     
339 86160 0000409-21-2 silicon carbide yes no no     
340 47440 0000461-58-5 dicyanodiamide yes no no     
13180 341 
22550 0000498-66-8 bicyclo[2.2.1]hept-2 -ene no yes no 0,05    
342 14260 0000502-44-3 caprolactone no yes no  (29)   
343 23770 0000504-63-2 1,3-propanediol no yes no 0,05    
13810 344 
21821 0000505-65-7 1,4-butanediol formal no yes no ND   (10) 
345 35840 0000506-30-9 arachidic acid yes no no     
346 10030 0000514-10-3 abietic acid no yes no     
13050 347 
25540 0000528-44-9 trimellitic acid no yes no  (21)   
22350 348 
67891 0000544-63-8 myristic acid yes yes no     
349 25550 0000552-30-7 trimellitic anhydride no yes no  (21)   
350 63920 0000557-59-5 lignoceric acid yes no no     
351 21730 0000563-45-1 3-methyl-1-butene no yes no ND  Only to be used in 
polypropylene (1) 
352 16360 0000576-26-1 2,6-dimethylphenol no yes no 0,05    
353 42480 0000584-09-8 carbonic acid, rubidium salt yes no no 12    
354 25210 0000584-84-9 2,4-toluene diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate (10)  
EN 49   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
moiety 
355 20170 0000585-07-9 methacrylic acid, tert-butyl ester no yes no  (23)   
356 18820 0000592-41-6 1-hexene no yes no 3    
357 13932 0000598-32-3 3-buten-2-ol no yes no ND  Only to be used as a co-
monomer for the preparation 
of polymeric additive (1) 
358 14841 0000599-64-4 4-cumylphenol no yes no 0,05    
15970 359 
48720 0000611-99-4 4,4'-dihydroxybenzophenone yes yes no  (8)   
360 57920 0000620-67-7 glycerol triheptanoate yes no no     
361 18700 0000629-11-8 1,6-hexanediol no yes no 0,05    
362 14350 0000630-08-0 carbon monoxide no yes no     
363 16450 0000646-06-0 1,3-dioxolane no yes no 5    
364 15404 0000652-67-5 1,4:3,6-dianhydrosorbitol no yes no 5  Only to be used as a co-
monomer in poly(ethylene-
co-isosorbide terephthalate)  
365 11680 0000689-12-3 acrylic acid, isopropyl ester no yes no  (22)   
366 22150 0000691-37-2 4-methyl-1-pentene no yes no 0,05    
367 16697 0000693-23-2 n-dodecanedioic acid no yes no     
368 93280 0000693-36-7 thiodipropionic acid, dioc tadecyl ester yes no yes  (14)   
369 12761 0000693-57-2 12-aminododecanoic acid no yes no 0,05    
370 21460 0000760-93-0 methacrylic anhydride no yes no  (23)   
11510 371 
11830 0000818-61-1 acrylic acid, monoester with 
ethyleneglycol no yes no  (22)   
372 18640 0000822-06-0 hexamethylene diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10)  
EN 50   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
373 22390 0000840-65-3 2,6-naphthalenedicarboxylic acid, 
dimethyl ester no yes no 0,05    
374 21190 0000868-77-9 methacrylic acid, monoester with 
ethyleneglycol no yes no  (23)   
375 15130 0000872-05-9 1-decene no yes no 0,05    
376 66905 0000872-50-4 N-methylpyrrolidone yes no no     
377 12786 0000919-30-2 3-aminopropyltriethoxysilane no yes no 0,05  Residual extractable content 
of 3-
aminopropyltriethoxysilane to 
be less than 3 mg/kg filler 
when used for the reactive 
surface treatment of inorganic 
fillers. 
 
SML = 0,05 mg/kg when 
used for the surface treatment 
of materials and articles.  
378 21970 0000923-02-4 N-methylolmethacrylamide no yes no 0,05    
379 21940 0000924-42-5 N-methylolacrylamide no yes no ND    
380 11980 0000925-60-0 acrylic acid, propyl ester no yes no  (22)   
381 15030 0000931-88-4 cyclooctene no yes no 0,05  Only to be used in polymers 
contacting foods for which 
simulant A is laid down  
382 19490 0000947-04-6 laurolactam no yes no 5    
383 72160 0000948-65-2 2-phenylindole yes no yes 15    
384 40000 0000991-84-4 2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-
di-tert-butylanilino)-1,3,5-triazine yes no yes 30    
385 11530 0000999-61-1 acrylic acid, 2-hydroxypropyl ester no yes no 0,05  SML expressed as the sum of 
acrylic acid, 2-hydroxypropyl 
ester and acrylic acid, 2-
hydroxyisopropyl ester. 
 
It may contain up to 25 % (1)  
EN 51   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
(m/m) of acrylic acid, 2-
hydroxyisopropyl ester (CAS 
No 0002918-23-2). 
386 55280 0001034-01-1 gallic acid, octyl ester yes no no  (20)   
387 26155 0001072-63-5 1-vinylimidazole no yes no 0,05   (1) 
388 25080 0001120-36-1 1-tetradecene no yes no 0,05    
389 22360 0001141-38-4 2,6-naphthalenedicarboxylic acid no yes no 5    
390 55200 0001166-52-5 gallic acid, dodecyl ester yes no no  (20)   
391 22932 0001187-93-5 perfluoromethyl perfluorovinyl ether no ye s no 0,05  Only to be used in anti-stick 
coatings  
392 72800 0001241-94-7 phosphoric acid, diphenyl 2-ethylhexyl 
ester yes no yes 2,4    
393 37280 0001302-78-9 bentonite yes no no     
394 41280 0001305-62-0 calcium hydroxide yes no no     
395 41520 0001305-78-8 calcium oxide yes no no     
396 64640 0001309-42-8 magnesium hydroxide yes no no     
397 64720 0001309-48-4 magnesium oxide yes no no     
398 35760 0001309-64-4 antimony trioxide yes no no 0,04  SML expressed as antimony (6) 
399 81600 0001310-58-3 potassium hydroxide yes no no     
400 86720 0001310-73-2 sodium hydroxide yes no no     
401 24475 0001313-82-2 sodium sulphide no yes no     
402 96240 0001314-13-2 zinc oxide yes no no     
403 96320 0001314-98-3 zinc sulphide yes no no     
404 67200 0001317-33-5 molybdenum disulphide yes no no     
405 16690 0001321-74-0 divinylbenzene no yes no ND  SML expressed as the sum of 
divinylbenzene and 
ethylvinylbenzene. 
It may contain up to 45 % (1)  
EN 52   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
(m/m) of ethylvinylbenzene. 
406 83300 0001323-39-3 1,2-propyleneglycol monostearate yes no no     
407 87040 0001330-43-4 sodium tetraborate yes no no  (16)   
408 82960 0001330-80-9 1,2-propyleneglycol monooleate yes no no     
409 62240 0001332-37-2 iron oxide yes no no     
410 62720 0001332-58-7 kaolin yes no no     
411 42080 0001333-86-4 carbon black yes no no   Primary particles of 10 - 300 
nm which are aggregated to a 
size of 100 - 1200 nm which 
may form agglomerates 
within the size distribution of 
300nm - mm. 
 
Toluene extractables: 
maximum 0,1 %, determined 
according to ISO method 
6209. 
 
UV absorption of 
cyclohexane extract at 386 
nm: < 0,02 AU for a 1 cm cell 
or < 0,1 AU for a 5 cm cell, 
determined according to a 
generally recognised method 
of analysis. 
 
Benzo(a)pyrene content: max 
0,25 mg/kg carbon black. 
 
Maximum use level of carbon 
black in the polymer: 2,5 % 
w/w.  
412 45200 0001335-23-5 copper iodide yes no no  (6)   
413 35600 0001336-21-6 ammonium hydroxide yes no no     
414 87600 0001338-39-2 sorbitan monolaurate yes no no      
EN 53   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
415 87840 0001338-41-6 sorbitan monostearate yes no no     
416 87680 0001338-43-8 sorbitan monooleate yes no no     
417 85680 0001343-98-2 silicic acid yes no no     
418 34720 0001344-28-1 aluminium oxide yes no no     
419 92150 0001401-55-4 tannic acids yes no no   According to the JECFA 
specifications  
420 19210 0001459-93-4 isophthalic acid, dimethyl ester no yes no 0,05    
421 13000 0001477-55-0 1,3-benzenedimethanamine no yes no 0,05    
422 38515 0001533-45-5 4,4'-bis(2-benzoxazolyl)stilbene yes no yes 0,05   (2) 
423 22937 0001623-05-8 perfluoropropylperfluorovinyl ether no yes no 0,05    
424 15070 0001647-16-1 1,9-decadiene no yes no 0,05    
425 10840 0001663-39-4 acrylic acid, tert-butyl ester no yes no  (22)   
13510 426 
13610 0001675-54-3 2,2-bis(4-hydroxyphenyl)propane 
bis(2,3-epoxypropyl) ether no yes no   In compliance with 
Commission Regulation (EC) 
No 1895/200519   
427 18896 0001679-51-2 4-(hydroxymethyl)-1-cyclohexene no yes no 0,05    
428 95200 0001709-70-2 1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-
butyl-4-hydroxybenzyl)benzene yes no no     
429 13210 0001761-71-3 bis(4-aminocyclohexyl)methane no yes no 0,05    
430 95600 0001843-03-4 1,1,3-tris(2-methyl-4-hydroxy-5-tert-
butylphenyl) butane yes no yes 5    
431 61600 0001843-05-6 2-hydroxy-4-n-octyloxybenzophenone yes no yes  (8)   
432 12280 0002035-75-8 adipic anhydride no yes no     
433 68320 0002082-79-3 octadecyl 3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate yes no yes 6    
                                                 
19 OJ L 302, 19.11.2005, p. 28   
EN 54   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
434 20410 0002082-81-7 methacrylic ac id, diester with 1,4-
butanediol no yes no 0,05    
435 14230 0002123-24-2 caprolactam, sodium salt no yes no  (4)   
436 19480 0002146-71-6 lauric acid, vinyl ester no yes no     
437 11245 0002156-97-0 acrylic acid, dodecyl ester no yes no 0,05   (2) 
438 38875 0002162-74-5 bis(2,6-diisopropylphenyl) carbodiimid e yes no no 0,05  For indirect food contact 
only, behind a PET layer  
439 21280 0002177-70-0 methacrylic acid, phenyl ester no yes no  (23)   
440 21340 0002210-28-8 methacrylic acid, propyl ester no yes no  (23)   
441 38160 0002315-68-6 benzoic acid, propyl ester yes no no     
442 13780 0002425-79-8 1,4-butanediol bis(2,3-epoxypropyl)et her no yes no ND  Residual content = 1 mg/kg in 
final product expressed as 
epoxygroup. 
 
Molecular weight is 43 Da. (10) 
443 12788 0002432-99-7 11-aminoundecanoic acid no yes no 5    
444 61440 0002440-22-4 2-(2'-hydroxy-5'-
methylphenyl)benzotriazole yes no no  (12)   
445 83440 0002466-09-3 pyrophosphoric acid yes no no     
446 10750 0002495-35-4 acrylic acid, benzyl ester no yes no  (22)   
447 20080 0002495-37-6 methacrylic acid, benzyl ester no yes no  (23)   
448 11890 0002499-59-4 acrylic acid, n-octyl ester no yes no  (22)   
449 49840 0002500-88-1 dioctadecyl disu lphide yes no yes 3    
450 24430 0002561-88-8 sebacic anhydride no yes no     
451 66755 0002682-20-4 2-methyl-4-isothiazolin-3-one yes no no 0,5  Only to be used in aqueous 
polymer dispersions and 
emulsions  
452 38885 0002725-22-6 2,4-bis(2,4-dimethylphenyl)-6-(2-
hydroxy-4-n-octyloxyphenyl)-1,3,5-yes no no 0,05  Only to be used in aqueous 
foods   
EN 55   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
triazine 
453 26320 0002768-02-7 vinyltrimethoxysilane no yes no 0,05   (10) 
454 12670 0002855-13-2 1-amino-3-aminomethyl-3,5,5-
trimethylcyclohexane no yes no 6    
455 20530 0002867-47-2 methacrylic acid, 2-(dimethylamino)-
ethyl ester no yes no ND    
456 10810 0002998-08-5 acrylic acid, sec-butyl ester no yes no  (22)   
457 20140 0002998-18-7 methacrylic acid, sec-butyl ester no yes no  (23)   
458 36960 0003061-75-4 behenamide yes no no     
459 46870 0003135-18-0 3,5-di-tert-butyl-4-
hydroxybenzylphosphonic acid, 
dioctadecyl ester yes no no     
460 14950 0003173-53-3 cyclohexyl isocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
461 22420 0003173-72-6 1,5-naphthalene diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
462 26170 0003195-78-6 N-vinyl-N-methylacetamide no yes no 0,02   (1) 
463 25840 0003290-92-4 1,1,1-trimethylolpropane trimethacrylate no yes no 0,05    
464 61280 0003293-97-8 2-hydroxy-4-n-hexyloxybenzophenone yes no yes  (8)   
465 68040 0003333-62-8 7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-
phenylcoumarin yes no no     
466 50640 0003648-18-8 di-n-octyltin dilaurate yes no no  (10)   
14800 467 
45600 0003724-65-0 crotonic acid yes yes no 0,05   (1) 
468 71960 0003825-26-1 perfluorooctanoic acid, ammonium salt ye s no no   Only to be used in repeated 
use articles, sintered at high 
temperatures   
EN 56   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
469 60480 0003864-99-1 2-(2'-hydroxy-3,5'-di-tert-butylphenyl)-5-
chlorobenzotriazole yes no yes  (12)   
470 60400 0003896-11-5 2-(2'-hydroxy-3'-tert-butyl-5'-
methylphenyl)-5-chlorobenzotriazole yes no yes  (12)   
471 24888 0003965-55-7 5-sulphoisophthalic acid, monosodium 
salt, dimethyl ester no yes no 0,05    
472 66560 0004066-02-8 2,2'-methylenebis(4-methyl-6-
cyclohexylphenol) yes no yes  (5)   
473 12265 0004074-90-2 adipic acid, divinyl ester no yes no ND  5 mg/kg in final product. 
 
