2002 No. 2834 (W.272)
The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002
Made
Coming into force
In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a), 31 and 48(1) of the Food Safety Act 1990F1, which are now exercisable in relation to Wales by the National Assembly for WalesF2 having regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyF3, and after consultation in accordance with section 48(4) and 4(B) of that Act, makes the following Regulations:
Functions of “the Secretary of State” so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by S.I. 1999/672, as amended by s.40(3) of the Food Standards Act 1999 (1999 c.28).
OJ No. L31, 1.2.2002, p1.
Title, commencement and application1
1
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 and shall come into force on 30th November 2002.
2
These Regulations apply to Wales only.
Amendments to the Plastic Materials and Articles in Contact with Food Regulations 19982
The Plastic Materials and Articles in Contact with Food Regulations 1998 F4 (“the principal Regulations”) shall be amended, in so far as they apply to Wales, in accordance with regulations 3 to 18.
3
Immediately after regulation 1 there shall be added the following regulation—
Scope of these Regulations1A
Notwithstanding the title to these Regulations—
a
regulations 3 and 9 to 12 apply also in relation to adhesives and to materials or articles covered by surface coatings; and
b
regulation 8A and regulation 8B apply only in relation to adhesives and to materials or articles covered by surface coatings.
4
In regulation 2 (interpretation)—
a
in paragraph (1)—
i
immediately after the definitions of “additive” there shall be inserted the following definitions—
“adhesive” means anything which, for the purposes of Commission Directive 2002/16, is included among the adhesives to which that Directive applies;
“BADGE” means 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether;
“BFDGE” means bis(hydroxyphenyl) methane bis(2,3-epoxypropyl) ethers;
ii
for the definition of “capable” there shall be substituted the following definition—
“capable” means capable as established—
a
in relation to any plastic material or article, under regulation 6; and
b
in relation to any adhesive or material or article covered by a surface coating, under regulation 8B;
iii
immediately after the definition of “capable” there shall be inserted the following definitions—
“Commission Directive 2001/62” means Commission Directive 2001/62/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs F5;
“Commission Directive 2002/16” means Commission Directive 2002/16/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs F6;
iv
For the definition of “the Directive” there shall be substituted the following definition - “
“the Directive” means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs F7;
”
,
v
immediately after the definition of “import” there shall be inserted the following definition—
“material or article covered by a surface coating” means anything which, for the purposes of Commission Directive 2002/16, is included among the materials and articles covered by surface coatings to which that Directive applies;
vi
immediately after the definition of “monomer” there shall be inserted the following definition—
“NOGE” means novolac glycidyl ethers not covered by Article 1(a) or (b) of Commission Directive 2002/16;
vii
at the end of the definition of “plastic material or article” there shall be added the following words “
, except that, where it is used in any provisions referred to in paragraph (5) below, to the extent that they implement or
relate to the enforcement of Commission Directive 2002/16, it means any material or article made of any type of plastic
”
; and
viii
after the definition of “sell” there shall be added the following definition—
“QMA” has the same meaning as it bears in the first sentence of the sub-paragraph relating to that term in paragraph 8 of Annex II to the Directive;
b
for paragraph (2) there shall be substituted the following provision—
2
For the purposes of these Regulations, the supply in the course of a business, otherwise than on sale, of any plastic material or article, adhesive or material or article covered by a surface coating, shall be deemed to be a sale of the plastic material or article, adhesive or material or article covered by a surface coating concerned.
and
c
immediately after paragraph (4) there shall be inserted the following paragraph—
5
The provisions referred to in the definition of “plastic material or article” in paragraph (1) of this regulation are regulations 3, 4, 4A, 5, 6, 10, 11 and 12 and Schedules 3 and 4.
5
In regulation 3 (restriction on the use, sale or importation of plastic materials and articles)—
a
for the heading there shall be substituted the following heading—
Restriction on the use, sale or importation of plastic materials and articles, adhesives and materials and articles covered by surface coatings
b
in paragraphs (1) and (2), immediately after the references to “plastic material or article”, wherever they appear, there
shall be inserted references to “
, adhesive or material or article covered by a surface coating
”
;
c
in sub-paragraph (4)(a)(iii) the word “or” shall be deleted;
d
for sub-paragraph (4)(a)(iv) there shall be substituted the following sub-paragraph—
iv
it does not comply with regulation 4(5), (5A) or (5B), 4A(4), (5) or (6), 5(4), (4A), (4B) or (4C), 7 or 7A(1) or 8A(4), (5) or (6); or
and
e
immediately after sub-paragraph (4)(a)(iv) there shall be added the following sub-paragraph—
v
it has been manufactured in contravention of a prohibition contained in regulation 4A(1), (2) or (3),
f
there shall be added at the end the following paragraph—
5
For the purposes of this regulation, an adhesive or a material or article covered by a surface coating fails to meet the requisite standards if—
i
it has been manufactured in contravention of a prohibition contained in regulation 8A(1), (2) or (3), or
ii
it does not comply with regulation 8A(4), (5) or (6).
