EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Transcription

1 EUROPEA OMMISSIO HEATH & OSUMER PROTETIO ORATE-GEERA Directorate D Food Safety: production and distribution chain D3 - hemical and physical risks; surveillance SAO D3/R (2003) File:IT/SYOPTI DOUMET ( ) SYOPTI DOUMET PROVISIOA IST OF MOOMERS AD ADDITS OTIFIED TO EUROPEA OMMISSIO AS SUBSTAES WHIH MAY BE USED I THE MAUFATURE OF ASTIS ITEDED TO OME ITO OTAT WITH FOODSTUFFS (updated to 25 July 2003) - Please read carefully the Explanatory ote to avoid any misunderstanding. - This document may be found at the following internet address: European ommission - Office: B232 04/17 - B-1049 Brussels - Belgium. Telephone: (32-2) direct line (32-2) Fax: (32-2)

2 Synoptic document OTE FOR READER 1. As the website is not yet completed, a reference is sometimes made to a document or a section, which does not yet appear on the website. 2. As this document will be regularly updated, the pages are not indicated. The reader can add the pages in his/her hard copy and note them in the column n 3 of the table of contents. Moreover the reader will be able to see the dates of latest updates in the table of contents (see column 3). The relevant changes are also indicated in the Section EWS at beginning of the document. 3. areful reading of the homepage of the website will help the reader to understand the structure of the website. onsultation of the document ist of documents will also help the reader to find an overview of the main arguments discussed in the website. 4. To know the meaning of some abbreviations and words, consult the document ist of the abbreviations and explanations. 5. If you notice mistakes, or you have suggestions, to improve this or the other documents appearing in the website, e.g. addition of new Sections and/or texts please send your suggestions to European ommission (for the attention of Mr.. Rossi) (for address see document EU and ational Authorities ). The ommission may insert these proposals in an updated version of the Practical Guide. 2

3 Synoptic document TABE OF OTETS Appendix and annexes ontent ast Update ote for reader Table of contents EWS Explanatory ote Page Appendix 1 General information or abbreviations of the main terms Appendix 2 Definition of SF lists Appendix 3 otes related to the column Restrictions and/or Specifications Table Status of the substances

4 Synoptic document EWS Warning The changes to the previous version of 2002 are indicated in the document in Bold and Italic characters. If you notice a mistake, please inform as soon as possible Mr. Rossi by uigi.rossi@cec.eu.int or by fax: ). 1. Any information concerning the SF evaluation should be addressed to the Secretary of the SF, Mr T. Hallas-Møller ( torben.hallas-moller@cec.eu.int) (see EU and ational Authorities document). 2. A recommendation has been introduced to consult also the website of DG SAO ( in order to know the results of the last meetings, held after the date of the update of the Synoptic document. 3 The meaning of some numbers or asterisks, which appear in the field RESTRITIOS AD/OR SPEIFIATIOS, is explained in Appendix 3. 4

5 Synoptic document EXAATORY OTE 1. This document summarises the ommunity situation and the Scientific ommittee on Food (SF) evaluations of the listed substances, which have been notified in view of their use in plastics materials intended to come into contact with foodstuffs. It contains all the monomers and additives (see an explanation of the terms in the appendix 1 and 2) notified to the European ommission and examined or which are being examined by SF until 31 December Even if a certain number of substances that are used only in surface coatings appear in this document, this document should not be considered the appropriate document to examine the legal situation of surface coatings. In fact at this moment surface coatings are excluded through the field of application of Directive 2002/72/E and therefore, from a legal point of view, the national legislation applies. 2. In principle, this document should not contain aids to polymerisation, colorants, inks and adhesives, although some appear. The list of solvents should be considered largely incomplete, because it remains under discussion whether or not it should be included in the additive list. Moreover, it must be stressed that the substances appearing in this document shall not be considered, at this stage, as the only monomers and additives legally used at ommunity level because the process of harmonisation of the national lists is ongoing. To know whether or not a substance, which does not appear in the ommunity directives, is authorised in the Member States, it is necessary to examine national laws or to consult the national authorities, whose address can be found in the document EU and ational Authorities. In conclusion this document should be considered as a working document and not as a legal or binding document, and, therefore, it may be subject to relevant modifications (integration, deletion and changes). 3. The ommission services intend to include definitively in the future ommunity lists, if any, only the substances classified by SF into lists 0-4. It is planned that the date when the list of additives (see definition later) becomes a positive list is fixed before 31 December The persons interested to a substance classified into SF lists 6-9, are invited to submit as soon as possible and not later 31 December 2004 the data requested by SF following the recommendations of ote for Guidance, included in the website. For further information on the list of additives see "Practical Guide", hapter I, Section 3? Paragraph At this stage, the ommission services are unable to specify whether the list will be extended to aids to polymerisation ("substances which directly influence the formation of polymers"), colorants, solvents, inks and adhesives. Therefore any extrapolation of the list to these substances is premature. Moreover, the ommission services can only add a) that the discussion on the type of rules to be applied to these substances will start after the ommunity lists for monomers and additives for plastics and coatings are adopted and b) that they are unable to specify any date on this matter. 5

