Document 3NG0RbbOzekoa7oNKOg2e2YMn

JUN-08-1992 11:20 LONZA INC. Research and Development 79 Route 22 East, P.O. Box 993 Annandale, NJ 06801 FROM LONZfi INC. R & 0 TO 92164476459 P.01 Fax Transmittal Form This Fax v/ffl be X will NOTbe confirmed by mall To: dcnun'ie Z); H/& A- Location: f (pOOcLri ck FAX: c4)fe- Date: TfZtJrgCC:______________________ From: Telephone: _ Sender FAX: ,(3fl8)J[30-JQ0- .(9flB)JZ3Drl5^6- Number of Pages: ^4 (Includiing this page) Ifallpages are not received properly, please contact sender. Subject:------- 21615002 JUN 8 '92 10:19 Telephone - 908-7301500, Mein Fox - 908-730-1546 A member of the A'L AlvSuissc-Lonza Group BFG15740 908 730 1546 PAGE.001 JUN-08-1992 11:21 FROM LONZA. INC. R 8, D COMMISSION OF THE EUROPEAN COMMUNITIES Directorate- General for Industrial Affairs and Internal Market Ill/C/1 TO 92164476459 P.02 CS/PM/t 021 III/3141/89-EN <Rev, 5) LR/LR Brussels, 1 August 1991 DRAFT SYNOPTIC DOCUMENT 6 on PLASTICS MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS (updated to 1 August 1991) NOTA BENE The amendments to the text of the previous version (Synoptic 4) are written in bold characters or underlined. Typed on (1 240 (Rossi) Fils'. 0iUP58\B3\EN3141A5.DOC JUN 8 '92 10:20 BFG15741 908 730 1546 PAGE.002 21615003 JUN-08-1992 11:21 FROM LONZFli INC. R & D 2 TO 92164476459 P.03 INDEX. Page EXPLANATORY NOTE.................................................................................................................3 ADDENDUM TO THE EXPLANATORY NOTE...............................................................................7 1 . Explanation of the columns................................................................... 7 2, Explanation of expressions or abbreviations used in the tables listed in alphabetical order............................. 15 3. Type of material or product............................................................... 18 <S, Type of plastics................................................................. 16 APPENDIX 1 TO THE ADDENDUM Guidelines about the data requested by SCF,,,.,.............................. 3 O APPENDIX 2 TO THE ADDENDUM Deadlines for the transmission of data requested by SCF............ SiA ANNEX 1 . ANNEX 1b ANNEX 2. ANNEX 3. Synoptic complete positive EEC list of monomers and other starting substances............ EEC positive list of biopolymers.... Synoptic provisional and incomplete EEC list of Aids to polymerization ("Substances which directly influence the formation of polymers, .........2 /i /i 6 Jle. v- MBTfl BENE The amendments to the text of the previous version (Synoptic 4) are written In bold characters or underlined. IN ANY CORRESPONDENCE WITH THE EEC SERVICES AND THE SCF ON A SUBSTANCE INCLUDED IN THIS DOCUMENT, IT IS ABSOLUTELY NECE5SARY TO FOLLOlil STRICTLY THE INSTRUCTIONS INDICATED IN THE DOCUMENT "NOTE FOR GUIDANCE OF APPLICANTS..," <111/3588/89 Final) AVAILABLE ON REQUEST TO THE FOLLOWING ADDRESS: Commission of the European Communities (for the attention of Mr GontlerlDIV, III/C/1 200, rue de la Loi Batiment NERV 2/22 0-1049 BRUSSELS Telephone: (02) 2355989 Telefax: (02) 2351735 Telex: 21877 COMEUR JUN 8 '92 10:20 BFG15742 908 730 1546 PAGE.003 JUN-0S-1992 11:21 FROM LONZfl, INC. R & D TO 92164476459 P.04 3 EXPLANATORY NOTE 1. The Commission of the European Communities ("CEC"> is in the process of completing the Community law in the sector of plastics materials, as laid down by Annex 1 to the Council Directive B9/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with fooostuffs (O.J. N, L 40, 11 February 19B9 (hereinafter called "new framework Directive"). In principle, it is provided that the final Community regulation will contain rules concerning the following aspects! a) a positive list of substances authorized; b) a global migration limit) c) the basic rules for testing migration (list of simulants, conditions far testing migration (time, temperature)); d> the criteria for purity of certain substances; e> the-methods of analysis; f) other. 2. Because or the complexity of the subject and the number of discrepancies between the national Laws, the CEC decided to proceed step by step, proposing for adoption Directives pn the specific aspects of the regulation. Six Directives have already been adopted in this sector: - 70/142/EEC concerning the limits for vinvl chloride monomer (VCM) (DJ n. L 44 of 15,02.1970) ; * B0/766/EEC concerning the determination of VCM in the finished products (OJ n.L 213 of U.DB.1980), 81/432/EEC concerning the determination of VCM in the foodstuffs (OJ n, 147 of 24.04,1981). - 82/711/EEC Directive on plastics "basic rules for testing migration'' (OJ n, L, 297 of 23,10.1982); 65/572/EEC Directive on plastics "list of simulants to be used for testing migration" (OJ n.L.372 of 31.12.1985). - 90/128/EEC Directive on plastics "monomer" (OJ n, L 128 of 21.3.1990 rectified by OJ n.349 of 13.12.90. 