Commission 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)

• CELEX: Regulation (EU) 2023/1442
• Articles: 4

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

1.   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.

2.   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.

3.   Plastic materials and articles manufactured with salicylic acid (FCM No 121) or manufactured with untreated wood flour or fibres from a specific wood species may continue to be first placed on the market after 1 February 2025 provided that the following conditions are fulfilled:

(a)

an application for the authorisation of that substance or of that untreated wood flour or fibre from a specific wood species 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 that substance or of that untreated flour or fibre from a specific wood species to manufacture a plastic material and article, and the use 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)(b) of Regulation (EC) No 1935/2004 includes a statement that the application is an application in accordance with this paragraph; and

(d)

the Authority has considered the application valid.

4.   Plastic materials and articles manufactured with the substance or the untreated wood flour or fibre subject to an application may then continue to be used until the applicant withdraws its application or until the Commission adopts a decision granting or refusing the authorisation for the use of that substance or wood flour or fibre 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 .

Schedules & Appendices

ANNEX

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 C 8 -C 10 branched alcohols, more than 60 % C 9 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:

a)

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.

b)

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: DBP*5 + DIBP*4 + BBP*0,1 + 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’