6 Synoptic document 5. In principle the ommission services intend to update this document at the beginning of each year or when the relevant number of changes to be made justify an update (e.g. adoption of a Directive or of a report of the SF). When an update of the document is issued by Internet, the column 3 Update of the document is changed too in the homepage of the E-JR website. In order to know the last evaluations of the substances, see also the website of DG Health & onsumer Protection ( Any information concerning the SF evaluation should be addressed to the Secretary of the SF, Mr T. Hallas-Møller ( torben.hallas-moller@cec.eu.int) (see EU and ational Authorities document). 6

7 Synoptic document APPEDIX 1 GEERA IFORIOS OR ABBREVIATIOS OF THE MAI TERMS USED I THIS DOUMET Monomers and other starting substances Monomer and other starting substance", means any substance used in the manufacture of a macromolecule, which constitutes the repeating unit of a polymer chain or polymer network of any substance used in the manufacture of a plastic for food contact application. It also includes substances used to modify existing natural or synthetic macromolecular substances. According to Directive 2002/72/E, Annex 2, paragraph 1, the following substances are included in this definition: "- substances undergoing polymerisation, which include polycondensation, polyaddition or any other similar process, to manufacture macromolecules; - natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesise them are not included in the list; - substances used to modify existing natural or synthetic macromolecular substances." Although the definition and the examples seem very precise, some difficulties arise in the identification of "monomers and other starting substances" in practice. Therefore, it is recommended to read carefully the explanation given in Practical Guide, hapter I, Section 3, paragraph 2. Additives See also paragraph 3 of the explanatory note of this document. The list set out in the Table shall contain all the other substances not included in the definition of monomers and other starting substances and not included in the definition of aids to polymerisation (see below). Therefore this list shall include: a) substances which are incorporated into plastics to achieve a technical effect in the finished product; they are intended to be present in the finished articles ("additive"); b) substances used to provide a suitable medium in which polymerisation occurs or substances which directly influence the formation of polymers (conventionally these substances will called "polymer production aids") 7

8 Synoptic document Therefore this list will include for example the following categories of substances: "ategory I" - antifoaming agents - antiskinning agents - antioxidants - antistatic agents - driers - emulsifiers - fillers - flame retardants - foaming agents - hardening agents - impact modifiers - lubricants - miscellaneous additives - optical brighteners - plasticizers - preservatives - protective colloids - reinforcements - release agents - solvents (see paragraph 2 of the Explanatory ote) - stabilizers - thickeners - UV absorbers "ategory II" Polymer production aids - anti-foam reagents/de-gassing agents - blowing agents - buffering agents - build-up suppressants - dispersing aids - emulsifiers - flow control agents 8

9 Synoptic document - nucleating agents - ph regulators - solvents (see paragraph 2 of the Explanatory ote) - surfactants - suspension agents - stabilisers - thickening agents - water treatment reagents "ategory III" Aids to polymerisation They are "Substances which directly influence the formation of polymers" - accelerators - catalysts - catalyst de-activators - catalyst supports - catalyst modifiers - chain scission reagents - chain transfer or extending agents - chain stop reagents - cross-linking agents - initiators and promoters - molecular weight regulators - polymerization inhibitors - redox agents 9

10 EXAATIO OF THE OUMS Synoptic document A short explanation of the fields and of some abbreviations is given below. olumn 1 ("REF..") This contains the substance reference numbers. onventionally the following numbers have been assigned: Monomers: Additives: >30000 A substance listed as a monomer as well as an additive will be assigned two different REF.. numbers. In some cases, a cross-reference of the REF.. is inserted in order to find a substance having a synonym, commonly used. olumn 2 ("..") This contains the (hemical Abstracts Service) registry number, if any. If the substance is a mixture of substances, the number refers to the mixture. Where an indent has been placed in the column, it means that a research for. has been made, but that the result was negative. If the result of the search was found to be doubtful or that the research has not yet been made, a question mark appears in the column. Where there is inconsistency between the number and the chemical name, the chemical name shall take precedence over the number. If there is inconsistency between the number reported in EIES and the one in the -Register, the -number in the -Register shall apply. olumn 3 ("AME") This contains the chemical name attributed by the ommission services In some cases, a cross-reference of the REF.. is inserted in order to find a substance having a synonym, commonly used (see olumn 4) olumn 4 ("SYOIM") This contains the REF.. of a substance being a synonym, commonly used. olumn 5 ("") This indicates the Directive in which the substance is dealt with. The following abbreviations appear in this column: A0 = Directive 90/128/EE (Section A) B0 = Directive 90/128/EE (Section B) A1/B1 = 1 st amendment of Directive 90/128/EE Ac= Substances classified into SF lists 0-4 but not introduced in plastic directive because they are requested only for surface coatings Ax = Substances classified into SF lists 0-4 (Ax) but not introduced in plastic directive because they are not monomer or additives as defined in Directive 2002/72/E 10