6
In regulation 4 (restriction on manufacture with monomers)—
a
for the heading and paragraph (1) there shall be substituted the following provisions—
Restriction on manufacture with monomers of plastic materials and articles
1
Subject to the following paragraphs of this regulation, no person shall use in the manufacture of any plastic material or article any prohibited monomer, that is to say—
a
any monomer (not being one to which sub-paragraph (b) or (c) below relates) which is not—
i
of good technical quality;
ii
identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part I of Schedule 1, and
iii
used in accordance with the restrictions and specifications (if any) for that monomer set out or referred to in the corresponding entry in column 4 of that section;
b
BFDGE to the extent that they are used in such manufacture—
i
on or after 1st January 2005, or
ii
prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or
c
NOGE to the extent that it is used in such manufacture—
i
on or after 1st January 2005, or
ii
prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.
b
in paragraph (2)—
i
for sub-paragraph (b) there shall be substituted the following provisions - “
in the case of a plastic material or article manufactured on or after 30th November 2002 and before 1st January 2005, Section
A or B
”
, and
ii
for sub-paragraph (c), there shall be substituted the following provisions “
in the case of a plastic material or article manufactured on or after 1st January 2005, Section A.
”
;
c
for paragraph (3) there shall be substituted the following paragraph—
3
Paragraph (1)(a) of this regulation does not apply to the use of a monomer in the manufacture of any—
a
surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;
b
epoxy resins;
c
adhesives and adhesion promoters; or
d
printing inks.
d
in paragraph (4), for the expression “Paragraph (1)” there shall be substituted the expression “
Paragraph (1)(a)
”
;
e
immediately after paragraph (5) there shall be inserted the following paragraphs—
5A
No plastic material or article manufactured using BFDGE as a monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
5B
On or after 1st March 2003, no plastic material or article manufactured using NOGE as a monomer shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.
and
f
in paragraph (7)—
i
for the expression “paragraph (1)” there shall be substituted the expression “
paragraph (1)(a)
”
, and
ii
after the words “Part I of Schedule 1” there shall be inserted the words “
or to which sub-paragraph (b) or (c) of that paragraph relates
”
.
7
Immediately after regulation 4 (restriction on manufacture with monomers) there shall be inserted the following regulation—
Restriction on manufacture of plastic materials and articles using certain substances other than as monomers or additives4A
1
No person shall use BADGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive—
a
on or after 1st January 2005; or
b
prior to that date in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
2
No person shall use BFDGE in the manufacture of any plastic material or article, where the use is not as a monomer or an additive—
a
on or after 1st January 2005; or
b
prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
3
No person shall use NOGE in the manufacture of any plastic material or article, where the use is not as a monomer or additive—
a
on or after 1st January 2005; or
b
prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.
4
No plastic material or article manufactured using BADGE other than as a monomer or an additive shall be capable of transferring constituents of BADGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
5
No plastic material or article manufactured using BFDGE other than as a monomer or an additive shall be capable of transferring constituents of BFDGE to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
6
On and after 1st March 2003, no plastic material or article manufactured using NOGE other than as a monomer or an additive shall fail to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.
8
In regulation 5 (restriction on manufacture with additives)—
a
for the heading and paragraph (1) there shall be substituted the following provisions—
Restriction on manufacture of plastic materials and articles with additives
1
Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic material or article any prohibited additive, that is to say—
a
any additive identified by PM/REF No. , CAS No. (if any) and name in columns 1, 2 and 3 respectively of Part I of Schedule 2 or columns 1, 2 and 3 respectively of Part II of that Schedule, which is not—
i
of good technical quality, and
ii
used in accordance with the restrictions and specifications (if any) for that additive set out in the corresponding entry in column 4 of Part I or Part II, as appropriate;
b
BADGE to the extent that it is used in such manufacture—
i
on or after 1st January 2005, or
ii
prior to that date in contravention of the restriction specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex;
c
BFDGE which is used in such manufacture—
i
on or after 1st January 2005, or
ii
prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex; or
d
NOGE not otherwise covered by this paragraph and which is used in such manufacture—
i
on or after 1st January 2005, or
ii
prior to that date but on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.