Only to be used as co-
monomer. (1) 
474 43600 0004080-31-3 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride yes no no 0,3    
475 19110 0004098-71-9 1-isocyanato-3-isocyanatomethyl-3,5,5-
trimethylcyclohexane no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
476 16570 0004128-73-8 diphenylether-4,4'-diisocyanate no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
477 46720 0004130-42-1 2,6-di-tert-butyl-4-ethylphenol yes no yes 4,8   (1) 
478 60180 0004191-73-5 4-hydroxybenzoic acid, isopropyl ester yes no no     
479 12970 0004196-95-6 azelaic anhydride no yes no     
480 46790 0004221-80-1 3,5-di-tert-butyl-4-hydroxybenzoic acid, 
2,4-di-tert-butylphenyl ester yes no no     
481 13060 0004422-95-1 1,3,5-benzenetricarboxylic acid 
trichloride no yes no 0,05  SML expressed as 1,3,5-
benzenetricarboxylic acid (1) 
482 21100 0004655-34-9 methacrylic acid, isopropyl ester no yes no  (23)   
483 68860 0004724-48-5 n-octylphosphonic acid yes no no 0,05    
484 13395 0004767-03-7 2,2-bis(hydroxymethyl)propionic acid no yes no 0,05   (1)  
EN 57   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
13560 485 
15700 0005124-30-1 dicyclohexylmethane-4,4'-diisocyanate  no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
486 54005 0005136-44-7 ethylene-N-palmitamide -N'-stearamide yes no no     
487 45640 0005232-99-5 2-cyano-3,3-diphenylacrylic acid, ethyl 
ester yes no no 0,05    
488 53440 0005518-18-3 N,N'-ethylenebispalmitamide yes no no     
489 41040 0005743-36-2 calcium butyrate yes no no     
490 16600 0005873-54-1 diphenylmethane-2,4'-diisocyanate  no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
491 82720 0006182-11-2 1,2-propyleneglycol distearate yes no no     
492 45650 0006197-30-4 2-cyano-3,3-diphenylacrylic acid, 2-
ethylhexyl ester yes no no 0,05    
493 39200 0006200-40-4 bis(2-hydroxyethyl)-2-hydroxypropyl-3-
(dodecyloxy)methylammonium chloride yes no no 1,8    
494 62140 0006303-21-5 hypophosphorous acid yes no no     
495 35160 0006642-31-5 6-amino-1,3-dimethyluracil yes no no 5    
496 71680 0006683-19-8 pentaerythritol tetrakis[3-(3,5-di-tert-
butyl-4-hydroxyphenyl)-propionate] yes no no     
497 95020 0006846-50-0 2,2,4-trimethyl-1,3-pentanediol 
diisobutyrate yes no no 5  Only to be used in single-use 
gloves  
498 16210 0006864-37-5 3,3'-dimethyl-4,4'-
diaminodicyclohexylmethane no yes no 0,05  Only to be used in 
polyamides (5) 
19965 499 
65020 0006915-15-7 malic acid yes yes no   In case of use as a monomer 
only to be used as a co-
monomer in aliphatic 
polyesters up to maximum 
level of 1 % on a molar basis  
500 38560 0007128-64-5 2,5-bis(5-tert-butyl-2-
benzoxazolyl)thiophene yes no yes 0,6     
EN 58   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
501 34480 — aluminium fibers, flakes and powders yes no no     
502 22778 0007456-68-0 4,4'-oxybis(benzenesulphonyl azide) no yes no 0,05   (1) 
503 46080 0007585-39-9 β-dextrin yes no no     
504 86240 0007631-86-9 silicon dioxide yes no no   For synthetic amorphous 
silicon dioxide: primary 
particles of 1 - 100 nm which 
are aggregated to a size of 0,1 
– 1 µm which may form 
agglomerates within the size 
distribution of 0.3µm to the 
mm size.  
505 86480 0007631-90-5 sodium bisulphite yes no no  (19)   
506 86920 0007632-00-0 sodium nitrite yes no no 0,6    
507 59990 0007647-01-0 hydrochloric acid yes no no     
508 86560 0007647-15-6 sodium bromide yes no no     
23170 509 
72640 0007664-38-2 phosphoric acid yes yes no     
12789 510 
35320 0007664-41-7 ammonia yes yes no     
511 91920 0007664-93-9 sulphuric acid yes no no     
512 81680 0007681-11-0 potassium iodide yes no no  (6)   
513 86800 0007681-82-5 sodium iodide yes no no  (6)   
514 91840 0007704-34-9 sulphur yes no no     
26360 515 
95855 0007732-18-5 water yes yes no   In compliance with Directive 
98/83/EC20  
                                                 
20 OJ L 330, 5.12.1998, p. 32   
EN 59   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
516 86960 0007757-83-7 sodium sulphite yes no no  (19)   
517 81520 0007758-02-3 potassium bromide yes no no     
518 35845 0007771-44-0 arachidonic acid yes no no     
519 87120 0007772-98-7 sodium thiosulphate yes no no  (19)   
520 65120 0007773-01-5 manganese chloride yes no no     
521 58320 0007782-42-5 graphite yes no no     
522 14530 0007782-50-5 chlorine no yes no     
523 45195 0007787-70-4 copper bromide yes no no     
524 24520 0008001-22-7 soybean oil no yes no     
525 62640 0008001-39-6 japan wax yes no no     
526 43440 0008001-75-0 ceresin yes no no     
14411 527 
42880 0008001-79-4 castor oil yes yes no     
528 63760 0008002-43-5 lecithin yes no no     
529 67850 0008002-53-7 montan wax yes no no     
530 41760 0008006-44-8 candelilla wax yes no no     
531 36880 0008012-89-3 beeswax yes no no     
532 88640 0008013-07-8 soybean oil, epoxidised yes no no 60 
30(*) (32) (*) In the case of PVC 
gaskets used to seal glass 
jars containing infant 
formulae and follow-on 
formulae as defined by 
Directive 2006/141/EC or 
processed cereal-based 
foods and baby foods for 
infants and young children 
as defined by Directive 
2006/125/EC, the SML is 
lowered to 30 mg/kg. 
   
EN 60   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
Oxirane < 8 %, iodine 
number < 6. 
533 42720 0008015-86-9 carnauba wax yes no no     
534 80720 0008017-16-1 polyphosphoric acids yes no no     
24100 
24130 
24190 535 
83840 0008050-09-7 rosin yes yes no     
536 84320 0008050-15-5 rosin, hydrogenated, ester with methanol yes no no     
537 84080 0008050-26-8 rosin, ester with pentaerythritol yes no no     
538 84000 0008050-31-5 rosin, ester with glycerol yes no no     
539 24160 0008052-10-6 rosin tall oil no yes no     
540 63940 0008062-15-5 lignosulphonic acid yes no no 0,24  Only to be used as dispersant 
for plastics dispersions  
541 58480 0009000-01-5 gum arabic yes no no     
542 42640 0009000-11-7 carboxymethylcellulose yes no no     
543 45920 0009000-16-2 dammar yes no no     
544 58400 0009000-30-0 guar gum yes no no     
545 93680 0009000-65-1 tragacanth gum yes no no     
546 71440 0009000-69-5 pectin yes no no     
547 55440 0009000-70-8 gelatin yes no no     
548 42800 0009000-71-9 casein yes no no     
549 80000 0009002-88-4 polyethylene wax yes no no     
550 81060 0009003-07-0 polypropylene wax yes no no     
551 79920 0009003-11-6 
0106392-12-5 poly(ethylene propylene) glycol yes no no      
EN 61   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
552 81500 0009003-39-8 polyvinylpyrrolidone yes no no   The substance shall meet the 
purity criteria as laid down in 
Commission Directive 
2008/84/EC21  
14500 553 
43280 0009004-34-6 cellulose yes yes no     
554 43300 0009004-36-8 cellulose acetate butyrate yes no no     
555 53280 0009004-57-3 ethylcellulose yes no no     
556 54260 0009004-58-4 ethylhydroxyethylcellulose yes no no     
557 66640 0009004-59-5 methylethylcellulose yes no no     
558 60560 0009004-62-0 hydroxyethylcellulose yes no no     
559 61680 0009004-64-2 hydroxypropylcellulose yes no no     
560 66700 0009004-65-3 methylhydroxypropylcellulose yes no no     
561 66240 0009004-67-5 methylcellulose yes no no     
562 22450 0009004-70-0 nitrocellulose no yes no     
563 78320 0009004-97-1 polyethyleneglycol monoricinoleate yes no yes 42    
24540 564 
88800 0009005-25-8 starch, edible yes yes no     
565 61120 0009005-27-0 hydroxyethyl starch yes no no     
566 33350 0009005-32-7 alginic acid yes no no     
567 82080 0009005-37-2 1,2-propyleneglycol alginate yes no no     
568 79040 0009005-64-5 polyethyleneglycol sorbitan monolaurate yes no no     
569 79120 0009005-65-6 polyethyleneglycol sorbitan monooleate yes no no     
570 79200 0009005-66-7 polyethyleneglycol sorbitan yes no no     
                                                 
21 OJ L 253, 20.9.2008, p. 1.  
EN 62   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
monopalmitate 
571 79280 0009005-67-8 polyethyleneglycol sorbitan monostearate yes no no     
572 79360 0009005-70-3 polyethyleneglycol sorbitan trioleate yes no no     
573 79440 0009005-71-4 polyethyleneglycol sorbitan tristearate yes no no     
24250 574 
84560 0009006-04-6 rubber, natural yes yes no     
575 76721 0063148-62-9 polydimethylsiloxane (Mw > 6800 Da) yes no no   Viscosity at 25 °C not less 
than 100 cSt (100 x 10-6 m2/s)  
576 60880 0009032-42-2 hydroxyethylmethylcellulose yes no no     
577 62280 0009044-17-1 isobutylene-butene copolymer yes no no     
578 79600 0009046-01-9 polyethyleneglycol tridecyl ether 
phosphate yes no no 5  For materials and articles 
intended for contact with 
aqueous foods only. 
 