11 Bx = Substances classified into SF lists 6-9 Synoptic document D = This letter indicates that the substance was considered by industry as "basic polymer" and therefore is not obligatory its listing if the starting substances are listed in Directive 2002/72/E Only the monomers and additives which are mentioned in the other document "EU SUBSTAES" in this website are considered substances approved at EU level. The other appearing in the table below are substances which likely have been approved at national level but which will not be included in the EU lists if the data requested by the SF are not supplied on time (see also paragraph 3 of the explanatory note of this document) olumn 6 ("SF_") This contains, before the stroke, the number of the list in which the substance is classified by the SF or by SF-WG FM. The meaning of the number or other abbreviations, which appear in this column, are described in Appendix 2 or later under Other abbreviations. olumn 7 ("SF OPIIO") This contains the opinion of the SF updated to 4 December As from September 2002, the SF changed the format of the opinions. A more extensive and detailed text summarises the historical background of the substances as well as the assessment given by the SF. Therefore, it has been decided to link the substance directly with the SF opinion published on Internet and no longer to repeat all the content of the SF evaluation. olumn 8 ("RESTRITIOS AD/OR SPEIFIATIOS") This contains the restrictions and/or specifications for the use of the substance set by the SF, as appearing in the Directive 2002/72/E. See also Appendix 3 olumn 9 ("_") The sign means that the substance was requested for plastics. olumn 10 ("_") The sign means that the substance was requested for coatings. Other abbreviations which may appear in the Table Ac ADI D Substances which can be authorised only for coatings Acceptable Daily Intake Deleted. There are several reasons why a substance is deleted. For example: a) The substance appears under another more appropriate name b) The substance is no longer requested by the petitioner c) The individual substance can be covered under a generic name d) The generic name has been deleted because the substances have been introduced individually D Deleted because considered as basic polymer. 11

12 Synoptic document Basic polymers means any polymeric substance, such as plastic or polymer, which is capable of functioning as the main structural component of finished materials and articles. They are not listed if their monomers are listed and they comply with Article 2 of Framework Directive DET D FP FS O S P QM QMA QM (T) SM SM (T) TDI W Detectable imit of detection Finished product (= material or article in finished state) Food simulants Isocyanate moiety ot specified in the field SF_ means Postponed. If a substance was already evaluated in the past, P clarifies that the classification is not longer valable pending a re-evaluation of the substance. Maximum permitted quantity of the "residual" substance in the material or article maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm² of the surface in contact with foodstuffs (QMA). The value is derived from the SM by assuming a) that the substance migrates completely (100 % of migration) and b) S/V report equal 6 dm²/1 liter Maximum permitted quantity of the "residual" substance in the material or article expressed as total of moiety/ substance(s) indicated Specific migration limit in foods or in food simulant Specific migration limit in foods or in food simulant expressed as total of moiety/substance(s) indicated. The number between brackets which appears after the restriction refers to the otes appearing in Annex VI of Directive 2002/72/E. Tolerable Daily Intake (this is a concept equivalent to the ADI, but applicable only to the packaging sector and not to food additives). when it appears in column "SF_", it refers to a "new substance". If it is alone, it means that the substance is not yet evaluated. If it is followed by a number, this number indicates the SF-."? Means that there is a doubt on the information given 12

13 Synoptic document APPEDIX 2 DEFIITIO OF THE SF ISTS Substances for which the ommittee was able to express an opinion ist 0 Substances, e.g. foods, which may be used in the production of plastic materials and articles, e.g. food ingredients and certain substances known from the intermediate metabolism in man and for which an ADI need not be established for this purpose. ist 1 Substances, e.g. food additives, for which an ADI (=Acceptable Daily Intake), a t-adi (=temporary ADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum Tolerable Daily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" has been established by this ommittee or by JEFA. ist 2 Substances for which a TDI or a t-tdi has been established by this ommittee. ist 3 Substances for which an ADI or a TDI could not be established, but where the present use could be accepted. Some of these substances are self-limiting because of their organoleptic properties or are volatile and therefore unlikely to be present in the finished product. For other substances with very low migration, a TDI has not been set, but the maximum level to be used in any packaging material or a specific limit of migration is stated. This is because the available toxicological data would give a TDI which allows that a specific limit of migration or a composition limit could be fixed at levels very much higher than the maximum likely intakes arising from present uses of the additive. IST 4 (for monomers) Section 4A Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method. Section 4B Substances for which an ADI or TDI could not be established, but which could be used if the levels of monomer residues in materials and articles intended to come into contact with foodstuffs are reduced as much as possible. IST 4 (for additives) 13