b
in paragraph (2), immediately after the expression “Part I” there shall be added the expression “
or Part II
”
;
c
for paragraph (3), there shall be substituted the following paragraph—
3
Part III of Schedule 2 shall have effect to supplement this regulation and Parts I and II of that Schedule.
d
in paragraph (4)—
i
for the expression “Part I of Schedule 2” there shall be substituted the expression “
Part I or Part II of Schedule 2,
”
, and
ii
in each of sub-paragraphs (a) and (b), for the word “therein” there shall be substituted the expression “
that column
”
.
e
between paragraphs 4 and 5 there shall be inserted the following paragraphs—
4A
No plastic material or article manufactured using BADGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex I to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
4B
No plastic material or article manufactured using BFDGE as an additive shall be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
4C
On and after 1st March 2003, no plastic material or article manufactured using NOGE as an additive shall fall to comply with the requirements of the first sentence of Article 4 of Commission Directive 2002/16.
and
f
in paragraph (5), for the expression “Part I of Schedule 2” there shall be substituted the expression “
Part I or Part II of Schedule 2,
”
.
9
n regulation 6 (method of testing capability of transferring constituents)—
a
for the heading, the introductory words and paragraph (1)(a) there shall be substituted the following heading—
Method of testing the capability of plastic materials or articles of transferring constituents and methods of analysis;
1
For the purposes of these Regulations, a plastic material or article shall be treated as being capable of transferring constituents other than NOGE to food with which it may come into contact to the extent that such capability is established—
a
in any case other than one to which sub-paragraph (b) below relates, and subject to Article 8.4 of Commission Directive 2001/62 (which may be applied on compliance with the conditions stated therein) by the verification methods specified in Schedules 3 and 4;
and
b
after paragraph (3) there shall be added the following provisions—
“
The specific migration from a plastic material or article shall, where applicable, be determined in the manner specified in the relevant sub-division of paragraph 8 of the Annex to the Directive.
5
The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.
6
The specific migration from a plastic material or article of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.
7
Whether or not the detection requirement specified in Article 4 of Commission Directive 2002/16 is complied with in relation to a plastic material or article shall be determined in the manner specified in the second sentence of that Article.
8
The quantity of a constituent in a plastic material or article shall, where applicable, be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term “QM(T)” or, as the case may be, the sub-paragraph of that paragraph relating to the term “QMA”.
10
For regulation 7A (specifications) there shall be substituted the following regulation—
Specifications7A
1
Subject to paragraph (3), no plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling shall be capable of transferring primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which that plastic material or article may come into contact.
2
Schedule 2B shall have effect for the purpose of prescribing, for certain items listed in Part I of Schedule 1, Part I or II of Schedule 2 or Schedule 2A, the specifications for those items which are referred to in column 4 of the Part or, as the case may be, Schedule concerned.
3
For the purposes of paragraph (1), “detectable quantity” means a quantity of at least DLO.02 milligrams per kilogram of food or food simulant (analytical tolerance included).
11
Immediately after regulation 8 (labelling) there shall be inserted the following regulations—
Restriction on manufacture with certain substances of adhesives materials and articles covered by surface coatings and adhesives8A
1
No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use BADGE in the manufacture of any—
a
adhesive; or
b
material or article covered by a surface coating.
on or after 1st January 2005, or prior to that date, in contravention of the restriction specified in paragraph 1 of Annex 1 to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
2
No person shall (in any case not covered by Article 1.2 of Commission Directive 2002/16) use BFDGE in the manufacture of any—
a
adhesive; or
b
material or article covered by a surface coating
on or after 1st January 2005, or prior to that date in contravention of the restriction specified in paragraph 1 of Annex II to Commission Directive 2002/16, as read with the second sentence of paragraph 2 of that Annex.
3
No person shall (in any case not covered by Article 1(2) of Commission Directive 2002/16) use NOGE in the manufacture of any—
a
adhesive; or
b
material or article covered by a surface coating
on or after 1st January 2005, or prior to that date but, on or after 1st March 2003, in contravention of the restriction specified in the first sentence of Article 4 of Commission Directive 2002/16.
4
No adhesive, or material or article covered by a surface coating, manufactured using BADGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BADGE to food with which the adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex 1 to that Directive, as read with the second sentence of paragraph 2 of that Annex.
5
No adhesive, or material or article covered by a surface coating, manufactured using BFDGE and not covered by Article 1(2) of Commission Directive 2002/16, shall be capable of transferring constituents of BFDGE to food with which that adhesive or, as the case may be, material or article, may come into contact, in quantities exceeding the appropriate limit specified in paragraph 1 of Annex II to that Directive, as read with the second sentence of paragraph 2 of that Annex.
