LegalizeCommission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances (Text with EEA relevance)
Article 1
Amendments to Annex I to Regulation (EU) No 10/2011
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation.
Article 2
Transitional measures
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, which were first placed on the market before 1 February 2025 may remain on the market until the exhaustion of stocks.
In case a product from an intermediate stage of the manufacturing of plastic materials and articles or a substance intended for the manufacturing of such a product, material or article, which complies with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation and which is first placed on the market after 1 May 2024 does not comply with this Regulation, the declaration of compliance available for that substance or product shall indicate that it does not comply with the present rules, and that it can only be used in the manufacture of plastic materials and articles to be placed on the market before 1 February 2025.
Plastic materials and articles manufactured with the substance salicylic acid or untreated wood flour or fibres from a specific wood species may continue to be first placed on the market between 1 February 2025 and 31 January 2026 provided that the following conditions are fulfilled:
- (a) an application for the authorisation of the substance has been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004 before 1 August 2024;
- (b) the use of the substance to manufacture the plastic material and article, and the use of thereof, is limited to the intended conditions of use described in the application;
- (c) the information provided to the Authority in accordance with Article 9(1), point (b), of Regulation (EC) No 1935/2004 includes a statement that the application is an application in accordance with this paragraph.
Plastic materials and articles, which meet the conditions of the first subparagraph, may continue to be first placed on the market also after 31 January 2026 provided that the Authority has considered the application referred to in point (a) of the first subparagraph valid by that date.
Plastic materials and articles may be first placed on the market in accordance with paragraph 3 and remain on the market until the applicant withdraws its application or until the Commission adopts a decision granting or refusing the authorisation for the use of salicylic acid or the untreated wood flour or fibres from a specific wood species pursuant to Article 11(1) of Regulation (EC) No 1935/2004.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Annex I to Regulation (EU) No 10/2011 is amended as follows:
- (1) point 1, Table 1 is amended as follows:
- (a) entry 96 on wood flour and fibers, untreated, and entry 121 on salicylic acid are deleted;
- (b) entry 157 on phthalic acid, dibutyl ester is replaced by the following: ‘157 74880 0000084-74-2 phthalic acid, dibutyl ester (‘DBP’) yes no no 0,12 (32) (36) Only to be used as: (a) plasticiser in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in polyolefins in concentrations up to 0,05 % (w/w) in the final product. (7)’
- (c) entry 159 on phthalic acid, benzyl butyl ester is replaced by the following: ‘159 74560 0000085-68-7 phthalic acid, benzyl butyl ester (‘BBP’) yes no no 6 (32) (36) Only to be used as: (a) plasticiser in repeated use materials and articles; (b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formula and follow-on formula (*); (c) technical support agent in concentrations up to 0,1 % (w/w) in the final product. (7)’
- (d) entry 283 on phthalic acid, bis(2-ethylhexyl) ester is replaced by the following: ‘283 74640 0000117-81-7 phthalic acid, bis(2-ethylhexyl) ester (‘DEHP’) yes no no 0,6 (32) (36) Only to be used as: (a) plasticiser in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in concentrations up to 0,1 % (w/w) in the final product. (7)’
- (e) entry 728 on phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 is replaced by the following: ‘728 75100 0068515-48-0 0028553-12-0 phthalic acid, diesters with primary, saturated C 8-C 10 branched alcohols, more than 60 % C 9 (‘DINP’) yes no no
(26) (32) Only to be used as: (a) plasticiser in repeated use materials and articles; (b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formula and follow-on formula (*) (c) technical support agent in concentrations up to 0,1 % (w/w) in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. (7)’ - (f) entry 793 on triethanolamine is replaced by the following: ‘793 94000 0000102-71-6 triethanolamine yes no no
(37)’ - (g) entry 822 on perchloric acid, salts (perchlorate) is replaced by the following: ‘822 71983 14797-73-0 Perchloric acid, salts (perchlorate) yes no no
(38)’ - (h) entry 1007 on diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate is replaced by the following: ‘1007
976-56-7 diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate no yes no
Only to be used up to 0,2 % (w/w) based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)’ - (i) entry 1059 on poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is replaced by the following: ‘1059
147398-31-0 Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (‘PHBH’) no yes no
(35) The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food. (23)’ - (j) entry 1076 on Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester is replaced by the following: ‘1076
1227937-46-3 Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters yes no no 0,05
To be used only:
as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.
as an additive at up to 0,025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below’
- (k) the following entries are inserted at the end of Table 1 in numerical order: ‘1078
3319-31-1 tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate yes no no 1 (32) Only to be used as plasticiser to manufacture soft poly(vinyl chloride) Not to be used in contact with foods intended for infants (*) 1080 156157-97-0 (triethanolamine-perchlorate, sodium salt) dimer yes no no
(37) (38) Only to be used in rigid poly(vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III 1081 - N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids yes no no
(7) Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III. (30) 1082 52628-03-2 Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate no yes no 0,05
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate. SML expressed as the sum of the mono-, di- and triesters of phosphoric acid and the mono-, di-, tri- and tetraesters of diphosphoric acid 1083 2421-28-5 Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (‘BTDA’) no yes no 0,05
Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.’
‘(*) Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).’
- (2) in point 2, Table 2 is amended as follows:
- (a) entry 7 is replaced by the following: ‘7 19 20 1081 1,2 expressed as tertiary amine’
- (b) entry 26 is replaced by the following: ‘26 728 729 1,8 expressed as the sum of the substances’
- (c) entry 32 is replaced by the following: ‘32 8 72 73 138 140 157 159 207 242 283 532 670 728 729 775 783 797 798 810 815 1078 1085* 60 expressed as the sum of the substances (plasticisers) * Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085.’
- (d) the following entries are added: ‘36 157 159 283 1085 0,6 sum of phthalic acid, dibutyl ester (DBP), diisobutyl phthalate (DIBP), phthalic acid, benzyl butyl ester (BBP) and phthalic acid, bis(2-ethylhexyl) ester (DEHP) expressed as DEHP equivalents using the following equation: DBP5 + DIBP4 + BBP0,1 + DEHP*1. * See remark on FCM No 1085 in row 32 37 793 1080 0,05 expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine 38 822 1080 0,002 expressed as perchlorate – note 4 of table 3 applies’
- (3) in point 3, Table 3, the following entry is added: ‘(30) There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself’
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