14 Synoptic document Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method. ist 5 Substances which should not be used. ist 6 Substances for which there exist suspicions about their toxicity and for which data is lacking or is insufficient. The allocation of substances to this list is mainly based upon similarity of structure with that of chemical substances already evaluated or known to have functional groups that indicate carcinogenic or other severe toxic properties. Section 6A: Substances suspected to have carcinogenic properties. These substances should not be detectable in foods or in food simulants by an appropriate sensitive method for each substance. Section 6B: Substances suspected to have toxic properties (other than carcinogenic). Restrictions may be indicated. ist 7 Substances for which some toxicological data exist, but for which an ADI or a TDI could not be established. The required additional information should be furnished. ist 8 Substances for which no or only scanty and inadequate data was available. ist 9 Substances and groups of substances which could not be evaluated due to lack of specifications (substances) or to lack of adequate description (groups of substances). Groups of substances should be replaced, where possible, by individual substances actually in use. Polymers for which the data on identity specified in "SF Guidelines" are not available. ist W "Waiting list". Substances not yet included in the ommunity lists, as they should be considered "new" substances, i.e. substances never approved at national level. These substances cannot be included in the ommunity lists, lacking the data requested by the ommittee. 14

15 Synoptic document ist W7 Substances for which some toxicological data exists, but for which an ADI or a TDI could not be established. The required additional information should be furnished. ist W8 Substances for which no or only scanty and inadequate data was available. ist W9 Substances and groups of substances which could not be evaluated due to lack of specifications (substances) or to lack of an adequate description (groups of substances). 15

16 Synoptic document APPEDIX 3 OTES REATED TO THE OUM RESTRITIOS AD/OR SPEIFIATIOS (1) Warning: there is a risk that the SM could be exceeded in fatty food simulants. (2) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. os: and (3) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. os: 15760, 16990, 47680, and (4) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. os: 19540, and (5) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. os: 14200, and (6) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. os: and (7) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 30080, 42320, 45195, 45200, 53610, 81760, and (8) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os:, 42400, 64320, 73040, 85760, 85840, and (9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EE. (10) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 30180, 40980, 63200, 65120, 65200, 65280, 65360, and (11) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 45200, 64320, and (12) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 36720, 36800, 36840, and

17 Synoptic document (13) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (14) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 44960, 68078, and (15) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 15970, 48640, 48720, 48880, 61280, and (16) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 49600, and (17) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, and (18) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 67600, and (19) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 60400, and (20) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (21) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (22) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (23) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: 13620, 36840, and (24) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (25) SM(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. os: and (26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as Ref. os: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, and

18 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Abietic acid A0 2 Group TDI: 1 mg/kg b.w. 90-day and 2-year oral rat studies. (Ind Bio Test, 1962). (SF, 17th Report, 1986) Acetaldehyde A0/A5 2 Group TDI = 0.1 mg/kg b.w. (calculated SM(T) = 6 mg/kg (2) as acetaldehyde (including and 23920) out16_en.html Toxicity profiles similar to methaldehyde. A 2-year oral rat study and a 3-generation oral rat study including teratogenicity with methamethaldehide. The reports on nasal carcinogenicity after inhalation were considered without relevance for effects from oral intake of smaller doses. (adopted at 113rd SF meeting)(17-18 September 1998) Acetic acid Same A0 1 Group ADI: not specified. (SF, 25th Series, 1990) Acetic acid, vinyl ester A0 2 TDI: 0.2 mg/kg b.w. 90-day oral studies and metabolism studies in mice and rats, teratogenicity studies in rats and several mutagenicity studies negative. (Hazleton: /4 January 1980; /11-14 and /6 & 7). SM = 12 mg/kg Acetic anhydride Same A0 2 Group TDI: included in the ADI not specified for acetic acid. (SF, 25th Series, 1990) Acetoguanamine Same B0/D Acetophenone 8 18

19 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS alpha-acetoxystyrene B1/D4 6A beta-acetoxystyrene B1/D4 6A p-(acetylamino)benzoic acid B0/D1 8 SF_ist 8 eeded data or information: Data according to the new SF- Guidelines. See SF evaluation in the website: out181_en.pdf Acetylene A0 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (IOSH, riteria for a recommended standard, HEW Publ. n ) Acids, aliphatic and cyclic, mono- and polycarboxylic, allyl esters Acids, aliphatic and cyclic, mono- and polycarboxylic, crotonyl esters Acids, aliphatic and cyclic, mono- and polycarboxylic, methallyl esters Acids, aliphatic and cyclic, mono- and polycarboxylic, vinyl esters Acids, aliphatic, dicarboxylic (3-18), diallyl esters Acids, aliphatic, dicarboxylic (3-18), divinyl esters Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric B0/D1 9 19