3. Other Directives are either being prepared or being planned. Such Directives will take the legal form of Commission Directives (adopted by a qualified majority (54/74 votes) by the Standing Committee for Food, according to the new procedure laid down in Article 3 of the new framework Directive), In principle they will consist of: a) a first modification of the Directive on monomers in order to: include "new" monomers amend the legal status of the listed monomers, if a re-evaluation of a substance makes it necessary. A draft is now reedy (111/3274/91 Rev.l) and is planned to be available for adoption before 31 December 1991. b) a modification of Directive 82/711/EEC in order to add the test conditions for high temperature contact and the use of microwave (planned for 1992)(doc, III/3278/91 Rev.l): c) an extension of the positive list of the adopted Directive on monomers in order to' include the monomers used to 21615005 JUN 8 '92 10:21 BFG15743 908 730 1546 PRGE.004 JUN-08-1992 li:22 FROM LONZAi INC. R & D TO 92164476459 P.05 * manufacture varnishes, lacquers, paints,including epoxy retin* as wall as the additives of the mentioned products (planned for the end of 1992). d) some Directives which will - codify, complete (e.g. purity criteria) and, in some cases, amend (e.g. basic rules for migration tests) the previously adopted Directives. NOTA BENE The problem of the official control of plastics materials and articles and the methods of analysis will be examined later, taking account of the development of Directive B9/397/EEC. At present there ere the following two initiatives: a) the European Committee for Normalization (CEN) is preparing methods of determination of the global migration and for controlling the quantitative restrictions on some monomers set out in Directive 9D/128/EEC; b) the Council of Europe is preparing a compilation of the methods actually available for the determination of specific migration In foods or foods simulants. For further information, please, contact Mr. Baum, Council of Europe, Partial Agreement, Division, BP 431 R6, F-67006 STRASBOURG, Cedex-France (phone: 8614961; fax, 8367057). 4, This-document is a working document containing the monomers (see Annex 1) and additives (see Annex 2) listed by the Commission services until 1 August 1991, In particular it contains: a) in Annex 1 the draft of a complete positive list of monomers for ell types of plastics (including varnishes and excluding only silicones), Therefore this list includes: - the monomers contained in the Directive; the "new" requested monomers; - monomers (as individual compound) derived from generic terms classified in list 9 by SCF and, therefore, destined to be deleted in the draft of first modification of Directive 90/128/EEC. These monomers can be recognised because in column "REMARKS" the abbreviation SI(PM/REF,N> appears. - all the monomers for varnishes (which now include epoxy resins). NOTA BENE. - This list does not contain the monomers for silicones, as these products will be considered in later stage. - This list does not contain the monomers notified by UK on 4 April 1991 (C5/PH/950) and on 9 July 1X91 (CS/PM/97B) as these substances were not accompanied by a technical dossier according to the "NOTE FOR GUIDANCE" or accompanied Py a documentation showing that these substances are included in a national positive list or in FDA before 31 December 1990," Also in this last case the substances will be included only provisionally waiting for a technical dossier, b) In Annex 1 bi6 the requested products obtained by means of 21615006 JUN 8 '92 10:21 BFG15744 908 730 1546 PAGE.005 JUN-08-1992 11:23 FROM LONZAi INC. R & D 5 TO 92164476459 P.06 bacterial fermentation and submitted for approval to CEC are listed) In principle the columns 2, 4, S and 12 are equal to columns 1,2,3 and 4 of the Oirective on monomers, In certain cases a difference can be noted as some monomers were re-evaluated by SCF after the adoption of tne Directive on monomers and the Commission services proposed to modify the current restrictions in order ta take account of the new evaluations. It has also to be noted that the list is presented in another format, which allows for listing the monomers in alphabetical and progressive PM/REF Number order and to provide supplementary information! c) in Annex 2 the draft of the updated list of additives, At present this list contains: ell the additives (according to the definition which appear in Annex 2) referring to the plastics regulated by the Directive 90/128/EEC) therefore it includes also all the polymers used as additives as the SCF recently) recommended that the technical dossiers, particularly the specifications for the identity) should be provided in order to evaluating them. - all the additives for epoxy resins (they are included under the column MAT_C>) NOTA BENE, This list does not yet contain: a) a large majority of additives for varnishes, They will be added in the next version according to the document in preparation at the Council of Europe) b) all the additives for silicones, as these products will be considered in later stage. N.B. In the document some Items appear such as "coatings", "epoxy resins", "silicones" which are intended to be deleted. They are introduced only for recording the documents (cs/pm/,.,) referring to them. 5, This document represents a working document and, therefore, it may be subject to modifications. However, it reflects with regard to. the substances included and to the restrictions going with a number of substances the present opinion of the Commission services. 