Polyethyleneglycol (EO ≤ 11) 
tridecyl ether phosphate 
(mono-and dialkyl ester) with 
a maximum 10 % content of 
polyethyleneglycol (EO ≤ 11) 
tridecylether.  
579 61800 0009049-76-7 hydroxypropyl starch yes no no     
580 46070 0010016-20-3 α-dextrin yes no no     
581 36800 0010022-31-8 barium nitrate yes no no     
582 50240 0010039-33-5 di-n-octyltin bis(2-ethylhexyl maleate) yes no no  (10)   
583 40400 0010043-11-5 boron nitride yes no no  (16)   
13620 584 
40320 0010043-35-3 boric acid yes yes no  (16)   
585 41120 0010043-52-4 calcium chloride yes no no     
586 65280 0010043-84-2 manganese hypophosphite yes no no      
EN 63   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
587 68400 0010094-45-8 octadecylerucamide yes no yes 5    
588 64320 0010377-51-2 lithium iodide yes no no  (6)   
589 52645 0010436-08-5 cis-11-eicosenamide yes no no     
590 21370 0010595-80-9 methacrylic acid, 2-sulphoethyl ester no yes no ND   (1) 
591 36160 0010605-09-1 ascorbyl stearate yes no no     
592 34690 0011097-59-9 aluminium magnesium carbonate 
hydroxide yes no no     
593 44960 0011104-61-3 cobalt oxide yes no no     
594 65360 0011129-60-5 manganese oxide yes no no     
595 19510 0011132-73-3 lignocellulose no yes no     
596 95935 0011138-66-2 xanthan gum yes no no     
597 67120 0012001-26-2 mica yes no no     
598 41600 0012004-14-7 
0037293-22-4 calcium sulphoaluminate yes no no     
599 36840 0012007-55-5 barium tetraborate yes no no  (16)   
600 60030 0012072-90-1 hydromagnesite yes no no     
601 35440 0012124-97-9 ammonium bromide yes no no     
602 70240 0012198-93-5 ozokerite yes no no     
603 83460 0012269-78-2 pyrophyllite yes no no     
604 60080 0012304-65-3 hydrotalcite yes no no     
605 11005 0012542-30-2 acrylic acid, dicyclopentenyl ester no yes no 0,05   (1) 
606 65200 0012626-88-9 manganese hydroxide yes no no     
607 62245 0012751-22-3 iron phosphide yes no no   Only to be used in PET 
polymers and copolymers  
608 40800 0013003-12-8 4,4'-butylidene-bis(6-tert-butyl-3-
methylphenyl-ditridecyl phosphite) yes no yes 6     
EN 64   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
609 83455 0013445-56-2 pyrophosphorous acid yes no no     
610 93440 0013463-67-7 titanium dioxide yes no no     
611 35120 0013560-49-1 3-aminocrotonic ac id, diester with thiobis 
(2-hydroxyethyl) ether yes no no     
612 16694 0013811-50-2 N,N'-divinyl-2-imidazolidinone no yes no 0,05   (10) 
613 95905 0013983-17-0 wollastonite yes no no     
614 45560 0014464-46-1 cristobalite yes no no     
615 92080 0014807-96-6 talc yes no no     
616 83470 0014808-60-7 quartz yes no no     
617 10660 0015214-89-8 2-acrylamido-2-methylpropanesulphonic 
acid no yes no 0,05    
618 51040 0015535-79-2 di-n-octyltin mercaptoacetate yes no no  (10)   
619 50320 0015571-58-1 di-n-octyltin bis(2-ethylhexyl 
mercaptoacetate) yes no no  (10)   
620 50720 0015571-60-5 di-n-octyltin dimaleate yes no no  (10)   
621 17110 0016219-75-3 5-ethylidenebicyclo[2,2,1]hept-2-ene no yes no 0,05   (9) 
622 69840 0016260-09-6 oleylpalmitamide yes no yes 5    
623 52640 0016389-88-1 dolomite yes no no     
624 18897 0016712-64-4 6-hydroxy-2-naphthalenecarboxylic acid no yes no 0,05    
625 36720 0017194-00-2 barium hydroxide yes no no     
626 57800 0018641-57-1 glycerol tribehenate yes no no     
627 59760 0019569-21-2 huntite yes no no     
628 96190 0020427-58-1 zinc hydroxide yes no no     
629 34560 0021645-51-2 aluminium hydroxide yes no no     
630 82240 0022788-19-8 1,2-propyleneglycol dilaurate yes no no     
631 59120 0023128-74-7 1,6-hexamethylene-bis(3-(3,5-di-tert- yes no yes 45     
EN 65   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
butyl-4-hydroxyphenyl)propionamide) 
632 52880 0023676-09-7 4-ethoxybenzoic acid, ethyl ester yes no no 3,6    
633 53200 0023949-66-8 2-ethoxy-2'-ethyloxanilide yes no yes 30    
634 25910 0024800-44-0 tripropyleneglycol no yes no     
635 40720 0025013-16-5 tert-butyl-4-hydroxyanisole yes no no 30    
636 31500 0025134-51-4 acrylic acid, acrylic acid, 2-ethylhexyl 
ester, copolymer yes no no 0,05 (22) SML expressed as acrylic 
acid, 2-ethylhexyl ester  
637 71635 0025151-96-6 pentaerythritol dioleate yes no no 0,05  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down  
23590 638 
76960 0025322-68-3 polyethyleneglycol yes yes no     
23651 639 
80800 0025322-69-4 polypropyleneglycol yes yes no     
640 54930 0025359-91-5 formaldehyde-1-naphthol, copolymer yes no no 0,05    
641 22331 0025513-64-8 mixture of (35-45 % w/w) 1,6-diamino-
2,2,4-trimethylhexane and (55-65 % 
w/w)1,6-diamino-2,4,4-trimethylhexane no yes no 0,05   (10) 
642 64990 0025736-61-2 maleic anhydride-styrene, copolymer, 
sodium salt yes no no   The fraction with molecular 
weight below 1 000 Da 
should not exceed 0,05 % (w/w)  
643 87760 0026266-57-9 sorbitan monopalmitate yes no no     
644 88080 0026266-58-0 sorbitan trioleate yes no no     
645 67760 0026401-86-5 mono-n-octyltin tris(isooctyl 
mercaptoacetate) yes no no  (11)   
646 50480 0026401-97-8 di-n-octyltin bis(isooctyl 
mercaptoacetate) yes no no  (10)    
EN 66   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
647 56720 0026402-23-3 glycerol monohexanoate yes no no     
648 56880 0026402-26-6 glycerol monooctanoate yes no no     
649 47210 0026427-07-6 dibutylthiostannoic acid polymer yes no no   Molecular unit = 
(C8H18S3Sn2)n (n = 1,5-2)  
650 49600 0026636-01-1 dimethyltin bis(isooctyl mercaptoacetate) yes no no  (9)   
651 88240 0026658-19-5 sorbitan tristearate yes no no     
652 38820 0026741-53-7 bis(2,4-di-tert-butylphenyl) 
pentaerythritol diphosphite yes no yes 0,6    
653 25270 0026747-90-0 2,4-toluene diisocyanate dimer no yes no  (17) 1 mg/kg in final product 
expressed as isocyanate 
moiety (10) 
654 88600 0026836-47-5 sorbitol monostearate yes no no     
655 25450 0026896-48-0 tricyclodecanedimethanol no yes no 0,05    
656 24760 0026914-43-2 styrenesuphonic acid no yes no 0,05    
657 67680 0027107-89-7 mono-n-octyltin tris(2-ethylhexyl 
mercaptoacetate) yes no no  (11)   
658 52000 0027176-87-0 dodecylbenzenesulphonic acid yes no no 30    
659 82800 0027194-74-7 1,2-propyleneglycol monolaurate yes no no     
660 47540 0027458-90-8 di-tert-dodecyl disulphide yes no yes 0,05    
661 95360 0027676-62-6 1,3,5-tris(3,5-di-tert-butyl-4-
hydroxybenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione yes no yes 5    
662 25927 0027955-94-8 1,1,1-tris(4-hydroxyphenol)ethane no yes no 0,005  Only to be used in 
polycarbonates (1) 
663 64150 0028290-79-1 linolenic acid yes no no     
664 95000 0028931-67-1 trimethylolpr opane trimethacrylate-
methyl methacrylate copolymer yes no no     
665 83120 0029013-28-3 1,2-propyleneglycol monopalmitate yes no no      
EN 67   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
666 87280 0029116-98-1 sorbitan dioleate yes no no     
667 55190 0029204-02-2 gadoleic acid yes no no     
668 80240 0029894-35-7 polyglycerol ricinoleate yes no no     
669 56610 0030233-64-8 glycerol monobehenate yes no no     
670 56800 0030899-62-8 glycerol monolaurate diacetate yes no no  (32)   
671 74240 0031570-04-4 phosphorous acid, tris(2,4-di-tert-
butylphenyl)ester yes no no     
672 76845 0031831-53-5 polyester of 1,4-butanediol with 
caprolactone yes no no  (29) 
(30) The fraction with molecular 
weight below 1 000 Da 
should not exceed 0,5 % 
(w/w)  
673 53670 0032509-66-3 ethylene glycol bis[3,3-bis(3-tert-butyl-4-
hydroxyphenyl)butyrate] yes no yes 6    
674 46480 0032647-67-9 dibenzylidene sorbitol yes no no     
675 38800 0032687-78-8 N,N'-bis(3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionyl)hydrazide yes no yes 15    
676 50400 0033568-99-9 di-n-octyltin bis(isooctyl maleate) yes no no  (10)   
677 82560 0033587-20-1 1,2-propyleneglycol dipalmitate yes no no     
678 59200 0035074-77-2 1,6-hexamethylene-bis(3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate) yes no yes 6    
679 39060 0035958-30-6 1,1-bis(2-hydroxy-3,5-di-tert-
butylphenyl)ethane yes no yes 5    
680 94400 0036443-68-2 triethyleneglycol bis[3-(3-tert-butyl-4-
hydroxy-5-methylphenyl) propionate] yes no no 9    
681 18310 0036653-82-4 1-hexadecanol no yes no     
682 53270 0037205-99-5 ethylcarboxymethylcellulose yes no no     
683 66200 0037206-01-2 methylcarboxymethylcellulose yes no no     
684 68125 0037244-96-5 nepheline syenite yes no no      
EN 68   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
685 85950 0037296-97-2 silicic acid, magnesium-sodium-fluoride 
salt yes no no 0,15  SML expressed as fluoride. 
 
Only to be used in layers of 
multi-layer materials not 
coming into direct contact 
with food.  
686 61390 0037353-59-6 hydroxymethylcellulose yes no no     
13530 687 
13614 0038103-06-9 2,2-bis(4-hydroxyphenyl)propane 
bis(phthalic anhydride) no yes no 0,05    
688 92560 0038613-77-3 tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-
biphenylylene diphosphonite yes no yes 18    
689 95280 0040601-76-1 1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-
dimethylbenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione yes no yes 6    
690 92880 0041484-35-9 thiodiethanol bis(3-(3,5-di-tert-butyl-4-
hydroxy phenyl) propionate) yes no yes 2,4    
691 13600 0047465-97-4 3,3-bis(3-methyl-4-hydroxyphenyl)2-
indolinone no yes no 1,8    
692 52320 0052047-59-3 2-(4-dodecylphenyl)indole yes no yes 0,06    
693 88160 0054140-20-4 sorbitan tripalmitate yes no no     
694 21400 0054276-35-6 methacrylic acid, sulphopropyl ester no yes no 0,05   (1) 
695 67520 0054849-38-6 monomethyltin tris(isooctyl 
mercaptoacetate) yes no no  (9)   
696 92205 0057569-40-1 terephthalic ac id, diester with 2,2'-
methylenebis(4-methyl-6-tert-
butylphenol) yes no no     
697 67515 0057583-34-3 monomethyltin tris(ethylhexyl 
mercaptoacetate) yes no no  (9)   
698 49595 0057583-35-4 dimethyltin bis(ethylhexyl 
mercaptoacetate) yes no no  (9)   
699 90720 0058446-52-9 stearoylbenzoylmethane yes no no      
EN 69   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
700 31520 0061167-58-6 acrylic acid, 2-tert-butyl-6-(3-tert-butyl-
2-hydroxy-5-methylbenzyl)-4-
methylphenyl ester yes no yes 6    
701 40160 0061269-61-2 N,N'-bis(2,2,6,6-tetramethyl-4-
piperidyl)hexamethylenediamine-1,2-
dibromoethane, copolymer yes no no 2,4    
702 87920 0061752-68-9 sorbitan tetrastearate yes no no     
703 17170 0061788-47-4 fatty acids, coco no yes no     
704 77600 0061788-85-0 polyethyleneglycol ester of hydrogenated 
castor oil yes no no     
10599/ 
90A 705 
10599/ 
91 0061788-89-4 acids, fatty, unsat urated (C18), dimers, 
non hydrogenated, distilled and non-
distilled no yes no  (18)  (1) 
706 17230 0061790-12-3 fatty acids, tall oil no yes no     
707 46375 0061790-53-2 diatomaceous earth yes no no     
708 77520 0061791-12-6 polyethyleneglycol ester of castor oil yes no no 42    
709 87520 0062568-11-0 sorbitan monobehenate yes no no     
710 38700 0063397-60-4 bis(2-carbobutoxyethyl)tin-bis(isooctyl 
mercaptoacetate) yes no yes 18    
711 42000 0063438-80-2 (2-carbobutoxyethyl)tin-tris(isooctyl 
mercaptoacetate) yes no yes 30    
712 42960 0064147-40-6 castor oil, dehydrated yes no no     
713 43480 0064365-11-3 charcoal, activated yes no no   Only for use in PET at 
maximum 10 mg/kg of 
polymer. 
 