20 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acids, aliphatic, dicarboxylic (3-12), esters with alcohols, unsaturated (3-18) Acids, aliphatic, dicarboxylic, linear (6-12) Acids, aliphatic, dicarboxylic, linear (2-12), methyl esters Acids, aliphatic, dicarboxylic, saturated (4-18) Acids, aliphatic, dicarboxylic, saturated (4-22) Acids, aliphatic, dicarboxylic, saturated, esters with polypropyleneglycol Acids, aliphatic, dicarboxylic, unsaturated (4-12) Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol Acids, aliphatic, dicarboxylic, unsaturated (4-12), omegasulphoalkyl(2-6) diester Acids, aliphatic, dicarboxylic, unsaturated (4-12), omegasulphoalkyl(2-6) esters of monoalkyl(1-18) esters B0/D B0/D B0/D1 9 B0/D1 9 B0/D

21 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acids, aliphatic, mono- and dicarboxylic (2-20), vinyl esters Acids, aliphatic, monocarboxylic, branched (8-20) Acids, aliphatic, monocarboxylic (3-12), esters with alcohols, unsaturated (3-18) Acids, aliphatic, monocarboxylic, saturated (2-24) Acids, aliphatic, monocarboxylic, unsaturated (3-24) Acids, aliphatic, monocarboxylic, unsaturated (3-8), esters with alcohols, aliphatic, monohydric, saturated (2-12) Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol Acids, aliphatic, monocarboxylic, unsaturated (3-18), omegasulphoalkyl(2-6) esters Acids, aliphatic, monocarboxylic (2-20), vinyl esters Acids, aliphatic, mono- and polycarboxylic (1-18) Acids, aliphatic, mono- and polycarboxylic (3-12), esters with alcohols, aliphatic, monohydric (1- B0/D1 9 9 B0/D1 9 B0/D4 9 B0/D4 9 B0/D1 9 B0/D

22 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS 18) Acids, aliphatic, mono- and polycarboxylic (3-12), esters with alkyl(8-18)arylpoly (ethylene- and/or propylene- and/or butyleneglycol) (aryl = benzene or naphthalene) Acids, aliphatic, mono- and polycarboxylic (3-12), esters with alkyl(8-18)poly(ethylene- and/or propylene- and/or butyleneglycol) Acids, aliphatic, mono- and polycarboxylic (3-12), esters with cyclohexanol Acids, aliphatic, mono- and polycarboxylic (3-12), esters with ether alcohols (2-20) Acids, aliphatic, mono- and polycarboxylic (3-12), esters with poly(ethylene- and/or propylene- and/or butyleneglycol) Acids, aliphatic, mono- and polycarboxylic (3-12), monoesters with butanediol Acids, aliphatic, mono- and polycarboxylic (3-12) monoesters with ethyleneglycol Acids, aliphatic, mono- and polycarboxylic (3-12), monoesters with propanediol

23 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS 10595? Acids aliphatic, saturated(10), vinyl esters Acids, fatty, above Acids, fatty, dimers and trimers /1 - Acids, fatty, saturated(6-18) D 10599/50? Acids, fatty, saturated(8) /53? Acids, fatty, saturated(9) /56? Acids, fatty, saturated(10) /70? Acids, fatty, unsaturated(18) B1/D /73? Acids, fatty, unsaturated(20) /76? Acids, fatty, unsaturated(22) /79? Acids, fatty, unsaturated(24) / Acids, fatty, unsaturated(18), dimers Same /90A and /91 B1/D2 D 10599/90 A Acids, fatty, unsaturated (18), dimers, distilled Same /90 and /91 B2/B out140_en.pdf Group restriction: 0.05 mg/kg of food (for 10599/90A-10599/ /92A and 10599/93). Remark for ommission: only a method for residual content is available. A QMA-limit is applicable. 23

24 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS 10599/ Acids, fatty, unsaturated (18), dimers, non distilled Same /90 and /90A See SF evaluation in the website: outcome_en.html#opinions(sf/s/pm/ GE/M89) B2/B6 3 Same references as 10599/90A. out140_en.pdf 10599/ Acids, fatty, unsaturated(18), dimers, hydrogenated Same /92A, /93 and B1/D2 D 10599/92 A Acids, fatty, unsaturated (18), dimers, hydrogenated, distilled Same /92,10 599/9 3 and B2/B6 3 Same references as 10599/90A. out140_en.pdf 10599/ Acids, fatty, unsaturated (18), dimers, hydrogenated, non distilled Same /92,10 599/9 2A, B2/B6 3 Same references as 10599/90A. out140_en.pdf Acids, linear, with an even number of carbon atoms (8-22), and the dimers and trimers of the unsaturated acids Aconitic acid Same B0/D2 D Aconitic acid, methyl esters 9 24