6. This document is based on the previous document 1II/J141/B9-EN (Rev.4) (15 January 1991), modified to take account of: a) the requests on "new" monomers and additives received by the Commission services before the 1 August 1991 according to the "NOTE FOR GUIDANCE"; b) the results of the evaluations made by SCF during 1991 and their consequences on the EEC status of the compound) c) some of the new information submitted to the Commission by the Member States and by industry until the date of update) d> the new deadlines fixed according to the general rules set out in Appendix 1, 21615007 JUN 8 '92 10:22 BFG15745 908 730 1546 PAGE.006 JUN-08-1992 11:23 FROM LONZA, INC. RU 6 TO 92164476459 P. 07 7, The Commission services believe that they have considered all documents received before 1 August 1991. Any comment to this document should be addressed to the following address: COMMISSION OF THE EUROPEAN COMMUNITIES OG III {for the attention of Mr Rossi Luigi) 200, RUE DE LA LOI 1049 BRUSSELS tel. (00)(32) (2)23560EB/23549<9 telefay (00322)2301735 (use only this number!) telex 217877 COMEUR 21615008 JUN 8 '92 10:22 908 730 1546 PAGE. 007 JUN-08-1992 11=23 FROM LQNZA, INC. R & D 7 TO 92164476459 P.08 ADDENDUM TO THE EXPLANATORY NOTE INFORMATION OR ABBREVIATIONS INCLUDED IN THE COLUMN^ OF THE TABLE5 OF THE ANNEXES 1 and 2 OF THE SYNOPTIC DOCUMENT 1 EXPLANATION OF THE COLUMNS Column "U" If the column "U" appears in the document, the sign indicates that the "relevant" (not redactional) content of at least one column of the item has been modified not only with regards to the "synoptic" document III/3141/89 (rev.4) but also to consolidated SCF report on monomers (CS/PM/443) end SCF report Dn additives (CS/PM/<64). The modifications of documents C5/PM/1C22 and 1023 appear only in the corresponding documents e.g, CS/PM/1022 and 1023 although the sign + appears in synoptic document too, Column "PM/BEF, N." It contains the EEC packaging materials reference number of the substances on the list; conventionally the following numbers have been assigned: monomers i 10000-29999 additives: >30000 These numbers will be used not only in the Directive on plastics materials but also in Directives relating to other materials eg, paper, rubber, etc. A substance listed as monomer as well a* an additive will be assigned two different PM/REF numbers. In order to avoid frequent modification of the lists, a PM/REF_N, will only be assigned when the chemical or legislative status of that substances is clear for the CEC. IN CORRESPONDENCE WITH THE COMMISSION SERVICES AND THE SCF, THE PM/REF.N., IF ANY, THE CAS N., IF ANY AND THE CHEMICAL NAME (FOLLOWING THE RULES SET OUT IN THE EXPLANATION FOR COLUMN "NAME"), SHOULD ALWAYS BE MENTIONED. CORRESPONDENCE NOT INCLUDING SUCH NUMBERS COULD BE REJECTED. Column "COUNTRY" It contains the country(ies) which, in principle, authorlze(s) and/or useis) (at least for one of the products included in the field of application of the consolidated Directive) the substance(s) or a part of the substances included in the item. In a few cases SCF appears, It means that the SCF splits the substance requested by the countries Indicated in 2 substances. Because it is impossible to describe the complex national legal situation, the content of this column is not very precise. In order to know exactly how the legal system actually applies to a substance at natipnal level, it is imperative to refer to the national legislation, DK,H,IRL,L,P do not appear in column COUNTRY" Oecause these countries have no lists of substances authorized. There is no positive list for monomers in France, but admission of some particular monomers has been requested officially. Therefore F appears in the columns only for those monomers, Abbreviations used: B Belgium 0 Federal Republic of Germany DK Denmark 21615009 JUN 8 '92 10:23 BFG15747 908 730 1546 PAGE. 008 JUN-08-1992 11=24 FROM LONZfi> INC. R 8, D B TO 92164476459 E Spain F France H Greece I Italy IRL Zrelend L Luxembourg N Netherlands P Portugal UK United Kingdom Column "CAS N" It contains the CAS (Chemical Abstracts Service) registry number, if any) if the substance is a mixture of substances, the CAS number refers to the mixture. Where an indent has been placed in the column, it means that a research for CAS N, has been made, but that tne result was negative, If the result of the search was found to be doubtful a question nark was set to the result, If no CAS number or indent has been placed in the column it means that the research has not yet been made. Where there is inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is inconsistency between the CAS number reported in EINECS and the one in the CAS-Register, the CAS-number in the CAS-Register shall apply. P.09 Column "NABE" It contains the chemical name. In principle, the substances labelled with an asterisk are included in Section B of the Directive. For these substances the SCF recommends the requested data (see the SCF consolidated report on'monomers (C5/P(Vt022) as well as the one on additive CS/PM/1023) to be submitted in accordance I with the rules set out in the "NOTE FOR GUIDANCE OF APPLICANTS,," (111/3568/89 Final) and taking account of the deadlines laid down in Appendix 1, The data requested are set out in Appendix 2, In principle, the substances are listed according to their common name. The following general criteria have been applied) 1, The substances are listed in English version in alphabetical order with the following conventions) a) - special characters such as numerals, Greek letters (alpha, beta, epsilon, omega)) prefixes indicating substituted locations <m, o, p, C-,N-) stereochemicals (cis, trans) or other structural features In-, tert,, sec.)) plural as well as words or expressions which do not indicate a chemical structure e.g. "derived from..," or "substituted.." or "with..". are ignored) b) the following prefixes are considered to form part of the name) bis, cyclo, iso, and the numerals mono, di, tn, tetra, penta etc. In the main name they should be written in capitals. The following prefixes should be considered as additions and should not be printed in capitals in the main (>T0X9TZ ` JUN 8 '92 10=23 BFG15748 908 730 1546 PAGE. 009 JUN-0B-1992 11! 