6
On and after 1st March 2003, no adhesive, or material or article covered by a surface coating, manufactured using NOGE and not covered by Article 1(2) of Commission Directive 2002/16, shall fail to comply with the requirements of the first sentence of Article 4 of that Directive.
Method of testing the capability of materials or articles covered by surface coatings and adhesives of transferring constituents and methods of analysis8B
1
Subject to paragraphs (2) and (3) of this regulation, for the purposes of regulation 8A(1), (2), (4) and (5) an adhesive or a material or article covered by a surface coating shall be treated as being capable of transferring BADGE or, as the case may be, BFDGE to food with which it may come into contact to the extent that it is established for those purposes by the verification methods specified in Section A or Schedule 3 and in Schedule 4.
2
Subject to paragraph (3) of this regulation, in Section A of Schedule 3 and in Schedule 4, references to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, the food with which the substance may come into contact.
3
For the purposes of paragraphs (1) and (2) of this regulation, Schedules 3 and 4 shall have effect as if—
a
the references in Section A of Schedule 3 and in Schedule 4 to “a plastic material or article” were references to “an adhesive or a material or article covered by a surface coating”; and
b
the references in paragraph 4(3) and (4) of Section A of Schedule 3 to “regulation 7, Schedule 1 or Schedule 2” were references to “a migration limited referred to in regulation 8A(4) or (5)”; and
c
the reference in paragraph 5 of Part II of Schedule 4 and paragraph 2(1)(b) of Part III of that Schedule to “regulation 7 or Schedule 1” were a reference to “regulation 8A(4) or (5)”.
4
The specific migration from an additive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex I to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.
5
The specific migration from an adhesive or a material or article covered by a surface coating of the substances listed in paragraph 1 of Annex II to Commission Directive 2002/16 shall be determined in the manner specified in paragraph 3 of that Annex.
6
Whether or not the detection limit specified in Article 4 of Commission Directive 2002/16 is complied with in relation to an adhesive or a material or article covered by a surface coating shall be determined in the manner specified in the second and third sentences of that Article.
12
In regulation 10 (offences)—
a
in paragraph (1), for the expression “regulation 3, 4(1), 5(1) or 8” there shall be substituted the expression “
3, 4(1), 4A(1), (2) or (3), 5(1), 8 or 8A(1), (2) or (3)
”
;
b
in each of paragraphs (9) and (10), immediately after the words “plastic material or article” there shall be inserted the
words “
or, as the case may be, adhesive or material or article covered by a surface coating,
”
; and
c
immediately after paragraph (15) there shall be added the following paragraphs—
16
Subject to paragraph (18) of this regulation, in any proceedings for an offence under these Regulations, it shall be a defence to prove that—
a
the act constituting the offence was committed in relation to a plastic material or article which was put into circulation in the European Community before 30th November 2002; and
b
the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (17) below had not been in force at the time that matter occurred.
17
The provisions referred to in paragraph (16) of this regulation are regulations 5(d), 6(b), 8(a), (b) and (d), 10, 12(a) and 15 to 17 of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002 which implement or provide for the enforcement of the requirements of Commission Directive 2001/62 to which Article 2 of that Directive applies.
18
For the purposes of paragraph (16) of this regulation, “free circulation” shall have the same meaning as in Article 2 of Commission Directive 2001/62.
19
In any proceedings for an offence under these Regulations, it shall be a defence to prove that—
a
the act constituting the offence consisted was the sale of an adhesive or a material or article covered by a surface coating—
i
which was brought into contact with food before 28th February 2003,
ii
on which (in the case of a material or article covered by a surface coating) the date of filling appeared at the time of sale; and
iii
the labelling or marking of which at the time of sale (in the case of a material or article covered by a surface coating) complied with the requirement as regards labelling relating to durability contained in Article 2.1(a) of Directive 2000/13/EC of the European Parliament and the Council on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs F8;
b
the sale would not have constituted an offence under these Regulations if the amendments made to them by the provisions referred to in paragraph (20) below had not been in force at the time of sale.
20
The provisions referred to in paragraph (18) above are regulations 5(b) and (f), 8A and 12(a) of those provisions of the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002
13
In regulation 11 (presumption as to food with which a plastic material or article is to come into contact) and the heading
thereto, immediately after the words “plastic material or article”, wherever they appear, there shall be inserted the words
“
, adhesive or material or article covered by a surface coating,
”
.