25 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylamide B0/A1 4A eurotoxic for all 6 animal species tested. Teratogenic in rats. Genotoxic in several short term tests and carcinogenic in rats. (RIVM doc. March 1991) Acrylamido-2-methylpropanesulphonic acid SM = D (D = 0.01 mg/kg) B0/A3 3 R = 0.05 mg/kg of food. SM = 0.05 mg/kg Available: Migration data and mutagenicity tests. onsidered nongenotoxic based on the available studies (S/PM/2083) Acrylic acid A0 2 Group t-tdi: 0.1 mg/kg b.w. pending results of ongoing teratogenicity studies on acrylic acid. Available: a 90-day oral rat study, an oral reproduction study, 2- year oral rat and dog studies with acrylic acid and an oral teratogenicity study in rats with ethyl acrylate, 3-year oral rat and dog studies with acrylic acid, ethylene glycol monoester. (TP; Union arbide report (26 August 1980) and (22 August 1980); RIVM report (June 1984); report Dow, 1967 and 1967; RIVM report ) Acrylic acid, allyl ester B0/D2 6A Acrylic acid, benzyl ester B0/A2 2 Group TDI: 0.1 mg/kg bw (as acrylic acid). Hydrolysis (complete) data allow to allocate the same TDI as acrylic acid Acrylic acid, 4-tert-butylcyclohexyl ester B1/D Acrylic acid, n-butyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, sec-butyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid. 25

26 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, tert-butyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, 2-chloroethyl ester B0/D Acrylic acid, cyclohexylaminoethyl ester B0/D Acrylic acid, cyclohexyl ester B0/D4 8 Available: hydrolysis data, but hydrolysis is not complete Acrylic acid, cyclopentyl ester B0/D Acrylic acid, decyl ester B0/D2 7 eeded: hydrolysis data Acrylic acid,,-dialkyl(1-4)aminoalkyl(2-8) ester Acrylic acid, dicyclopentadienyl ester B1/A5 3 R = 0.05 mg/kg of food. Available: Migration by worst case calculation < 50 ppb, 3 mutagenicity tests negative. QMA = 0.05 mg/6 dm² (RIVM/TO/ISS SDS S/PM/2743, January 1996) Acrylic acid, dicyclopentenyl ester B1/D Acrylic acid, diester with 2,2-bis(4- hydroxy phenyl)propane bis(2- hydroxyethyl) ether B1/D Acrylic acid, diester with 1,3-butanediol B0/D Acrylic acid, diester with 1,4-butanediol B0/D Acrylic acid, diester with diethyleneglycol Acrylic acid, diester with 2,2-dimethyl- 1,3-propanediol B0/D

27 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, diester with dipropyleneglycol Acrylic acid, diester with ethyleneglycol B0/D Acrylic acid, diester with 1,6-hexanediol B0/D Acrylic acid, diester with polyethyleneglycol Acrylic acid, diester with tetraethyleneglycol Acrylic acid, diester with triethyleneglycol Acrylic acid, diester with and tripropyleneglycol 66-5 B0/D2 8 B1/D4 8 8 B1/D Acrylic acid, 2-(diethylamino)ethyl ester B0/D Acrylic acid, 2-(dimethylamino)ethyl ester B0/D2 7 eeded: hydrolysis data Acrylic acid, dodecyl ester B1/A5 3 R = 0.05 mg/kg of food. Available: Migration data, 3 (negative) mutagenicity studies. (ISS/TO SDS, March 1997 = S/PM/2996/11245) Acrylic acid, 2,3-epoxypropyl ester Same Remark: Since high migration into fat has been demonstrated the WG recommends that the ommission take the necessary measures so that the restriction proposed is not exceeded. SM = 0.05 mg/kg (1) B0/D2 6A 27

28 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (1-21) Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (4-18) Acrylic acid, esters with alcohols, aliphatic, polyhydric Acrylic acid, esters with alcohols, aliphatic, polyhydric (2-21) 11365? Acrylic acid, ester with 2,2-dimethyl-1,3- propanediol B0/D1 9 B0/D1 9 9 B0/D1 9 D Acrylic acid, esters with etheralcohols B0/D Acrylic acid, esters with etheralcohols, aliphatic, monohydric, saturated (1-21) Acrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (1-18) 11425? Acrylic acid, ester with methoxydiethylene- glycol Acrylic acid, ester with methoxypolyethyleneglycol Acrylic acid, ester with trimethylethanolammonium chloride D B0/D B0/D Acrylic acid, ethyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). 28