24 FROM LONZfl, INC. R & D TO 92164476459 P.10 9 name: ortho <o-), meta (m-), para (p->, alpha, beta, gemma etc. cis, trans, dextro (d-i, loevo (l->, normal (n->, N(=)ink to nitrogen atom), primary (prim.), secondary (sec.) and tertiary (tert.); c) generic terms describing aliphatic organic acids are indicated according to the following sequence! acids, aliphatic, mono- or polycarboxyl ic, saturated or unsaturated, linear or branched, (Cx-Cyi; d) generic terms describing aliphatic alcohols ere indicated according to the following sequence: alcohol, aliphatic, mono- or poiyhydric, saturated or unsaturated, linear or branched, primary or secondary or tertiary (Cx-Cy). e) esters of monohydric aliphatic alcohols are usually listed under the corresponding acids followed by the radical corresponding to the alcohol followed by the term "ester(s)"; f) esters of poiyhydric alcohols are usually listed under the corresponding acids followed by the terms ''esters with" and the name of the poiyhydric alcohol. In certain cases the esters are indicated, starting from the poiyhydric alcohols (eg. polyglycerol monostearate) g) polymeric additives are expressed in terms of the monomers which constitute them, in alphabetical order and separated by a hyphen, followed by the term "polymer" or "copolymer"; hi salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of an authorized acid, alcohol or phenol shall be automatically autorized. However, names containing for example "........................... acid(s), salts* appear in the lists if the corresponding free acid(s) is(are) not separately mentioned. In such cases the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc". Only in a few cases salts are listed starting by the metal; i) following common names are, for example, used: - arachidic acid - behenic acid - caprylie acid - lauric acid - myristic acid - oleic acid - palmitic acid - ricinoleic acid - stearic acid However the following systematic names of radicals have been retained: - n-dodecyl - n-hexadecyl instead of lauryl . " " cetyl 21615011 JUN B '92 10=24 BFG15749 908 730 1546 PftGE.01' JUN-0B-1992 11=25 FROM LONZR. INC. R & D 10 TO 92164476459 P.ll - n-octadecyl - n-tetradecyl - 2,3-epoxypropyl " " stearyl " " myristyl " " glycidyl Similarly the following systematic names of alcohols have been retained\ - n-dodecanol - n-hexadeeanol. - n-octadecanol - n-tetradecanol instead of lauryl alcohol " " cetyl alcohol " " stearyl alcohol * " myristyl alcohol Column "EEC l" It contain* the following abbreviation* which are useful for computer retrievali Ax* AO* A1* A1** A1S* substances allocated to Section A in one of the future EEC Directive ("Directive x*); substances allocated to Section A in EEC Directive 90/128/EEC; substances allocated to Section A in 1st modification of EEC Directive 90/12B/EEC; substances maintained in Section A in 1st modification of EEC Directive 90/128/EEC subject to amendment of their restriction) substances, derived by a generic deleted item, allocated to Section A in 1st modification of EEC Directive 90/12B/EEC; Bx* BD* B1 * 81** BIS* substances allocated to Section B in one of the future EEC Directive ("Directive x"); substances allocated to Section 6 in Oir'ective 90/128/EEC; substances allocated to Section B in 1st modification of Directive 90/128/EEC; substance* maintained in Section B in 1st modification of EEC Directive 90/128/EEC subject to amendment of their restriction; substances, derived by a generic deleted item, allocated to Section B In let modification of EEC Directive 90/128/EEC; BO/BI substance in section B in Directive 90/128/EEC and maintained in Section B in the first modification of the Directive 90/128/EEC; B0/B1"substance in section B in Directive 90/128/EEC and maintained with a different restriction in Section B of the first modification of the Directive 9Q/12B/EEC; Dx* substances deleted from the list in a future Directive ("Directive x"); D1* substances deleted in the first modification of the Directive 90/12B/EEC; 0= "new" substances never authorized (corresponding to substances in waiting list ("li"> in 5CF lists (see later) The criteria applied for the allocation into Section A and B is the followingi if the substance is classified by SCF in lists 0, 1, 2, 3, 4 it is allocated in Section A; if the substance is classified by SCF in lists i, 1, 8, 9 it is allocated in Section B, unless the substance is 21615012 JUN 8 '92 10=24 BFG15750 908 730 1546 PAGE.011 JUN-0B-1992 11:25 FROM LONZft. INC. R & D 11 TO 92164476459 P.12 not deleted- if you note inconsistency, please