Same purity requirements as 
for Vegetable Carbon (E 153)   
EN 70   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
set out by Commission 
Directive 95/45/EC22 with 
exception of ash content 
which can be up to 10 % 
(w/w). 
714 84400 0064365-17-9 rosin, hydrogenated, ester with 
pentaerythritol yes no no     
715 46880 0065140-91-2 3,5-di-tert-butyl-4-
hydroxybenzylphosphonic acid, 
monoethyl ester, calcium salt yes no no 6    
716 60800 0065447-77-0 1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-
tetramethyl piperidi ne-succinic acid, 
dimethyl ester, copolymer yes no no 30    
717 84210 0065997-06-0 rosin, hydrogenated yes no no     
718 84240 0065997-13-9 rosin, hydrogenated, ester with glycerol yes no no     
719 65920 0066822-60-4 N-methacryloyloxyethyl-N,N-dimethyl-
N-carboxymethylammonium chloride, 
sodium salt -octadecyl methacrylate-ethyl 
methacrylate-cyclohexyl methacrylate-N-
vinyl-2-pyrrolidone, copolymers yes no no     
720 67360 0067649-65-4 mono-n-dodecyltin tris(isooctyl 
mercaptoacetate) yes no no  (25)   
721 46800 0067845-93-6 3,5-di-tert-butyl-4-hydroxybenzoic acid, 
hexadecyl ester yes no no     
722 17200 0068308-53-2 fatty acids, soya no yes no     
723 88880 0068412-29-3 starch, hydrolysed yes no no     
724 24903 0068425-17-2 syrups, hydrolysed starch, hydrogenated no yes no   In compliance with the purity 
criteria for maltitol syrup E 
965(ii) as laid down in  
                                                 
22 OJ L 226, 22.9.1995, p. 1.   
EN 71   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
Commission Directive 
2008/60/EC23  
725 77895 0068439-49-6 polyethyleneglycol (EO = 2-
6) monoalkyl (C16-C18) ether yes no no 0,05  The composition of this 
mixture is as follows: 
— polyethyleneglycol (E0 = 
2-6)monoalkyl (C 16-C18) 
ether (approximately 
28 %) 
— fatty alcohols (C 16-C18) 
(approximately 48 %) 
— ethyleneglycol monoalkyl 
(C16-C18) ether 
(approximately 24 %)  
726 83599 0068442-12-6 reaction products of oleic acid, 2-
mercaptoethyl ester, with 
dichlorodimethyltin, sodium sulphide and 
trichloromethyltin yes no yes  (9)   
727 43360 0068442-85-3 cellulose, regenerated yes no no     
728 75100 0068515-48-0 
0028553-12-0 phthalic acid, diesters with primary, 
saturated C8-C10 branched alcohols, 
more than 60 % C9 yes no no  (26) 
(32) Only to be used as: 
(a) plasticizer in repeated use 
materials and articles;  
(b) plasticizer in single-use 
materials and articles 
contacting non-fatty foods 
except for infant formulae 
and follow-on formulae as 
defined by Directive 
2006/141/EC or processed 
cereal-based foods and 
baby foods for infants and 
young children as defined 
by Directive (7) 
                                                                                                                                                                                                                                                    
23 OJ L 158, 18.6.2008, p.17–40.   
EN 72   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
2006/125/EC; 
(c) technical support agent in 
concentrations up to 0,1 % 
in the final product. 
729 75105 0068515-49-1 
0026761-40-0 phthalic acid, diesters with primary, 
saturated C9-C11 alcohols more than 
90 % C10 yes no no  (26) 
(32) Only to be used as:  
(a) plasticizer in repeated use 
materials and articles; 
(b) plasticizer in single-use 
materials and articles 
contacting non-fatty foods 
except for infant formulae 
and follow-on formulae as 
defined by Directive 
2006/141/EC or processed 
cereal-based foods and 
baby foods for infants and 
young children as defined 
by Directive 
2006/125/EC; 
(c) technical support agent in 
concentrations up to 0,1 % 
in the final product. (7) 
730 66930 0068554-70-1 methylsilsesquioxane yes no no   Residual monomer in 
methylsilsesquioxane: < 1 mg 
methyltrimethoxysilane/kg of 
methylsilsesquioxane  
731 18220 0068564-88-5 N-heptylaminoundecanoic acid no yes no 0,05   (2) 
732 45450 0068610-51-5 p-cresol-dicyclopentadiene-isobutylene, 
copolymer  yes no yes 5    
10599/ 
92A 733 
10599/ 
93 0068783-41-5 acids, fatty, unsat urated (C18), dimers, 
hydrogenated, distilled and non-distilled no yes no  (18)  (1) 
734 46380 0068855-54-9 diatomaceous earth, s oda ash flux- yes no no      
EN 73   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
calcined 
735 40120 0068951-50-8 bis(polyethyleneglycol)hydroxymethylph
osphonate yes no no 0,6    
736 50960 0069226-44-4 di-n-octyltin ethyleneglycol 
bis(mercaptoacetate) yes no no  (10)   
737 77370 0070142-34-6 polyethyleneglycol-30 
dipolyhydroxystearate yes no no     
738 60320 0070321-86-7 2-[2-hydroxy-3,5-bis(1,1-
dimethylbenzyl)phenyl]benzotriazole yes no yes 1,5    
739 70000 0070331-94-1 2,2'-oxamidobis[ethyl-3-(3,5-di-tert-
butyl-4-hydroxyphenyl)-propionate] yes no no     
740 81200 0071878-19-8 poly[6-[(1,1,3,3-
tetramethylbutyl)amino]-1,3,5-triazine-
2,4-diyl]-[(2,2,6,6-tetramethyl-4-
piperidyl)-imino]hexamethylene[(2,2,6,6-
tetramethyl-4-piperidyl) imino] yes no yes 3    
24070 741 
83610 0073138-82-6 resin acids and rosin acids yes yes no     
742 92700 0078301-43-6 2,2,4,4-tetramethyl-20-(2,3-
epoxypropyl)-7-oxa-3,20-diazadispiro-
[5.1.11.2]-heneicosan-21-one, polymer yes no yes 5    
743 38950 0079072-96-1 bis(4-ethylbenzylidene)sorbitol yes no no     
744 18888 0080181-31-3 3-hydroxybutanoic acid-3-
hydroxypentanoic acid, copolymer no yes no   The substance is used as 
product obtained by bacterial 
fermentation. In compliance 
with the specifications 
mentioned in the table 4 of 
Annex I  
745 68145 0080410-33-9 2,2',2"-nitrilo(triethyl tris(3,3',5,5'-tetra-
tert-butyl-1,1'-bi-phenyl-2,2'-
diyl)phosphite) yes no yes 5  SML expressed as sum of 
phosphite and phosphate  
746 38810 0080693-00-1 bis(2,6-di-tert-butyl-4- yes no yes 5  SML expressed as sum of   
EN 74   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
methylphenyl)pentaerythritol diphosphite phosphite and phosphate 
747 47600 0084030-61-5 di-n-dodecyltin bis(isooctyl 
mercaptoacetate) yes no yes  (25)   
748 12765 0084434-12-8 N-(2-aminoethyl)- β-alanine, sodium salt no yes no 0,05    
749 66360 0085209-91-2 2,2'-methylene bis(4,6-di-tert-
butylphenyl) sodium phosphate yes no yes 5    
750 66350 0085209-93-4 2,2'-methylenebis(4,6-di-tert-
butylphenyl) lithium phosphate yes no no 5    
751 81515 0087189-25-1 poly(zinc glycerolate) yes no no     
752 39890 0087826-41-
30069158-41-
40054686-97-
40081541-12-
0 bis(methylbenzylidene)sorbitol yes no no     
753 62800 0092704-41-1 kaolin, calcined yes no no     
754 56020 0099880-64-5 glycerol dibehenate yes no no     
755 21765 0106246-33-7 4,4'-methylenebis(3-chloro-2,6-
diethylaniline) no yes no 0,05   (1) 
756 40020 0110553-27-0 2,4-bis(octylthiomethyl)-6 -methylphenol yes no yes  (24)   
757 95725 0110638-71-6 vermiculite, reac tion product with citric 
acid, lithium salt yes no no     
758 38940 0110675-26-8 2,4-bis(dodecylthiomethyl)-6-
methylphenol yes no yes  (24)   
759 54300 0118337-09-0 2,2'-ethylidenebis(4,6-di-tert-
butylphenyl) fluorophosphonite yes no yes 6    
760 83595 0119345-01-6 reaction product of di-tert-
butylphosphonite with biphenyl, obtained 
by condensation of 2,4-di-tert-
butylphenol with Frie del Craft reaction 
product of phosphorous trichloride and 
biphenyl yes no no 18  Composition: 
— 4,4'-biphenylene-bis[0,0-
bis(2,4-di-tert-
butylphenyl)phosphonite] 
(CAS No 0038613-77-3) 
(36-46 % w/w (*))   
EN 75   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
— 4,3'-biphenylene-bis[0,0-
bis(2,4-di-tert-
butylphenyl)phosphonite] 
(CAS No 0118421-00-4) 
(17-23 % w/w (*)) 
— 3,3'-biphenylene-bis[0,0-
bis(2,4-di-tert-
butylphenyl)phosphonite] 
(CAS No 0118421-01-5) 
(1-5 % w/w (*)) 
— 4-biphenylene-0,0-bis(2,4-
di-tert-
butylphenyl)phosphonite 
(CAS No 0091362-37-7) 
(11-19 % w/w (*)) 
— tris(2,4-di-tert-
butylphenyl)phosphite 
(CAS No 0031570-04-4) 
(9-18 % w/w (*)) 
— 4,4'-biphenylene-0,0-
bis(2,4-di-tert-
butylphenyl)phosphonate-
0,0-bis(2,4-di-tert-
butylphenyl)phosphonite 
(CAS No 0112949-97-0) 
(< 5 % w/w (*)) 
(*) Quantity of substance 
used /quantity of 
formulation 
Other specifications: 
— Phosphor content of min. 
5,4 % to max. 5,9 % 
— Acid value of max. 10 mg 
KOH per gram 
— Melt range of 85-110 °C  
EN 76   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
761 92930 0120218-34-0 thiodiethanolbis(5-methoxycarbonyl-2,6-
dimethyl-1,4-dihydropyridine-3-
carboxylate) yes no no 6    
762 31530 0123968-25-2 acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-
di-tert-pentyl-2-
hydroxyphenyl)ethyl)phenyl ester yes no yes 5    
763 39925 0129228-21-3 3,3-bis(methoxymethyl)-2,5-
dimethylhexane yes no yes 0,05    
764 13317 0132459-54-2 N,N'-bis[4-(ethoxycarbonyl)phenyl]-
1,4,5,8-naphthalenetetracarboxydiimide no yes no 0,05  Purity > 98,1 % (w/w). 
Only to be used as co-
monomer (max 4 %) for 
polyesters (PET, PBT).  
765 49485 0134701-20-5 2,4-dimethyl-6-(1-
methylpentadecyl)phenol yes no yes 1    
766 38879 0135861-56-2 bis(3,4-dimethylbenzylidene)sorbitol yes no no     
767 38510 0136504-96-6 1,2-bis(3-aminopropyl)ethylenediamine, 
polymer with N-butyl-2,2,6,6-
tetramethyl-4-piperidinamine and 2,4,6-
trichloro-1,3,5-triazine yes no no 5    
768 34850 0143925-92-2 amines, bis(hydrogenated tallow alkyl) 
oxidised yes no no   Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid down. 
 
Only to be used in: (a) 
polyolefins at 0,1% (w/w) 
concentration and in (b) PET 
at 0,25% (w/w) 
concentration. (1) 
769 74010 0145650-60-8 phosphorous acid, bis(2,4-di-tert-butyl-6-
methylphenyl) ethyl ester yes no yes 5  SML expressed as sum of 
phosphite and phosphate  
770 51700 0147315-50-2 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-
(hexyloxy)phenol yes no no 0,05    
771 34650 0151841-65-5 aluminium hydroxybis [2,2'-methylenebis yes no no 5     
EN 77   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
(4,6-di-tert-butylphenyl) phosphate] 
772 47500 0153250-52-3 N,N'-dicyclohexyl-2,6-naphthalene 
dicarboxamide yes no no 5    
773 38840 0154862-43-8 bis(2,4-dicumylphenyl)pentaerythritol-
diphosphite yes no yes 5  SML expressed as sum of the 
substance itself, its oxidised 
form bis(2,4-
dicumylphenyl)pentaerythrito
l-phosphate and its hydrolysis 
product (2,4-dicumylphenol)  
774 95270 0161717-32-4 2,4,6-tris(tert-butyl)phenyl-2-butyl-2-
ethyl-1,3-propanediol phosphite yes no yes 2  SML expressed as sum of 
phosphite, phosphate and the 
hydrolysis product = TTBP  
775 45705 0166412-78-8 1,2-cyclohexanedicarboxylic acid, 
diisononyl ester yes no no  (32)   
776 76723 0167883-16-1 polydimethylsiloxane, 3-aminopropyl 
terminated, polymer with 
dicyclohexylmethane- 4,4’-diisocyanate yes no no   The fraction with molecular 
weight below 1 000 Da 
should not exceed 1,5 % 
(w/w)  
777 31542 0174254-23-0 acrylic acid, methyl ester, telomer with 1-
dodecanethiol, C16-C18 alkyl esters yes no no   0,5% in final product (1) 
778 71670 0178671-58-4 pentaerythritol tetrakis (2-cyano-3,3-
diphenylacrylate) yes no yes 0,05    
779 39815 0182121-12-6 9,9-bis(methoxymethyl)fluorene yes no yes 0,05   (1) 
780 81220 0192268-64-7 poly-[[6-[N-(2,2,6,6-tetramethyl-4-
piperidinyl)-n-butylamino]-1,3,5-triazine-
2,4-diyl][(2,2,6,6-tetramethyl-4-
piperidinyl)imino]-1,6-
hexanediyl[(2,2,6,6-tetramethyl-4-
piperidinyl)imino]]- α-[N,N,N',N'-
tetrabutyl-N"-(2,2,6,6-tetramethyl-4-
piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-
4-piperidinylamino)-hexyl]-[1,3,5-
triazine-2,4,6-triamine]- ω-N,N,N',N'-
tetrabutyl-1,3,5-triazine-2,4-diamine] yes no no 5     
EN 78   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
781 95265 0227099-60-7 1,3,5-tris(4-benzoylphenyl) benzene yes no no 0,05    
782 76725 0661476-41-1 polydimethylsiloxane, 3-aminopropyl 
terminated, polymer w ith 1-isocyanato-3-
isocyanatomethyl-3,5,5-
trimethylcyclohexane yes no no   The fraction with molecular 
weight below 1 000 Da 
should not exceed 1 % (w/w)  
783 55910 0736150-63-3 glycerides, castor-oil mono-, 
hydrogenated, acetates yes no no  (32)   
784 95420 0745070-61-5 1,3,5-tris (2,2-
dimethylpropanamido)benzene yes no no 0,05    
785 24910 0000100-21-0 terephthalic acid no yes no  (28)   
786 14627 0000117-21-5 3-chlorophthalic anhydride no yes no 0,05  SML expressed as 3-
chlorophthalic acid  
787 14628 0000118-45-6 4-chlorophthalic anhydride no yes no 0,05  SML expressed as 4-
chlorophthalic acid  
788 21498 0002530-85-0 [3-
(methacryloxy)propyl]trimethoxysilane no yes no 0,05  Only to be used as a surface 
treatment agent of inorganic 
fillers (1) 
(11) 
789 60027 — hydrogenated homopolymers and/or 
copolymers made of 1-hexene 
and/or 1-octene and/or 1-decene and/or 1-
dodecene and/or 1- 
tetradecene (Mw: 440-12000) yes no no   Average molecular weight 
not less than 440 Da. 
 