29 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, 2-ethylhexyl ester B0/B6/ B8 See references for acrylic acid. 7 Available: 18% hydrolysis in simulated saliva; specific migration in 3% acetic acid, 15% ethanol and 95% ethanol (10 days at 40 ) < 0.05 mg/kg into food; two gene mutation assays in bacteria (one negative (publication) and one inadequate); limited chromosomal aberration assay in cultured mammalian cells (publication); four gene mutation assays in cultured mammalian cells (one equivocal (publication); one inconclusive (publication); one inadequate and one limited); in vivo chromosomal aberration assay (negative); in vitro micronucleus assay (negative (publication)); limited in vitro UDS assay; inadequate SE assay; limited mammalian cell transformation assay; limited acute and subacute toxicity studies; two subchronic inhalation toxicity studies (one of which was limited) (OE established but not relevant); three dermal long-term toxicity/carcinogenicity studies (one of which was limited) (no OE established); limited data on absorption, distribution, metabolism and excretion; four limited sensitisation studies; limited eye irritation study in rabbits. eeded: in vivo UDS assay. RIVM/UK/TO SDS, February 2000 = S/PM/3270 REV.II/ (Adopted at the 121 SF meeting (20 June 2000)) out62_en.pdf Acrylic acid, hydroxyethyl ester Same A0 See "Acrylic acid, monoester with 29

30 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS ethyleneglycol" Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester) B1/D4 7 eeded: hydrolysis data Acrylic acid, 2-hydroxypropyl ester B0/A6 3 R = 0.05 mg/kg of food (for the mixture). Based on the reduced core set of toxicological data according to the migration level, see Appendix 2 Available: calculation of worst case migration is < 0.05 mg/kg of food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative). RIVM/ISS/TO SDS, July 2000 = S/PM/3117 REV. I/ Remark for ommission: - Only a residual Q method is available. A QMA of 50 ug/6 dm2 is proposed. QMA = 0.05 mg/6 dm² (Adopted at the 126th SF meeting, 28 February 2001) out84_en.pdf Acrylic acid, 3-hydroxypropyl ester B1/D Acrylic acid, isobornyl ester B0/D Acrylic acid, isobutyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, isodecyl ester B0/D4 8 30

31 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, isooctadecyl ester Acrylic acid, isooctyl ester B0/D Acrylic acid, isopropyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, 2-methoxyethyl ester B1/D4 6B Acrylic acid, methyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, monoester with 1,3- butanediol B0/D4 7 eeded: hydrolysis data Acrylic acid, monoester with 1,4- butanediol Acrylic acid, monoester with diethyleneglycol Acrylic acid, monoester with 2,2- dimethyl- 1,3-propanediol Acrylic acid, monoester with ethyleneglycol Acrylic acid, monoester with 1,6- hexanediol 11845? Acrylic acid, monoester with pentapropyleneglycol Acrylic acid, monoester with polyethyleneglycol Acrylic acid, monoester with polypropyleneglycol Same B0/D4 8 B0/D4 7 eeded: hydrolysis data. 8 A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid. 8 7 eeded: hydrolysis data

32 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Acrylic acid, monoester with propyleneglycol B0/D Acrylic acid, octadecyl ester B1/D2 7 eeded: hydrolysis data Acrylic acid, n-octyl ester B0/A2 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). Hydrolysis (complete) data allow to allocate the same TDI as acrylic acid Acrylic acid, phenylaminoethyl ester B0/D Acrylic acid, phenyl ester B0/D1 7 eeded: hydrolysis data Acrylic acid, propyl ester A0 2 Group t-tdi: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid Acrylic acid, 2-sulphoethyl ester B0/D Acrylic acid, sulphopropyl ester B0/D Acrylic acid, triester with glycerol tris(2- hydroxypropyl) ether B1/D Acrylic acid, triester with pentaerythritol Acrylic acid, triester with 1,1,1- trimethylolpropane tris(2-hydroxyethyl) ether B1/D Acrylic acid, vinyl ester B0/D1 7 eeded: hydrolysis data Acrylonitrile A0 4A (SF, 13th Series, 1982). SM = D (D =0.020 mg/kg, analytical tolerance included) Adipic acid Same A0 1 ADI: 5 mg/kg b.w. (SF, 25th Series, 1990) Adipic acid,bis(3,4-6a 32

33 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS epoxycyclohexylmethyl) ester Adipic acid, diallyl ester Same B0/D4 6A Adipic acid, di-n-decyl ester Same Adipic acid, diisodecyl ester Same B0/D4 6B Group R: 0.05 mg/kg b.w. eeded: toxicological data depending on migration level (see SF guidelines) and, if migration exceeds mg/kg, peroxisome proliferation study, too. B0/D4 6B Group R: 0.05 mg/kg b.w. eeded: in first instance specifications and then on the specified substances toxicological data depending on migration level (see SF guidelines) and, if migration exceeds mg/kg, peroxisome proliferation studies too Adipic acid, dimethyl ester Same Adipic acid, di-n-octyl ester Same B Group R : 0.05 mg/kg b.w. eeded: toxicological data depending on migration level (see SF guidelines) and, if migration exceeds mg/kg, peroxisome proliferation study too. B0/D4 6B Group R: 0.05 mg/kg b.w. eeded: toxicological data depending on migration level (see SFguidelines) and, if migration exceeds mg/kg, peroxisome proliferation study too Adipic acid, divinyl ester B1/A5 3 R = 0.5% (w/w) as co-monomer. QM = 5 mg/kg in FP. For use only as comonomer. Hydrolysis data, inadequate. However residue level very low. (TO SDS ) Adipic anhydride B0/A1 2 Group TDI: 5 mg/kg b.w. Included in group ADI for adipic acid Albumin A Albumin, coagulated by formaldehyde A0 3 Though albumin is a food component, it has been modified by formaldehyde which is classified in list 3 in 17th Series, SF,