inform the Commission services. Co lemn.JlBES.TR ICTJJNS" In principle it may include; - the types of plastic materials for which the substance is authorized to be used (see abbreviations of the type of plastic later. Itlhere no Indication is given, the substance is authorized for use in all types of plastic materials)} - specific migration limit (SMI. or SML(T)) in food or in food Ii simulants (FS), unless it is specified otherwise} - the maximum quantity (QM or QM(T)) of substance permitted in the finished product (FP)j any other restriction specifically mentioned. The following expression "See PM/REF.N" may also appear. It means that the substance(s) mentioned in column "NAME" is(are) identical to the substance(s) mentioned in column "RESTRICTIONS" and that the preferred name in correspondence of which all the information is reported is that indicated in column "RESTRICTION, which will appear in extenso in Directive. If a substance appearing on the list as an Individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound. In principle, the relevant criteria U6ed by CEC for putting a restriction are the following; a) a substance contained in lists 4 or 6 of the 5CF reports or having an ADI (list 1) or a TDI (list 2) <1 mg/kg b.w., is subject to a quantitative restriction} b) a substance, used only in a few polymers (e.g., less than 3) which cannot be mixed with other polymers, could be subject to e restriction on use ("only for PVC")f c) a substance having an ADI or TDI less then 1 mg/kg b.w. will be subject to a specific migration limit in food or in food simulants equal to the value obtained by multiplying the ADI or TDI by 60. It is assumed that a man weights 60 kg and that he eats one kilo ! of foods in contact with the plastics containing always the i substance under reference} t d) a substance contained in list 4A (in the SCF report on monomers) or in list A (in the SCF report on additives) will be subject, in principle, to a limit of detection in food or in simulating liquids (FS) equal to 0.010 mg/kg (for some substances eg. acrylonitrile, methacrylonitrile, butadiene it was fixed a value D.020 mg/kg for taking account of the value of the reproducibility established in a collaborative test); e) a substance contained in list 6 A or in list 9 (in this last case only if the substance contains a group suspect to be carcinogenic ("allyl" "vinyl" "epQxy" etc.) will be subject, in principle, to a limit of detection in food or in food simulants equal to 0,050 mg/kg; f) a substance contained in list 3 or in list 66 and having a restriction expressed in a limit of migration will be subject to this limit of migration} g> a substance contained in list 3 or in list 68 and having a 21615013 JUN a '92 10:25 BFG15751 908 730 1546 PAGE.012 JUN-08-1992 11=26 FROM LONZfl- INC. R & D TO 92164476459 P.13 12 restriction expressed in mg/kg b.w. will be subject to a limit of migration obtained by multiplying the ADI or TDI by 60. In some cases, a specific migration limit could be deleted or replaced by a limit in the amount of residue <QM> in the finished product (FP). The reasons of this decision are indicated in the column ''REMARKS", when this column appear in the printed document. Column "REMARKS" In principle, this column (which will disappear in the Directive) may Include the information requested and/or other remarks (included as pro-memorla) made by CEC (eg. the type of polymer or material in which is used). For the meaning of the expressions used (for example Ex L9, or N1(PM/REF.N> or of the abbreviations, see later paragraph 2. Column "5CF l*' It contains the number of the list in which the substance is classified by the SCF or other abbreviations. The meaning of the number or other abbreviations which appears in this column is as following! M.5* i _ Substances 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 men and for which an ADI need not be established for this purpose. List 1 Substances for which an ADI, a temporary ADI (t-ADl), a MTD1, a PMTDI, or a PTWI or the classification "acceptable" has been established by this Committee or by JECFA, US*-?... Substances for which a TDI or t~TDI has been established by this Committee. LUttJL Substances for which an ADI or 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 is stated, This is because the available toxicological data would give a TDI very much higher than the maximum likely intakes arising from present uses of the additive. List 4 (for additives) Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into food or food simulants is not detectable by an agreed sensitive method, List 4 (for monomers)! List AA (for monomers) Idem list A for additives (see above! List AB (for monomers) Substances for which an ADI or TDI could not be established, but which could be used if the levels of monomers residues in materials and articles intended to come into contact with foodstuffs ere reduced, as much as possible Ust-S.. Substances which should not be used, List 6 Substances for which there exists suspicion about their toxicity and for 21615014 JUN 8 '92 10:25 BFG15752 908 730 1546 PAGE.013 JUN-08-1992 11!27 FROM LONZP, INC. R g, D 13 TO 92164476459 P.14 which data are lacking or are insufficient. Ltst.JA Substances suspected to have carcinogenic properties. These should not be detectable in