Viscosity at 100 °C not less 
than 3,8 cSt (3,8 x 10-6 m2/s). (2) 
790 80480 0090751-07-8 
0082451-48-7 poly(6-morpholino-1,3,5-triazine-2,4-
diyl)-[(2,2,6,6-tetramethyl-4-
piperidyl)imino)] hexa-methylene-
[(2,2,6,6-tetramethyl-4-piperidyl)imino)] yes no no 5  Average molecular weight 
not less than 2400 Da. 
 
Residual content of 
morpholine ≤30 mg/kg, of 
N,N'-bis(2,2,6,6-
tetramethylpiperidin-4-
yl)hexane-1,6-diamine 
<15000 mg/kg, and of 2,4-
dichloro-6-morpholino-1,3,5-
triazine ≤20 mg/kg. (16) 
791 92470 0106990-43-6 N,N',N'',N''-tetrakis(4,6-bis(N-butyl-(N- yes no no 0,05     
EN 79   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
methyl-2,2,6,6-tetramethylpiperidin-4-
yl)amino)triazin-2-yl)-4,7-diazadecane-
1,10-diamine 
792 92475 0203255-81-6 3,3',5,5'-tetrakis(tert-butyl)-2,2'-
dihydroxybiphenyl, cyclic ester with [3-
(3-tert-butyl-4-hydroxy-5-
methylphenyl)propyl]oxyphosphonous 
acid yes no yes 5  SML expressed as the sum of 
phosphite and phosphate form 
of the substance and the 
hydrolysis products  
793 94000 0000102-71-6 triethanolamine yes no no 0,05  SML expressed as the sum of 
triethanolamine and the 
hydrochloride adduct expressed as triethanolamine  
794 18117 0000079-14-1 glycolic acid no yes no   For indirect food contact 
only, behind a PET layer  
795 40155 0124172-53-8 N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)-
N,N'-diformylhexamethylenediamine yes no no 0,05   (2) 
(12) 
796 72141 0018600-59-4 2,2'-(1,4-phenylene)bis[4H-3,1-
benzoxazin-4-one] yes no yes 0,05  SML including the sum of its 
hydrolysis products  
797 76807 0007328-26-5 polyester of adipic acid with 1,3-
butanediol, 1,2-propanediol and 2-ethyl-
1-hexanol yes no yes  (31) 
(32)   
798 92200 0006422-86-2 terephthalic acid, bis(2-ethylhexyl)ester yes no no 60 (32)   
799 77708 — polyethyleneglycol (EO = 1-50) ethers of 
linear and branched primary (C8 - C22) 
alcohols yes no no 1,8  In compliance with the purity 
criteria for ethylene oxide as 
laid down in Directive 
2008/84/EC laying down 
specific purity criteria on 
food additives other than 
colours and sweeteners (OJ L 
253, 20.9.2008, p. 1–175)  
800 94425 0000867-13-0 triethyl phosphonoacetate yes no no   Only for use in PET  
801 30607 — acids, C 2-C24, aliphatic, linear, 
monocarboxylic, from natural oils and 
fats, lithium salt yes no no      
EN 80   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
802 33105 0146340-15-0 alcohols, C12-14 secondary, β-(2-
hydroxyethoxy), ethoxylated yes no no 5   (12) 
803 33535 0152261-33-1 α-alkenes(C20-C24) copolymer with 
maleic anhydride, reaction product with 
4-amino-2,2,6,6-tetramethylpiperidine yes no no   Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down. 
 
Not to be used in contact with 
alcoholic foods. (13) 
804 80510 1010121-89-7 poly(3-nonyl-1,1-dioxo-1-thiopropane-
1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process 
mixture with x=1 and/  or 5, neutralised 
with dodecylbenzenesulfonic acid yes no no   Only to be used as polymer 
production aid in polyethylene (PE), 
polypropylene (PP) and 
polystyrene (PS)  
805 93450 — titanium dioxide, coated with a 
copolymer of n-octyltrichlorosilane and 
[aminotris(methylenephosphonic acid), 
penta sodium salt] yes no no   The content of the surface 
treatment copol ymer of the 
coated titanium dioxide is less 
than 1% w/w  
806 14876 0001076-97-7 1,4-cyclohexanedicarboxylic acid no yes no 5  Only to be used for 
manufacture of polyesters  
807 93485 — titanium nitride, nanoparticles yes no no   No migration of titanium 
nitride nanoparticles. 
 
Only to be used in PET 
bottles up to 20 mg/kg.  
 
In the PET, the agglomerates 
have a diameter of 100 – 500 
nm consisting of primary 
titanium nitride nanoparticles; 
primary particles have a 
diameter of approximately 20 
nm.  
808 38550 0882073-43-0 bis(4-propylbenzylidene)propylsorbitol yes no no 5  SML including the sum of its 
hydrolysis products  
809 49080 0852282-89-4 N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3- yes no yes 0,05  Only for use in PET (6)  
EN 81   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
tetramethylbutyl)phenoxy]-1H-
benzo[de]isoquinolin-1,3(2H)-dione (14) 
(15) 
810 68119 __ neopentyl glycol, diesters and monoesters 
with benzoic acid and 2-ethylhexanoic 
acid yes no no 5 (32) Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down.  
811 80077 0068441-17-8 polyethylene waxes, oxidised yes no no 60    
812 80350 0124578-12-7 poly(12-hydroxystearic acid)-
polyethyleneimine copolymer yes no no   Only to be used in 
polyethylene terephthalate 
(PET), polystyrene (PS), high 
impact polystyrene (HIPS) 
and polyamide (PA) up to 0,1 
% w/w. 
 
Prepared by the reaction of 
poly(12-hydroxystearic acid) 
with polyethyleneimine.  
813 91530 — sulphosuccinic acid alkyl (C 4-C20) or 
cyclohexyl diesters, salts yes no no 5    
814 91815 — sulphosuccinic acid monoalkyl (C 10-C16) 
polyethyleneglycol esters, salts yes no no 2    
815 94985 — trimethylolpropane, mixed triesters and 
diesters with benzoic acid and 2-
ethylhexanoic acid  yes no no 5 (32) Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down  
816 45704 — cis-1,2-cyclohexanedicarboxylic acid, 
salts yes no no 5    
817 38507 — cis-endo-bicyclo[2.2.1]heptane-2,3-
dicarboxylic acid, salts yes no no 5  Not to be used with 
polyethylene in contact with 
acidic foods. 
 
Purity ≥ 96 %.  
818 21530 — methallylsulphonic acid, salts no yes no 5    
819 68110 — neodecanoic acid, salt s yes no no 0,05  Not to be used in polymers   
EN 82   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
contacting fatty foods. 
 
Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down. 
 
SML expressed as 
neodecanoic acid. 
820 76420 — pimelic acid, salts yes no no     
821 90810 — stearoyl-2-lactylic acid, salts yes no no     
822 71938 — perchloric acid, salts yes no no 0,05   (4) 
823 24889 — 5-Sulphoisophthalic acid, salts no yes no 5    
854 71943 0329238-24-6 perfluoro acetic acid, α-substituted with 
the copolymer of perfluoro-1,2-propylene 
glycol and perfluoro-1, 1-ethylene glycol, 
terminated with 
chlorohexafluoropropyloxy groups yes no no   Only to be used in 
concentrations up to 0,5 % 
w/w in the polymerisation of 
fluoropolymers that are 
processed at temperatures at 
or above 340 °C and are 
intended for use in repeated 
use articles   
860 71980 0051798-33-5 perfluoro[2-(poly(n-propoxy))propanoic 
acid] yes no no   Only to be used in the 
polymerisation of 
fluoropolymers that are 
processed at temperatures at 
or above 265 °C and are 
intended for use in repeated 
use articles  
861 71990 0013252-13-6 perfluoro[2-(n-propoxy)propanoic acid] yes no no   Only to be used in the 
polymerisation of 
fluoropolymers that are 
processed at temperatures at 
or above 265 °C and are 
intended for use in repeated 
use articles   
EN 83   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
862 15180 0018085-02-4 3,4-diacetoxy-1-butene no yes no 0,05  SML including the hydrolysis 
product 3,4-dihydroxy-1-
butene. 
 