34 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Alcohols, aliphatic, monohydric, saturated (1-18) Alcohols, aliphatic, monohydric, saturated, primary, secondary or tertiary (4-22) B0/D4 7 eeded: actual use, 28-day oral study of one lower and one higher alcohol Alcohols, aliphatic, monohydric, saturated, linear, primary (4-22) Alcohols, aliphatic, monohydric, unsaturated (up to 18) Alcohols, aliphatic, polyhydric (up to 18) Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to 18) A day oral studies, metabolic and/or mutagenicity studies with some substances out of the group. B0/D1 9 B0/D1 9 B0/D Aldehydes (4) B0/D Aldehydes, aliphatic, saturated (1-6) Alkadienes B0/D Alkenes (up to 16) n-alkenes (up to 16) B0/D n-alkyl(1-6) amides of unsaturated aliphatic mono- and polycarboxylic acids (3-18) Alkyl(2-18)diethoxy(methyl)silane Alkyl(10-16)-2,3-epoxypropyl ethers Alkyl(12-14)-2,3-epoxypropyl ethers D 34

35 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Alkylphenols See also Alkyl(1-4)phenols (consisting of a mixture of mono, di, tri and tetra alkyl substituted phenols and up to 2% phenol) 5 Substance which should not be used. Available: inadequate migration data, acute toxicity data on several components of mixture. Evaluation is not possible from the data provided. Sources for the mixture mentioned do not exclude presence of toxic components. Quantitative ranges are lacking for many substances. (RIVM/TO SDS, February 1997 = S/PM/2993/12578) p-alkyl(4-9)phenols B0/D Allyl alcohol B0/D4 6A Allyl bis(hydroxymethyl)phenyl ether Allyl 2,3-epoxypropyl ether B0/D2 6A Allyl ethers of monohydric alcohols (1-18) Allyl ethers of polyhydric alcohols (2-12) Allyl ethers of mono-, di-, or trimethylolphenol Allyl (hydroxymethyl)phenyl ether Same (Allyloxy)benzyl alcohol Same D 6A 35

36 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Allyl phenyl ether 6A Allyl tris(hydroxymethyl)phenyl ether Amides made from 18-unsaturated fatty acid dimers and triethylenetetramine Amines, bis(hydrogenated tallow alkyl) oxydised D/Sa me Amines, coco alkyl D Aminoalkyl(2-8)-','-dialkyl(1-4)-acrylamide Aminoalkyl(2-8)-','-dialkyl(1-4)methacrylamide Amino-3-aminomethyl-3,5,5- trimethylcyclohexane Same B0/A1 2 t-tdi: 0.1 mg/kg b.w. Available: 13-week oral rat study, 2 negative mutagenicity studies. (RIVM summary data, April 1991)(S/PM/921). eeded: in-vitro chromosome aberration and gene mutation in mammalian cells. SM = 6 mg/kg Aminobenzoic acid B0/D4 8 SF_ist 8 eeded data or information: Data according to the new SF- Guidelines. See SF evaluation in the website: out181_en.pdf Aminocaproic acid B0/D omega-aminocarboxylic acids, aliphatic, linear (6-12) B0/D Aminododecanoic acid A5 3 R = 0.05 mg/kg of food. SM = 0.05 mg/kg Mutagenicity tests are negative and 36

37 AME SYO IM SF SF OPIIO RESTRITIOS AD/OR SPEIFIATIOS Aminoethanol Same and migration is low (less than 50 ppb). (RIVM/TO doc. S/PM/2162). A6 3 R = 0.05 mg/kg of food. SM = out62_en.pdf Available: migration data from multilayer bottle and residual content in polymer; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); in vitro cell transformation assay (negative); toxicology summary on reproductive toxicity; general toxicological overview on MEA (made by the applicant). RIVM/TO SDS, August 1999 = S/PM/3337/ Remark: substance evaluated only for the requested use of indirect contact with non-fatty food mg/kg. ot for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EE and for indirect food contact only, behind the PET layer Monoethanolamine Same and (Adopted at the 121 SF meeting (20 June 2000)) (2-Aminoethyl)-beta-alanine, sodium salt Same A6 3 R = 0.05 mg/kg of food out61_en.pdf SM = 0.05 mg/kg Available: specific migration in 3% acetic acid, 15% ethanol and 95% ethanol < 0.03 mg/kg food; gene mutation assay in bacteria (negative); 37