foods or in food simulants by an appropriate sensitive method for each substance. LUt-Jifl Substances suspected to have toxic properties (other than carcinogenic), Restrictions may be indicated. List 7 Substances for which some toxicological data exist, but for which an ADI or TDI could not be established. The additional specified information should be furnished, LJst B Substances for which no or only scanty and inadequate data were available, Msl ?. Substances and groups of substances which could not be evaluated due to lack of specificity. These groups should be replaced by individual substances actually in use, tist.Jd. "Waiting list". Substances not yet included in the Community list ("New substances"). Besides the W a number indicating the SCF list (allocated on the basis of data available at the moment) may appear. Ust_e_ List of substances for which the evaluation is postponed as the SCF is preparing a toxicological sheet or by lack of time or for other reasons. l-igt.E*- List of <new> substances for which the evaluation is postponed as the SCF is preparing a toxicological sheet by lack of time or for other reasons. 41s* ...,jL When for a substance, already evaluated, new documentation is supplied, besides the number of the list .. may appear the letter P indicating that the substance is under re-evaluation. Column 'API" It contains the besides to the temporary. value in mg/kg b.w. of the ADI value indicates that the ADI or TDI. The asterisk or TOI attributed is Column "SCF N": It contains the following informations -M.. number of the meeting(s) of the working group "Packaging materials" of the SCF at which the item has been evaluatedj -R,. number of the Series of the SCF Report in which the opinion of the SCF on the item has been given or will given, R17* contains the evaluations for the monomers from the 1st until the 21 Meeting of the working group; R19* contains the evaluations for the monomers from the 22th until the 27th Meeting of the working group; R20= contains the evaluations for the monomers from the 2Bth until the 34th Meeting of the working group; Rx = contains the evaluations forthe additives from the 21st (18 April 1995) until the46th meeting (June 1991) of the working group "Packaging materials" of the SCF. The x will be replaced by the number of the report, when it will be published, probably in 1992. SI0ST9IZ JUN B '92 10=26 bFG15753 908 730 1546 PAGE.014 JUN-08-1992 11:27 FROM LONZfl, INC. R & D 1.4 TO 92164476459 P.15 Ry= containstheeveluationsforthemonomersf romthe3Stbnti lthe 46thmeetlng oftheSCFwg, Theywillbereplaced bythenumoer ofthereport,whenitwillbepublishedf probably ml 992-1993. Columns "DEADLINE1' See appendix 2, In principle the deadlines which appear in this column take account of the deadlines suggested by SCF in appendix 2). However they could differ in order to taking account also of other elements, for example; a) the need of avoiding too many deadlines; therefore a grouping of the deadlines in 30.6.199X or 31,12.199k is made; b) the possibility of submitting information in a time shorter of that indicated by SCf; c) the need of providing deadlines longer of those suggested by SCF, if there are valuable reasons for doing so. Normally this action will require a "quick11 consultation of the wg "Packaging Materials" of the SCF. It has to be noted that the application of the general rule described in Appendix 2, CASE II is not automatic when the substance is re-evaluated. For instance the deadline previously set out icould be maintained if the data to be supplied at the ~sri -zr i u-.' ... .. W7iT--------------------------- 1 . It has be noted that the deadlines indicated refer to the substance independently of the use of the substance (plastics, varnishes) and of the existence or not of a Directive adopted. That means that the substances for which'the deadline is exceeded and that are not "retained" <B1 in column EEC_U, could not appear longer or never appear in the Directive adopted or in future Directives, for example in the Directive which will include the additive list or in the Directive extending the field of application of Directive 90/128/EEC to varnishes, 2. Because a substance may be used as monomer and as additive, different deadlines can appear besides the same substance. 3. The deadlines suggested by industry in some letters for retaining the monomers in Section B are not accepted by CEC, if they are different from the general rules set out in appendix 2 of this document. In future only a letter of acceptation from CEC of the new delay proposed by applicants and addressed to them is a prove that the delay has been officially postponed. This explanation is necessary as the Commission services can not make a statement for each request transmitted to them. Column "DEADLINE 1" It contains the new precise deadline for retaining substance in Section B. Column "DEADLINE 2" It will contain the new precise deadline for submitting some of the data requested by SCF, Column "DEADLINE 3" 21615016 JUN 8 '92 10=26 BFG15754 908 730 1546 PAGE.015 JUN-08-1992 11 = 28 FROM L0N2A, INC. R & D 15 TO 92164476459 P.16 It will contain the new precise deadlines for submitting the remaining data requested by SCF, Column "ftOENPA" It contains the number of the meeting where the substance is planned to be examined. If appear S means that the evaluation of substance is suspended as the CC, after a first examination of SCF wg, has reteived or, at request of SCF wg, will receive new information. These substances will be included in the list of substances to be evaluated or re-evaluated by SCF. Column "CS PH" This column contains the progressive number of the document received or transmitted by the Commission which refers to the substance (see annexes of the minutes of the meetings of the SCF wg). If the number is followed by a stroke that means that all the documents listed at the left of the stroke have been examined by SCF, The letters for retaining a substance in Section 6 are indicated by an asterisk besides the reference number, although in some cases a technical dossier has been received. 