Only for use as a co-
monomer for ethyl vinyl 
alcohol copolymers.  
864 46330 0000056-06-4 2,4-diamino-6-hydroxypyrimidine yes no no 5  Only to be used in rigid 
poly(vinyl chloride) (PVC) in 
contact with non-acidic and 
non-alcoholic aqueous food  
865 40619 0025322-99-0 (butyl acrylate, methyl methacrylate, 
butyl methacrylate) copolymer yes no no   Only to be used in rigid 
poly(vinyl chloride) (PVC) at 
a maximum level of 1%  
866 40620 — (butyl acrylate, methyl methacrylate) 
copolymer, cross-linked with allyl 
methacrylate yes no no   Only to be used in rigid 
poly(vinyl chloride) (PVC) at 
a maximum level of 7%  
867 40815 0040471-03-2 (butyl methacrylate, ethyl acrylate, 
methyl methacrylate) copolymer yes no no   Only to be used in rigid 
poly(vinyl chloride) (PVC) at 
a maximum level of 2%  
868 53245 0009010-88-2 (ethyl acrylate, methyl methacrylate) 
copolymer yes no no   Only to be used in rigid 
poly(vinyl chloride) (PVC) at 
a maximum level of 2%  
869 66763 0027136-15-8 (butyl acrylate, methyl methacrylate, 
styrene) copolymer yes no no   Only to be used in rigid 
poly(vinyl chloride) (PVC) at 
a maximum level of 3%  
870 95500 0160535-46-6 N,N’,N’’-tris(2-methylcyclohexyl)-1,2,3-
propane-tricarboxamide yes no no 5    
875 80345 0058128-22-6 poly(12-hydroxystearic acid) stearate yes no yes 5    
878 31335 — acids, fatty (C8-C22) from animal or 
vegetable fats and oils, esters with 
branched alcohols, a liphatic, m onohydric, 
saturated, primary (C3-C22) yes no no     
879 31336 — acids, fatty (C8-C22) from animal or yes no no      
EN 84   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
vegetable fats and oils, esters with 
alcohols, linear, aliphatic, monohydric, 
saturated, primary (C1-C22) 
880 31348 0085116-93-4 acids, fatty (C8-C22), esters with 
pentaerythritol yes no no     
881 25187 0003010-96-6 2,2,4,4-tetramethylcyclobutane-1,3-diol  no yes no 5  Only for repeated use articles 
for long term storage at room 
temperature or below and 
hotfill  
882 25872 0002416-94-6 2,3,6-trimethylphenol no yes no 0,05    
883 22074 0004457-71-0 3-methyl-1,5-pentanediol no yes no 0,05  Only to be used in materials 
in contact with food at a 
surface to mass ratio up to 0,5 
dm²/kg  
884 34240 0091082-17-6 alkyl(C10-C21)sulphonic acid, esters 
with phenol yes no no 0,05  Not to be used for articles in 
contact with fatty foods for 
which simulant D is laid 
down.  
885 45676 0263244-54-8 cyclic oligomers of (butylene 
terephthalate) yes no no   Only to be used in 
poly(ethylene terephthalate) 
(PET), poly(butylene 
terephthalate) (PBT), 
polycarbonate (PC), 
polystyrene (PS) and rigid 
poly(vinyl chloride) (PVC) 
plastics in concentrations up 
to 1% w/w, in contact with 
aqueous, acidic and alcoholic 
foods, for long term storage at 
room temperature.   
EN 85   EN 2. Group restriction of substances 
Table 2 on Group restrictions contai ns the following information:  
Column 1 (Group restriction No): contains the identification number of the group of 
substances for which the group restriction a pplies. It is the nu mber referred to in 
Column 9 in Table 1 of this Annex. 
Column 2 (FCM Substance No): contains the unique identificat ion numbers of the 
substances for which the group restriction a pplies. It is the nu mber referred to in 
Column 1 in Table 1 of this Annex. 
Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum 
of substances applicable to this group. It is e xpressed in mg substance per kg food. It 
is indicated ND if the substance shall not  migrate in detectable quantities.  
Column 4 (Group restriction specification): contains an indication of the substance 
whose molecular weight forms the ba sis for expression of the result. 
Table 2 
(1) (2) (3) (4) 
Group 
Restric-
tion No FCM 
substance 
No SML (T) 
[mg/kg] Group restriction specification 
1 128 
211 6 expressed as acetaldehyde 
2 89 
227 
263 30 expressed as ethyleneglycol  
3 234 
248 30 expressed as maleic acid 
4 212 
435 15 expressed as caprolactam 
5 137 
472 3 expressed as the sum of the substances 
6 412 
512 513 588 1 expressed as iodine 
7 19 
20 1,2 expressed as tertiary amine  
EN 86   EN (1) (2) (3) (4) 
8 317 
318 319 359 
431 
464 6 expressed as the sum of the substances 
9 650 
695 697 698 726 0,18 expressed as tin 
10 28 
29 
30 
31 32 33 
466 
582 
618 619 620 646 676 
736 0,006 expressed as tin 
11 66 
645 
657 1,2 expressed as tin 
12 444 
469 470 30 expressed as the sum of the substances 
13 163 
285 1,5 expressed as the sum of the substances 
14 294 
368 5 expressed as the sum of the substances 
15 98 
196 15 expressed as formaldehyde 
16 407 
583 584 
599 6 expressed as boron 
Without prejudice to the provisions of Directive 
98/83/EC  
EN 87   EN (1) (2) (3) (4) 
17 4 
167 169 198 
274 
354 372 460 461 
475 
476 485 490 653 ND expressed as isocyanate moiety 
18 705 
733 0,05 expressed as the sum of the substances 
19 505 
516 
519 10 expressed as SO 2 
20 290 
386 
390 30 expressed as the sum of the substances 
21 347 
349 5 expressed as trimellitic acid 
22 70 
147 176 218 323 
325 
365 371 380 425 446 
448 
456 636 6 expressed as acrylic acid  
EN 88   EN (1) (2) (3) (4) 
23 150 
156 181 183 
184 
355 370 374 439 
440 
447 457 482 6 expressed as methacrylic acid  
24 756 
758 5 expressed as the sum of the substances 
25 720 
747 0,05 sum of mono-n-dodecyltin 
tris(isooctylmercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin 
trichloride and di-dodecylt in dichloride) expressed 
as the sum of mono- and di-dodecyltin chloride 
26 728 
729 9 expressed as the sum of the substances 
27 188 
291 5 expressed as isophthalic acid 
28 191 
192 785 7,5 expressed as terephthalic acid 
29 342 
672 0,05 expressed as the sum of 6-hydroxyhexanoic acid 
and caprolactone 
30 254 
672 5 expressed as 1,4-butanediol 
31 73 
797 30 expressed as the sum of the substances  
EN 89   EN (1) (2) (3) (4) 
32 8 
72 73 
138 
140 
157 159 207 242 
283 
532 670 728 729 775 
783 
797 798 810 815 60 expressed as the sum of the substances 
  
EN 90   EN 3. Notes on verification of compliance 
Table 3 on notes on verification of complia nce contains the following information: 
Column 1 (Note No): contains the identific ation number of the Note. It is the number 
referred to in Column 11 in Table 1 of this Annex. 
Column 2 (Notes on verifica tion of compliance): contains rules that shall be 
respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-
compliance. 
Table 3 
(1) (2) 
Note No Notes on verification of compliance  
(1) Verification of compliance by residual co ntent per food contact surface area (QMA) 
pending the availability of an analytical method. 
(2) There is a risk that the SML or OML c ould be exceeded in fatty food simulants. 
(3) There is a risk that the migration of the substance deteriorates the organoleptic 
characteristics of the food in contact and th en, that the final product does not comply 
with Article 3 (1) c of the Framework Regulation (EC) No 1935/2004. 
(4) Compliance testing when there is a fat contact should be performed using saturated fatty 
food simulants as simulant D. 
(5) Compliance testing when there is a fat contact should be performed using isooctane as 
substitute of simulant D2 (unstable). 
(6) Migration limit might be exceeded at very high temperature. 
(7) If testing in food is performed, Annex V 1.4. shall be taken into account. 
(8) Verification of compliance by residual c ontent per food contact surface area (QMA); 
QMA = 0,005 mg/6 dm². 
(9) Verification of compliance by residual co ntent per food contact surface area (QMA) 
pending the availability of anal ytical method for migration testing. The ratio surface to 
quantity of food shall be lower than 2dm²/kg. 
(10) Verification of compliance by residual co ntent per food contact surface area (QMA) in 
case of reaction with food or simulant. 
(11) Only a method of analysis for the determination of the residual monomer in the treated 
filler is available. 
(12) There is a risk that the SML could be exceeded from polyolefins. 
(13) Only a method for determination of the content in polymer and a method for 
determination of the starting substances in food simulants are available.  
EN 91   EN (14) There is a risk that the SML could be  exceeded from plastics containing more than 
0,5 % w/w of the substance. 
(15) There is a risk that the SML could be excee ded in contact with foods with high alcoholic 
content. 
(16) There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) 
containing more than 0,3 % w/w of the su bstance when in contact with fatty foods 
(17) Only a method for determination of the residual content of the substance in the polymer 
is available 
  
EN 92   EN 4. Detailed specification on substances 
Table 4 on detailed specifications on subs tances contains the following information 
Column 1 (FCM Substance No): contains the unique identifica tion number of the 
substances referred to in Column 1 in Tabl e 1 of Annex I to which the specification 
applies.  
Column 2 (Detailed specification on the substance): contains the specification on the 
substance.  
EN 93   EN Table 4 
(1) (2) 
FCM 
substance No Detailed specification on the substance 
Definition The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic 
acid as carbon sources. The organism used has not been geneti cally engineered and has been derived from a single wildtype 
organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism  are stored as freeze-dried ampoules. A 
submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the 
fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a 
variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of  
the other cellular components, washing and drying. These copolym ers are normally offered as formulated, melt formed granules 
containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the genera l and 
individual specifications 
Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) 
CAS number 0080181-31-3 744 
Structural formula 
 
 
 
where n/(m + n) greater than 0 and less or equal to 0,25   
EN 94   EN Average 
molecular weight Not less than 150 000 Daltons (measured by gel permeation chromatography) 
Assay Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentan oate) analysed after hydrolysis as a mixture of 3-D-hydro-
xybutanoic and 3-D-hydroxypentanoic acids 
Description White to off-white powder after isolation 
Characteristics  
Identification tests:  
Solubility Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkan es 
and water 
Restriction QMA for crotonic acid is 0.05 mg/6 dm2 
Purity Prior to granulation the raw material copolymer powder must contain: 
– nitrogen Not more than 2 500 mg/kg of plastic 
– zinc Not more than 100 mg/kg of plastic 
– copper Not more than 5 mg/kg of plastic 
– lead Not more than 2 mg/kg of plastic 
– arsenic Not more than 1 mg/kg of plastic 
– chromium Not more than 1 mg/kg of plastic 
  
EN 95   EN ANNEX II  
 
Restrictions on materials and articles  
1. Plastic materials and articles shall not re lease the following substances in quantities 
exceeding the specific migration limits below: 
Barium = 1 mg/kg food or food simulant. Cobalt = 0.05 mg/kg food or food simulant. Copper = 5 mg/kg food or food simulant. Iron = 48 mg/kg food or food simulant. Lithium = 0.6 mg/kg food or food simulant. Manganese = 0.6 mg/kg food or food simulant. Zinc = 25 mg/kg food or food simulant.  
2. Plastic materials and articles shall not release primary aromatic amines, excluding 
those appearing in Table 1 of  Annex I, in a detectable quantity into food or food 
simulant. The detection limit is 0.01 mg of substance per kg of food or food 
simulant. The detection limit applies to the sum of primary aromatic amines released.  
EN 96   EN ANNEX III  
 
Food simulants  
1. Food simulants 
For demonstration of compliance for plastic materials and articles not yet in contact 
with food the food simulants listed in Table 1 below are assigned.  
Table 1 List of food simulants 
Food Simulant Abbreviation 
Ethanol 10 % (v/v) Food Simulant A 
Acetic acid 3 % (w/v) Food Simulant B 
Ethanol 20 % (v/v) Food Simulant C 
Ethanol 50 % (v/v) Food Simulant D1 
Vegetable Oil* Food Simulant D2 
poly(2,6-diphenyl-p-
phenylene oxide), particle size 60-80 mesh, pore size 200 nm Food Simulant E 
 
* This may be any vegetable oil with a fatty acid distribution of  
No of carbon atoms in fatty acid 
chain: No of unsaturation  6-12 14 16 18:0 18:1 18:2 18:3 
Range of fatty acid composition 
expressed % (w/w) of methyl esters by Gas chromatography <1 <1 1.5 - 20 <7 15-85 5-70 <1.5 
 
2. General assignment of food simulants to foods 
Food simulants A, B and C are assigned for foods that have a hydrophilic character 
and are able to extract hydr ophilic substances. Food simula nt B shall be used for 
those foods which have a pH below 4.5. Food simulant C should be used for 
alcoholic foods with an alcohol content of  up to 20% and those foods which contain 
a relevant amount of organic ingredients that render the food more lipophilic. 
Food simulants D1 and D2 are assigned for foods that have a lipophilic character and 
are able to extract li pophilic substances. Food simulant D1  shall be used  for alcoholic  
EN 97   EN foods with an alcohol content of above 20% and for oil in water emulsions. Food 
simulant D2 shall be used for foods which contain free fats at the surface. 
Food simulant E is assigned for tes ting specific migration into dry foods. 
3. Specific assignment of food simulants to f oods for migration testing of materials and 
articles not yet in contact with food 
For testing migration from mate rials and articles not yet in  contact with food the food 
simulants that corresponds to a certain  food category shall be chosen according 
table 2 below. 
For testing overall migration of materials and articles intended to come into contact 
with different food categories or a combin ation of food categories the food simulant 
assignment in point 4 is applicable. 
Table 2 contains the following information: Column 1 (Reference number): contains th e reference number of the food category. 
Column 2 (Description of food): contains a description of the foods covered by the 
food category 
Column 3 (Food Simulant): contains sub- columns for each of the food simulants 
The food simulant for which a cross is c ontained in the respective sub-column of 
column 3 shall be used when testing migra tion of materials and articles not yet in 
contact with food.  
For food categories where in sub-column D2 the cross is followed by an oblique 
stroke and a figure, the migration test resu lt shall be divided by this figure before 
comparing the result with the migration limit. The figure is the correction factor referred to in point 4.2 of Annex V to this Regulation. 
For food category 01.04. food simulant D2  shall be replaced by 95% Ethanol 
For food categories where in sub-column B th e cross is followed by (*) the testing in 
food simulant B can be omitted if th e food has a pH of more than 4.5. 
For food categories where in sub-column D2 the cross is followed by (**) the testing 
in food simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is  no `fatty contact’ with the plastic food contact material.
   