2. EXPLANATION OF THE EXPRESSIONS OR ABBREVIATIONS .USED IN THE TABLE5 OR IN THE DOCUMENT. LISTED IN ALPHABETICAL ORDER N,B. The abbreviations used in the column "COUNTRY" are included in the explanatory note for this column (see paragraph 1 of the addendum) A AQ A1 A1 * A1S Ax AD ACC ALIPH. ADI AP B BO B1 B1* BIS Bx Bxi in the column EEC_l means Bubstance which will be put in the Directive in Section A (= substances authorized at EEC level) - in the column REMARKS means that the substance is . requested for general use) See explanation in point 1, under column EEC_1 "" Additive Acceptable for use Aliphatic Acceptable Daily Intake Aids to polymerization (which only include, conventionally, the substances which directly influence the formation of polymers, see Annex 3). means that the substance will be put in the Directive in Section 8 ('substances which may continue to be used at national level pending a decision on inclusion in Section A) if its deadline is not exceeded. See explanation in point 1, under column EC_1 " means substance for which an appropriate request (model letter 3 of the "Nate tor guidance") for retaining in Section B of the Directive 90/128/EEC has been transmitted to EEC services, These substances will appear in the Section B of ths future draft of x modification of the Directive 21615017 JUN 8 '92 10=27 BpG15755 908 730 1546 PAGE.016 JUN-08-1992 11:28 FROM LONZfi, INC. R & D TO 92164476458 P.17 16 90/1ZB/EEC, These substances coulcl be disappear if the results of the requested tests to be carried out are not supplied within the dates`which will appear in future in a new column "DEADLINE 2" (see appendix 1). C* Coatings (varnishes and lacquers, including epoxy resins) CEC Commission of the European Communities "COVERED BY..<PM/REF.NJ" Means that the substance(s) mentioned in column "NAME" is (are! included in the substance(s) mentioned in column "REMARKS". CYCL0AL1PH, Cycloaliphatic Dk See explanation in pont t, under "Column EEC_1" D1 "' D DEADLINE N.Dates within which the Commission should receive some specified information (see appendix 2) DET Detectable DL Limit of detection Ex L9 Substance for plastics destined to disappear from the list because replaced by individual compound (see explanation in par. t of the explanatory note), Ex L9* Substance used only for varnishes destined to disappear from the list because replaced by individual compound (see explanation in par,4 of the explanatory note). FP Finished product < material and article in finished state) F5 Food simulants gR Group Restriction. Restriction to be applied to all the substances indicated in the group as suggested by SCF in its reports. m Meta , M Monomer M. . Meeting (M followed by a number* see 5CF_M) MONOCARB. Monocarboxylic MONOH. Monohydric n Normal NCO Isocyanate moiety NEW SUBST. New substance. Substances requested to CEC for inclusion in the EEC positive list, but not yet authorized in at least one of the Member States of the European Communities (UK considered, in principle, "new" substance for "plastics" a substance not authorized in the USA before 31 December 1987 and for "varnishes" a substance not authorized in the USA before 31 December 1990), These substances will be evaluated by SCF only if the information requested by SCF in its Report (see "Note for guidance of applicants.." 111/3568/89-updated version) has been transmitted to CEC). These substances will appear in synoptic documents but not in the drafts of Directives. The Member States are invited to not authorize these substances until the SCF nas expressed its definitive opinion. NS Not specified o Ortho P Para P Substances for which the allocation in the columns "EC_L" or "5CF_L" is postponed P* <New> substances for which the allocation in EEC or SCF .t5_i5 postponed POL or Pol Polymep 21615018 JUN 8 '92 10:27 908 730 1546 PFGE.01? JUN-08-1992 11=29 FROM LONZA, INC. R *, D 17 TO 92164476459 P.1B 0M Maximum permitted quantity of the "residual" suDStahte in QM(T) the material or article Maximum permitted quantity of the "residual" substance in the material or article expressed as total of moyery substance(s) indicated Rx Number (not yet known! of the Report of the SCF on additive. Ry Number (not yet known) of the Report of the SCF on monomer, S Substancein suepens, Si(Pn/REf.NISubstance which replaces the generic term (PM/REF.N) classified by the SCF in 19. 52 Substance used only for varnishes which replaces the generic term (PM/REF.N) classified by the SCF in L9. "SAME ..