EN 98   EN Table 2 food category specific as signment of food simulants 
(1) (2) (3) 
Food Simulants Reference 
number Description of food 
A B C D1 D2 E 
01 Beverages       
01.01 Non-alcoholic beverages or  alcoholic beverages of an 
alcoholic strength lower than or equal to 6% vol.:        
 A. Clear drinks:  
Water, ciders, clear fruit or vegetable juices of normal 
strength or concentrated, fruit nectars, lemonades, syrups, 
bitters, infusions, coffee, tea, beers, soft drinks, energy 
drinks and the like, flavoured water, liquid coffee extract  X(*) X    
 B. cloudy drinks: 
juices and nectars and soft drinks containing fruit pulp, 
musts containing fruit pulp, liquid chocolate  X(*)  X   
01.02 Alcoholic beverages of an alcoholic strength of between 
6%vol and 20%.   X     
01.03 Alcoholic beverages of an alcoholic strength above 20% 
and all cream liquors    X    
01.04 Miscellaneous: undenaturated ethyl alcohol  X(*)   Substi-
tute 
95 % 
Ethanol  
02 Cereals, cereal products, pastry, biscuits, cakes and 
other bakers’ wares       
02.01 Starches      X 
02.02 Cereals, unprocesse d, puffed, in flakes (including popcorn, 
corn flakes and the like)      X  
02.03 Cereal flour and meal      X 
02.04 Dry pasta e.g. macaroni, spaghetti and similar products 
and fresh pasta       X  
02.05 Pastry, biscuits, cakes, bread, and other bakers' wares, dry:       
 A. With fatty substances on the surface      X/3  
 B .  O t h e r       X  
02.06 Pastry, cakes, bread, dough and other bakers' wares, fresh:       
 A. With fatty substances on the surface      X/3   
EN 99   EN  B .  O t h e r       X  
03 Chocolate, sugar and products thereof  
Confectionery products        
03.01 Chocolate, chocolate-coat ed products, substitutes and 
products coated with substitutes     X / 3   
03.02 Confectionery products:       
 A. In solid form:       
 I. With fatty substances on the surface     X/3  
 II. Other      X 
 B. In paste form:       
 I. With fatty substances on the surface     X/2  
 II. Moist   X    
03.03 Sugar and sugar products       
 A. In solid form: crystal or powder      X 
 B. Molasses, sugar syrups, honey and the like X      
04 Fruit, vegetables and products thereof       
04.01 Whole fruit, fresh or ch illed, unpeeled       
04.02 Processed fruit:       
 A. Dried or dehydrated fruits, whole, sliced, flour or 
powder      X  
 B. Fruit in the form of purée, preserves, pastes or in its 
own juice or in sugar syrup (jams, compote, and 
similar products)  X(*) X    
 C. Fruit preserved in a liquid medium:       
 I. In an oily medium     X  
 II. In an alcoholic medium     X   
04.03 Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, 
pine kernels and others):       
 A. Shelled, dried, flaked or powdered      X 
 B. Shelled and roasted      X 
 C. In paste or cream form X    X  
04.04 Whole vegetables, fresh or  chilled, unpeeled       
04.05 Processed vegetables:        
EN 100   EN  A. Dried or dehydrated vegetables whole, sliced or in the 
form of flour or powder      X  
 B. Fresh vegetables, pe eled or cut X      
 C. Vegetables in the form of purée, preserves, pastes or 
in its own juice (including pickled and in brine)  X(*) X    
 D. Preserved vegetables:       
 I. In an oily medium X    X  
 II. In an alcoholic medium    X   
05 Fats and oils        
05.01 Animals and vegetable fats and oils, whether natural or 
treated (including cocoa butter, lard, resolidified butter)     X   
05.02 Margarine, butter and other fats and oils made from water 
emulsions in oil     X / 2   
06 Animal products and eggs       
06.01 Fish:       
 A. Fresh, chilled, processe d, salted or smoked including 
fish eggs X    X/3 (**)  
 B .  P r e s e r v e d  f i s h :        
 I. In an oily medium X    X  
 II. In an aqueous medium  X(*) X    
06.02 Crustaceans and molluscs (including oysters, mussels, 
snails)        
 A Fresh within the shell       
 B Shell removed, processed,  preserved or cooked with 
the shell       
 I. In an oily medium X    X  
 II. In an aqueous medium  X(*) X    
06.03 Meat of all zoological species (including poultry and 
game):       
 A. Fresh, chilled, salted, smoked X    X/4 (**)  
 B. Processed meat products (s uch as ham, salami, bacon, 
sausages, and other) or in the form of paste, creams X    X/4 (**)  
 C. Marinated meat products in  an oily medium X    X  
06.04 Preserved meat:       
 A. In an fatty or oily medium  X    X/3  
 B. In an aqueous medium   X(*)  X    
EN 101   EN 06.05 Whole eggs, egg yolk, egg white       
 A. Powdered or dried or frozen      X 
 B. Liquid and cooked    X   
07 Milk products       
07.01 Milk        
 A. Milk and milk based dri nks whole, partly dried and 
skimmed or partly skimmed    X   
 B. Milk powder including infant formula (based on 
whole milk powder)      X 
07.02 Fermented milk such as yoghurt, buttermilk and similar 
products   X(*)  X   
07.03 Cream and sour cream  X(*)  X   
07.04 Cheeses:       
 A. Whole, with not edible rind      X 
 B. Natural cheese without rind or with edible rind 
(gouda, camembert, and the li ke) and melting cheese     X/3(**)  
 C. Processed cheese (soft cheese, cottage cheese and 
similar)  X(*)  X   
 D. Preserved cheese:       
 I. In an oily medium X    X  
 II. In an aqueous medium (feta, mozarella, and 
similar)  X(*)  X   
08 Miscellaneous products       
08.01 Vinegar  X     
08.02 Fried or roasted foods:       
 A. Fried potatoes, fritters and the like X    X/5  
 B. Of animal origin X    X/4  
08.03 Preparations for soups, broths , sauces, in liquid, solid or 
powder form (extracts, co ncentrates); homogenized 
composite food preparations, prepared dishes including 
yeast and raising agents       
 A. Powdered or dried:       
 I. With fatty character     X/5  
 II. Other      X  
EN 102   EN  B. any other form than powdered or dried:       
 I. With fatty character X X(*)   X/3  
 II. Other  X(*) X    
08.04 Sauces:       
 A. With aqueous character  X(*) X    
 B. With fatty character e.g.  mayonnaise, sauces derived 
from mayonnaise, salad cr eams and other oil/water 
mixtures e.g. coconut based sauces X X(*)   X  
08.05 Mustard (except powdered mustard under heading 08.14) X X(*)   X/3 (**)  
08.06 Sandwiches, toasted bread pizza and the like containing 
any kind of foodstuff       
 A. With fatty substances on the surface X    X/5  
 B .  O t h e r       X  
08.07 Ice-creams   X    
08.08 Dried foods:       
 A. With fatty substances on the surface     X/5  
 B .  O t h e r       X  
08.09 Frozen or deep-frozen foods      X 
08.10 Concentrated extracts of an  alcoholic strength equal to or 
exceeding 6% vol.  X(*)  X   
08.11 Cocoa:       
 A. Cocoa powder, including fat-reduced and highly fat 
reduced      X  
 B. Cocoa paste     X/3  
08.12 Coffee, whether or not roaste d, decaffeinated or soluble, 
coffee substitutes, granulated or powdered      X  
08.13 Aromatic herbs and othe r herbs such as camomile, 
mallow, mint, tea, lime blossom and others      X  
08.14 Spices and seasonings in the natural state such as 
cinnamon, cloves, powdered mu stard, pepper, vanilla, 
saffron, salt and other      X  
08.15 Spices and seasoning in oily medium such as pesto, curry 
paste     X   
  
EN 103   EN 4. Food simulant assignment for testing Overall migration 
To demonstrate compliance with the overall migration limit for all type of foods 
testing in distilled water or water of equi valent quality or food simulant A and food 
simulant B and simulant D2 shall be performed. 
To demonstrate compliance with the overa ll migration limit for all types of food 
except for acidic foods testing in distilled water or water of equivalent quality or 
food simulant A and food simulant D2 shall be performed. 
To demonstrate compliance with the overa ll migration limit for all aqueous and 
alcoholic foods and milk products testing in food simulant D1 shall be performed. 
To demonstrate compliance with the overall migration limit for all aqueous, acidic 
and alcoholic foods and milk products testi ng in food simulant D1 and food simulant 
B shall be performed. 
To demonstrate compliance with the overa ll migration limit for all aqueous foods 
and alcoholic foods up to an alcohol content of 20% testing in food simulant C shall be performed.  
To demonstrate compliance with the overa ll migration limit for all aqueous and 
acidic foods and alcoholic foods up to an alcohol content of 20% testing in food 
simulant C and food simulant B shall be performed.  
EN 104   EN ANNEX IV  
 
Declaration of compliance  
The written declaration referred to in Article  15 shall contain the following information: 
(1) the identity and address of the business operator issuing the declaration of 
compliance; 
(2) the identity and address of the business operator which manufactures or imports the 
plastic materials or articl es or products from interm ediate stages of their 
manufacturing or the substa nces intended for the manufacturing of those materials 
and articles; 
(3) the identity of the materials, the articl es, products from intermediate stages of 
manufacture or the substances  intended for the manufactur ing of those materials and 
articles; 
(4) the date of the declaration; (5) confirmation that the plastic materials or articles, products from intermediate stages 
of manufacture or the substances meet rele vant requirements laid down in this 
Regulation and Regulat ion (EC) No 1935/2004; 
(6) adequate information relative to the s ubstances used or products of degradation 
thereof for which restrictions and/or specifi cations are set out in Annexes I and II to 
this Regulation to allow the downstream business operators to ensure compliance with those restrictions; 
(7) adequate information relative to the substances which are subject to a restriction in 
food, obtained by experimental data or theore tical calculation about the level of their 
specific migration and, where appropriate , purity criteria in accordance with 
Directives 2008/60/EC, 95/45/ EC and 2008/84/EC to enable the user of these 
materials or articles to comply with the re levant EU provisions or , in their absence, 
with national provisions applicable to food; 
(8) specifications on the use of the material or article, such as: 
(i) type or types of food with which it is intended to be  put in contact; 
(ii) time and temperature of treatment and storage in contact with the food; 
(iii) ratio of food contact surface area to vo lume used to establish the compliance of 
the material or article; 
(9) when a functional barrier is used in a multi-layer material or article, the confirmation 
that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.  
EN 105   EN ANNEX V  
 
Compliance testing  
For testing compliance of migr ation from plastic food contact  materials and articles the 
following general rules apply. 
Chapter 1 
 
Testing for specific migration of ma terials and articl es already in 
contact with food 
1.1. Sample preparation 
The material or article shall be stored as indicated on the p ackaging label or under 
conditions adequate for the packaged food if  no instructions are given. The food shall 
be removed from contact with the material or  article before its e xpiration date or any 
date by which the manufacturer has indica ted the product should be used for reasons 
of quality or safety. 
1.2. Conditions of testing 
The food shall be treated in accordance with  the cooking instructions on the package 
if the food is to be cooked in the package. Parts of the food which are not intended to 
be eaten shall be removed and discarde d. The remainder shall be homogenised and 
analysed for migration. The an alytical results shall always  be expressed on the basis 
of the food mass that is intended to be  eaten, in contact with the food contact 
material. 
1.3. Analysis of migrated substances 
The specific migration is analysed in the food using an an alytical method in 
accordance with the requirements of Ar ticle 11 of Regulation (EC) No 882/2004. 
1.4. Special cases 
When contamination occurs from sources ot her than food contact materials this has 
to be taken into account when testing for co mpliance of the food c ontact materials, in 
particular for phthalates (FCM substa nce 157, 159, 283, 728, 729) referred to in 
Annex I.  
EN 106   EN Chapter 2 
 
Testing for specific migration of ma terials and articl es not yet in 
contact with food 
2.1. Verification method 
Verification of compliance of migration into  foods with the migration limits shall be 
carried out under the most extreme conditions  of time and temperature foreseeable in 
actual use taking into account paragraphs 1.4, 2.1.1, 2.1.6 and 2.1.7. 
Verification of compliance of migration into  food simulants with the migration limits 
shall be carried out using conventional migr ation tests according to the rules set out 
in paragraphs 2.1.1 to 2.1.7. 
2.1.1. Sample preparation 
The material or article shall be treated as described by accompanying instructions or 
by provisions given in the d eclaration of compliance. 
Migration is determined on the material or article or, if this is impractical, on a 
specimen taken from the material or article, or a specimen representative of this material or article. For each food simulant or food type, a new test specimen is used. 
Only those parts of the sample which are inte nded to come into contact with foods in 
actual use shall be placed in contact with the food simulant or the food. 
2.1.2. Choice of food simulant 
Materials and articles intended for contact with  all types of food shall be tested with 
food simulant A, B and D2. However, if s ubstances that may re act with acidic food 
simulant or foods are not present test ing in food simulant B can be omitted. 
Materials and articles intended only for speci fic types of foods shall be tested with 
the food simulants indicated for the food types in Annex III. 
2.1.3. Conditions of contact when using food simulants 
The sample shall be placed in contact  with the food simulant in a manner 
representing the worst of the foreseeable c onditions of use as regard contact time in 
Table 1 and as regard cont act temperature in Table 2. 
If it is found that carrying out the tests under the combination of contact conditions 
specified in table 1 and 2 causes physical or  other changes in the test specimen which 
do not occur under worst foreseeable conditions  of use of the material or article 
under examination, the migration tests shall be carried out under the worst 
foreseeable conditions of use in which thes e physical or other changes do not take 
place.  
EN 107   EN Table 1 Contact time 
Contact time in worst 
foreseeable use Test time 
t ≤ 5 min 5 min 
5 min < t ≤ 0.5 hour 0.5 hour 
0.5 hours < t ≤ 1 hour 1 hour 
1 hour < t ≤ 2 hours 2 hours 
2 hours < t ≤ 6 hours 6 hours 
6 hours < t ≤ 24 hours 24 hours 
1day < t ≤ 3 days 3 days 
3 days < t ≤ 30 days 10 days 
Above 30 days  See specific conditions  
 
Table 2 Contact temperature 
Conditions of contact in worst 
foreseeable use Test conditions 
Contact temperature Test temperature 
T ≤ 5 °C 5 °C 
5 °C < T ≤ 20 °C  20 °C 
20 °C < T ≤ 40 °C 40 °C 
40 °C < T ≤ 70 °C 70 °C 
70 °C < T ≤ 100 °C 100 °C or reflux temperature 
100 °C < T ≤ 121 °C 121 °C(*) 
121 °C < T ≤ 130 °C 130 °C (*) 
130 °C < T ≤ 150 °C 150 °C (*)  
EN 108   EN 150 °C < T < 175 °C 175 °C (*) 
T > 175 °C Adjust the te mperature to the real 
temperature at the in terface with the food 
(*) 
(*) This temperature shall be used only for food simulants D2 and E. For 
applications heated under pressure migration testi ng under pressure at the 
relevant temperature may be performed. For food simulants A, B,C or D1 the 
test may be replaced by a test at 100 °C or at reflux temperature for duration of 
four times the time selected according to the conditions in Table1. 
 