(PM/REF.N) means that the substance(s) mentioned in column "NAME" is (are) identical to the substance(s) mentioned in column "RESTRICTIONS" SAT. SCF_L Saturated Number of the SCF list (seeexplanation in point 1) SCFiM Number of the meeting of the SCF'sworking group "Packaging Materials" in which the substance was Dr will be examined. M41 means 41st meeting Number. Meetings planned since M40. (M41 =19-20/VI 1/1990) | (M42*= 20-21/IX/1990); M43 15-16/X1 /I 990);(M64 20-21/I1/1991> <M45= 23-24/IV/1991);<M4= 10- 1 9/VI/199) ; (M47 10-11/IX/1991) ; (M4B = 1 3-U 1X/1994) "SIMILAR TO.,(PM/SCF.N) Means that the substancets) is(are) not identical to or covered by the other substance(s) mentioned but that there is a certain similarity which has to be taken into account in the final decision on the status of the substance; SML SML(T) Specific migration limit in foods or in food simulant Specific migration limit in, foods or in food simulant expressed as total of moiety/eubstancets) indicated. SML(Tp) Specific migration limit in foods or in food simulant for the group of substances having in COLUMN RESTRICTION the abbreviation SML(Tp); an explanation for these substances is given in CS/PM/95(5. "SPEC(I)" Specification on identity of the substance(s) are requested ) (See the chapter "Identity" of the new SCF guidelines included in "Note for guidance of applicants"); "SPEC(PI" Specification on purity of the substance(s) is (are) requested by SCF or by a Member State indicated in parentheses); "SPEC(U)'1 Specification on use of the substance are requested; is it a/monomer ("M") or additive ("A") - is it really used in plastic materials? What type? - is it technologically necessary (techn. nec.l? The Member State should provide by means of a letter addressed to CEC a report giving reasons for maintaining such substance(s) in the list. This letter must be provided to CEC as soon as possible and not later than 6 months after its apparition in synoptic document, After this period, the item could be deleted in the Directive; the final date will appear after the abbreviation; - Single or in combination with substances of the same chemical moiety or individually indicated. TO1 Tolerable Daily Intake (new concept established by SCF in 6T0SI9TZ JUN 8 '92 10=28 BFG15757 908 730 1546 PAGE.018 rMOt.Wig JUN-08-1992 11:30 FROM LONZFI, INC. R & D iy TO 92164476459 P.20 the definitions generally recognised, particularly to the Internatjontl Standard ISO,jS72. It is to be noted that an abbreviation for a Polymer refers both to the homopolymer and to various copolymers. ABS Acrylonitrile-butadiene-styrene CA Cellulose acetate CL Cellulose CP Cellulose propionate LCU Lignocellulose MABS Methyl methacrylete-acrylonitrile-butadiene-styrene MBS Methyl methacrylate-butadiene-styrene (IF Melamine-formaldehyde MUF Melamine-urea-formaldehyde NC Nitrocellulose PA Polyamides PAM Acrylic and methacrylic resins PAN Polyacrylonitrile PAR Polyerylates PB Polybutene PBT Polybutylene terephthalate PC Polycarbonate PCLD PolycaprolactDne PCTFE Polychlorotrlfluoroethylene PE Polyethylene PEEK Polyetheretherfcetone PEES Polyetherethersulphone PEI Polyetherimide PEK Polyetherketone PEN Polyethylenenaphthenate PES Polyethersulfone PEth Polyether PET Polyethylene terephthalate PF Phenol-formaldehyde PIB Palyisobutylene PUMA Polymethyl methacrylate PO Polyolefins PCM PolyoKymethylene= polyformaldehyde= polyacetal PP Polypropylene PPE Polyphenylene ether PPO Polyphenylene oxide PS Polystyrene PT Polyterpenes PTFE Polytetrafluoroethylene PUR Polyurethanes PVAC Polyvinyl acetate PVB Polyvinyl butyral PVC Polyvinyl chloride PVCC Polyvinyl chloride chlorinated PVDC Polyvinylidene chloride PVDF Polyvinylidene fluoride PVE Polyvinylether RF Resorcinol-formaldehyde SAN Styrene-acrylonitrile SB Styrenerbutadiene UF Urea-formaldehyde UP Unsaturated polyesters TZ0SX9TZ JUN 8 '92 10=29 BFG15759 908 730 1546 PAGE.020 JUN-08-1992 11:30 P*0* N*. M-OR-Rl t FROM LONZA, INC. R 8, D TO LIST Of ADDITIVES UPOATED TO 2 AUGUST ttft 92164476459 P.21 0 PM/RCF H. CAS N. 1I 4 NAME B SCF EEC SCF AGE CS/PM L L. M/ft NPA ADl Mf*9 RESTRIC TIOHS 4 7 t t 16 11 12 REMARKS DEADLINE t MAT MAI PL C 11 14 IS IS *0110 - ACETVLACETie ACID, SALTS 0 A* Rx AOADD * ACCTVUTEO BIYCERIDES 1 Ax Hi NS AOMD OOJ40-0A-J ACrmJlICINOLCIC ACID, RUTVL 7 ESTER lx A* AOSSO - "ACIP*. ALIPH. HOMOCAM. (CC-CZ4) R In Rx 1B1 20(40 - *ACIDS, ALIPH., HOHOCAM. {CS-C22), c-RUTTl AND OLCVL ESTERS lx Rx J07RD - SOIOO 10*10 *ACIDS, ALTON., HONOCRAM. (CR-Ctt), COMPOUNDS WITH DIETHANOLAMINE R lx *x SSI *ACIDS, ALIPH., MONOCARB. (MORE THAN ), ESTERS WITH MANNITOL ACIDS, ALIPH., MONOCARI. (MORE THAN Cl>, ESTERS WITH RENTAERYTHHXTOL Rxl Rx SSI,14?, ( MS ACIDS, ALIPH,, MOMOCARB. fCB-Ctt) ESTERS WITH POtTGLYCMOL , Clft-i***- 7W/7`fl 11040 IJ170 "ACIDS, ALIPH. HONOCARfe., HTDRORTUTED (C12-C20) AND THEIR SULPHONATED AND ACCTYLATED DERIVATIVES 9 lx Rx "ACIDS, ALIPH., MONOCARR, (CR-CE4), L1,Hn AND $ SALTS Rx Rx SSI SHOO - *ACIDS, ALIPH., MONOCARI., SAT.(MORE THAN C7), ESTERS WITH ALCOHOLS, ALIPH. HONOH. R lx Rx Hi 11260 "ACIDS, ALIPH., MOMOCARB. (CB-CRt), COMPOUNDS WITH trjcthandlahinc R Rx Rx 1E1T ACIDS, PATTY, 01HCAIZC0, SALTS RI.1Z.SI/) 31.12.P1/) * PA,PAM,PS, J1.12.R1/) * pve 13.)!.]/) R1.11.R1/) 11.31,*1/1 Pil 31.12.91/1 Jl.12.tl/) * 11.12.01/1 PA,PS,PVC J1.1Z.R1/1 * PS * 21615022 JUN 8 '92 10:29 BFG15760 908 730 1546 TOTFIL P.21 PAGE.021