2.1.4. Specific conditions for contact times above  30 days at room temperature and below 
For contact times above 30 days at room temperature and below the specimen shall 
be tested in an accelerated test at elevat ed temperature for a maximum of 10 days at 
60 ºC. Testing time and temperature condi tions shall be based on the following 
formula. 
t2 = t1 * Exp ((-Ea/R) *(1/T1-1/T2)) 
Ea is the worst case ac tivation energy 80kJ/mol 
R is a factor 8.31 J/Kelvin/mol Exp -9627 * (1/T1-1/T2) t1 is the contact time t2 is the testing time  T1 is the contact temperature in Kelvin. For room temperature storage this is set at 
298 K (25 °C). For refrigerated and frozen  conditions it is set at 278 K (5 °C). 
T2 is the testing temperature in Kelvin. 
Testing for 10 days at 20 °C shall cove r all storage times at frozen condition 
Testing for 10 days at 40 °C shall cover a ll storage times at refrigerated and frozen 
conditions including heating up to 70°C for up to 2 hours, or heating up to 100°C for 
up to 15 minutes 
Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen 
conditions including heating up to 70°C for up to 2 hours, or heating up to 100°C for 
up to 15 minutes and storage times of up to 6 months at room temperature  
EN 109   EN Testing for 10 days at 60 °C shall cover long term storage above 6 months at room 
temperature and below including heating up to  70°C for up to 2 hours, or heating up 
to 100°C for up to 15 minutes 
The maximum testing temperature is governed  by the phase transition temperature of 
the polymer. At the test temperature the test specimen should not undergo any 
physical changes.  
For storage at room temperature testing tim e can be reduced to 10 days at 40 °C if 
there is scientific evidence that migration of the respective subs tance in the polymer 
has reached equilibration under this test condition. 
2.1.5. Specific conditions for combinations  of contact times and temperature 
If a material or article is intended fo r different applications covering different 
combinations of contact time and temperatur e the testing should be  restricted to the 
test conditions which are rec ognized to be the most severe  on the basis of scientific 
evidence. 
If the material or article is intended for a food contact application where it is 
successively subject to a combination of two or more times and temperatures, the 
migration test shall be carried out subjecti ng the test specimen successively to all the 
applicable worst foreseeable conditions ap propriate to the sample, using the same 
portion of food simulant.  
2.1.6. Repeated use articles 
If the material or article is intended to come into repeated c ontact with foods, the 
migration test(s) shall be carried out thre e times on a single sample using another 
portion of food simulant on each occasion. Its compliance shall be checked on the 
basis of the level of the migr ation found in the third test.  
However, if there is conclusive proof that the level of the migration does not increase 
in the second and third tests and if the mi gration limits are not exceeded on the first 
test, no further test is necessary. 
The material or article shal l respect the specific migration limit already in the first 
test for substances for whic h in Annex I table 1 column 8 or table 2 column 3 the 
specific migration limit is set as non-dete ctable and for non-lis ted substances used 
behind a plastic functional ba rrier covered by the rules of point (b) of Articles 13 (2) 
which should not migrate in detectable amounts. 
2.1.7. Analysis of migrating substances 
At the end of the prescribed  contact time, the specific migration is analysed in the 
food or food simulant using an analyt ical method in acco rdance with the 
requirements of Article 11 of  Regulation (EC) No 882/2004. 
2.1.8. Verification of compliance by residual content per food cont act surface area (QMA) 
For substances which are unstable in food simulant or food or for which no adequate 
analytical method is available it is in dicated in Annex I that verification of  
EN 110   EN compliance shall be undertaken by veri fication of residual content per 6 dm2 of 
contact surface. For materials and articles  between 500 ml and 10 l the real contact 
surface is applied. For materials and articl es below 500 ml and above 10 l as well as 
for articles for which it is impractical to cal culate the real contact surface the contact 
surface is assumed to be 6 dm2 per kg food. 
2.2. Screening approaches 
To screen if a material or article comp lies with the migration limits any of the 
following approaches can be applied which are considered more severe than the 
verification method desc ribed in section 2.1.  
2.2.1. Replacing specific migration by overall migration 
To screen for specific migr ation of non-volatil e substances, determination of overall 
migration under test conditions at least as severe as for specific migration can be applied. 
2.2.2. Residual content 
To screen for specific migration the migra tion potential can be calculated based on 
the residual content of the substance in the material or article assuming complete migration. 
2.2.3. Migration modelling 
To screen for specific migration the migra tion potential can be calculated based on 
the residual content of the substance in th e material or article applying generally 
recognised diffusion models base d on scientific evidence that are constructed such as 
to overestimate real migration. 
2.2.4. Food simulant substitutes 
To screen for specific migration, food si mulants can be replaced by substitute food 
simulants if it is based on scientific evidence that the substitute food simulants 
overestimate migration compared to  the regulated food simulants.  
Chapter 3 
 
Testing for overall migration 
Overall migration testing shall be performed un der the standardised te sting conditions set out 
in this chapter. 
3.1. Standardised testing conditions 
The overall migration test for materials a nd articles intended for the food contact 
conditions described in column 3 of table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed 
either for 2 hours at 100°C (food simulant D2 ) or at reflux (food simulant A, B, C,  
EN 111   EN D1) or for 1 hour at 121°C. The food simula nt shall be chosen in accordance with 
Annex III. 
If it is found that carrying out the tests under the co ntact conditions specified in 
table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of us e of the material or article under 
examination, the migration tests shall be  carried out under the worst foreseeable 
conditions of use in which these physical or other changes do not take place. 
Table 3: Standardised testing conditions 
Column 1 Column 2 Column 3 
Test Number Contact time in days [d] or hours [h] 
at 
Contact temperature in [ºC] Intended food contact 
conditions 
OM 1 10d at 20°C Any food contact at frozen 
and refrigerated conditions. 
OM2 10 d at 40°C Any long term storage at 
room temperature or below, including heating up to 70°C for up to 2 hours, or heating up to 100°C for up to 15 minutes. 
OM3 2 h at 70°C Any contact conditions that 
include heating up to 70°C for up to 2 hours, or up to 100°C for up to 15 minutes, which are not followed by long term room or refrigerated temperature storage.  
OM4 1h at 100°C High temperature applica-
tions for all food simulants at temperature up to 100°C. 
OM5 2 h at 100°C or at reflux or alternatively 
1 h at 121°C High temperature applica-
tions up to 121°C. 
OM6 4 h at 100°C or at reflux Any food contact conditions 
with food simulants A, B or C, at temperature exceeding 40°C. 
OM7 2 h at 175°C High temperature applica- 
EN 112   EN tions with fatty foods 
exceeding the conditions of OM5.  
 
Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, 
OM4, OM5. It represents the worst case conditions for fatty food simulants in 
contact with non-polyolefins. In  case it is technica lly not feasible to perform OM 7 
with food simulant D2 the test can be replaced as set out in paragraph 3.2. 
Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, 
OM4 and OM5. It represents worst case condi tions for food simulants A, B and C in 
contact with non-polyolefins. 
Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, 
OM4. It represents the worst case conditions  for all food simulants in contact with 
polyolefins.  
Test OM 2 covers also food contact conditions described for OM1 and OM3. 
3.2. Substitute test for OM7 with food simulant D2 
In case it is technically NOT feasible to perform OM7 with food simulant D2 the test 
can be replaced by test OM 8 or OM9. Both test conditions described under the respective test shall be perfor med with a new test sample. 
Test number Test conditions Intended food 
contact conditions Covers the intended 
food contact 
conditions described 
in 
OM 8 Food simulant E for 2 
hours at 175°C and 
Food simulant D2 for  
2 hours at 100°C High temperature 
applications only OM1, OM3, OM4, 
OM5, and OM6 
OM 9 Food simulant E for 2 
hours at 175°C and Food simulant D2 for  
10 days at 40°C High temperature 
applications including long term storage at room temperature OM1, OM2, OM3, 
OM4, OM5 and OM6 
3.3. Repeated use articles 
Where a material or article is intended to come into repeated contact with foods, the 
migration test shall be car ried out three times on a si ngle sample using another 
sample of the food simulant on each occasion.  
Its compliance shall be checked  on the basis of th e level of the migration found in the 
third test. However, if there is conclusive  proof that the level of the migration does  
EN 113   EN not increase in the second and third tests and if the overall migration limit is not 
exceeded on the first test, no further test is necessary. 
3.4. Screening approaches 
To screen if a material or article comp lies with the migration limits any of the 
following approaches can be applied which are considered more severe than the 
verification method describe d in sections 3.1. and 3.2. 
3.4.1. Residual content 
To screen for overall migration the migra tion potential can be calculated based on the 
residual content of migratable  substances determined in a complete extraction of the 
material or article. 
3.4.2. Food simulant substitutes 
To screen for overall migration food simulant s can be replaced if based on scientific 
evidence the substitute f ood simulants overestimate mi gration compared to the 
regulated food simulants. 
Chapter 4 
 
Correction factors applied when comparing migration test results 
with migration limits 
4.1. Correction of specific migration in foods containing more than 20% fat by the Fat 
Reduction Factor (FRF) 
For lipophilic substances for which in Annex I it is indicated in column 7 that the 
FRF is applicable the specific migration ca n be corrected by the FRF. The FRF is 
determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat x 
5) / 100. 
The FRF shall be applied according to the following rules. The migration test results shall be divi ded by the FRF before comparing with the 
migration limits. 
The correction by the FRF is not applicable in the following cases:  
EN 114   EN (a) When the material or arti cle is or is intended to be brought in contact with food 
intended for infants and young children as  defined by Directives 2006/141/EC 
and 2006/129/EC; 
(b) For materials and articles for which it is impracticable to estimate the 
relationship between the surface area a nd the quantity of food in contact 
therewith, for example due to their shape or  use, and the migration is calculated 
using the conventional surface area/ volume conversion factor of 6 dm2/kg. 
The application of the FRF shall not lead  to a specific migration exceeding the 
overall migration limit. 
4.2. Correction of migration into food simulant D2 
For the food categories where in sub-column D2 of column 3 of table 2 of Annex III 
the cross is followed by a figure the migration test result into food simulant D2 shall 
be divided by this figure. 
The migration test results shall be divide d by the correction fact or before comparing 
with the migration limits. 
The correction is not applicable to the speci fic migration for substances in the Union 
list in Annex I for which the specific migra tion limit in column 8 is "not detectable" 
and for non-listed substances used behind a plastic functional ba rrier covered by the 
rules of point (b) of Article 13(2) which should not migrate in detectable amounts. 
4.3. Combination of correction factors 4.1. and 4.2. 
The correction factors described in 4.1 a nd 4.2 can be combined for migration of 
substances for which the FRF is applicable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall not 
exceed 5.  
EN 115   EN ANNEX VI  
 
Correlation tables  
Directive 2002/72/EC This Regulation 
Article 1 (1) Article 1 
Article 1 (2), (3) and (4) Article 2 
Article 1a Article 3 
Article 3 (1), Article 4 (1) and Article 5 Article 5 
Article 4 (2), Article 4a (1) and (4), Article 4d, Annex II (2) and (3) 
and Annex III (2) and (3) Article 6 
Article 4a (3) and (6) Article 7 
Annex II (4) and Annex III (4) Article 8 
Article 3 (1) and Article 4 (1) Article 9 
Article 6 Article 10 
Article 5a (1) and Annex I (8) Article 11 
Article 2 Article 12 
Article 7a  Article 13 
Article 9 (1) and (2) Article 15 
Article 9 (3) Article 16 
Article 7 and Annex I (5a) Article 17 
Article 8 Article 18 
Annex II (3) and Annex III (3) Article 19 
Annex I, Annex II, Annex IV, Annex IVa, Annex V Part B, and 
Annex VI Annex I 
Annex II (2), Annex III (2) and Annex V, Part A Annex II 
Article 8 (5) and Annex VIa  Annex IV 
Annex I  Annex V 
   
EN 116   EN Directive 93/8/EEC This Regulation 
Article 1 Article 11 
Article 1 Article 12 
Article 1 Article 18 
Annex Annex III 
Annex Annex V 
 
Directive 97/48/EC This Regulation 
Annex Annex III 
Annex Annex V