14
In regulation 12 (application of other provisions)—
a
in paragraph (1), after the words “plastic materials or articles” there shall be added the words “
, adhesives and materials or articles covered by a surface coating
”
; and
b
in paragraph (3), for the words “relate to plastic materials or articles” there shall be substituted the words “
apply to plastic materials or articles, adhesives or materials or articles covered by a surface coating
”
.
15
In Schedule 1 (monomers authorised without time limit, monomers authorised up to the end of 2001, monomers authorised up to the end of 1998 and supplementary)—
a
in Section A of Part I—
i
in the case of each monomer listed in Part I of Schedule 1 to these Regulations, the item number and letter, PM/REF No. CAS No. (if any), name and restriction or specification specified for that monomer in that Part shall be inserted in the appropriate numerical position for that item number and letter,
ii
in the case of each monomer named in the second column of Part II of Schedule 1 to these Regulations, for the item number and letter for that monomer specified opposite to it in the first column (item) there shall be substituted the item number and letter for it specified in the first column (item) of that Part, and
iii
in the case of each monomer named in the first column of Part III of Schedule 1 to these Regulations, for the entry for that monomer specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part;
b
for Section B of Part I there shall be substituted the contents of Part IV of Schedule 1 to these Regulations; and
c
in Part II, for paragraph 4 there shall be substituted the following paragraph—
4
Where an entry in column 4 of Part I of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part:
1
Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.
2
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.
3
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.
4
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.
5
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.
14
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.
21
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.
16
In Schedule 2 (additives and supplementary)—
a
In Part I—
i
for the heading “Part I Additives” there shall be substituted the heading “
Part I: Incomplete list of additives used in the manufacture of plastic materials and articles (not being additives to which
paragraph 5 of Part III of this Schedule applies)
”
,
ii
in the case of each additive listed in Part I of Schedule 2 to these Regulations, the item number and letter, PM/REF No. , CAS No. (if any), name and restriction or specification (if any) specified for that additive in that Part shall be inserted in the appropriate numerical position for that item number and letter,
iii
in the case of each additive named in the second column of Part II of Schedule 2 to these Regulations, for the item number for that additive specified opposite to it in the column headed “Item” there shall be substituted the item number for it specified in the first column (item) of that Part,
iv
in the case of each additive named in the first column of Part III of Schedule 2 to these Regulations, for the entry for that additive specified opposite to it in column 4 (restrictions and specifications) there shall be substituted the entry for it specified in the second column (restrictions and specifications) of that Part, and
v
all the entries for the additive Silicic acid, salts, (item 241) shall be deleted;
b
immediately after Part I there shall be inserted the contents of Part IV of Schedule 2 to these Regulations (which shall become Part II of Schedule 2 to the principal Regulations on the coming into force of these Regulations);
c
in Part II—
i
in the heading, for the expression “Part II” there shall be substituted the expression “
Part III
”
;
ii
in paragraph 1, for the expression “Part I” there shall be substituted the expression “
Parts I and II
”
;
iii
in each of paragraphs 2, 3 and 4, immediately after the expression “Part I” there shall be added the expression “
or Part II
”
; and
iv
for paragraph 4 there shall be substituted the following paragraph—
4
Where an entry in column 4 of Part I or in column 4 of Part II of this Schedule (in each case restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts:
1
Warning: there is a risk that the SML could be exceeded in fatty food simulants.
2
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.
3
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.
4
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.
5
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.
6
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.
7
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.
8
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 42400, 64320, 73040, 85760, 85840, 85920 and 95725.
9
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.
10
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.
11
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800 and 92000.
12
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.
13
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.
14
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.
15
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.
16
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.
17
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 67600, 67680 and 67760.
18
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.
19
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.
20
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.
21
SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260 and 18670.
and
d
immediately after paragraph 4 there shall be added the following paragraph—
5
In the case of the substances listed in Part II of this Schedule, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect from 1st January 2004 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EECF9 and Council Directive 85/572/EECF10.
17
In Schedule 2B (specifications) in the case of each substance listed in Schedule 3 to these Regulations, the item number and letter, PM/REF No. and specification set out for that substance in that Schedule shall be inserted in the appropriate numerical position for that item number and letter.
18
In Schedule 3 (provisions applicable when testing compliance with the migration limits)—
a
in each of sub-paragraphs (3) and (4) of paragraph 4, after the words “specified in regulation” there shall be inserted the
expression “
4(5A), 4A(4) or (5), 5(4A) or (4B), or
”
; and
b
for sub-paragraph (2)(b) of paragraph 8 there shall be substituted the following sub-paragraph—
b
12 mg/kg or, as the case may be, 2 milligrams per square decimeter in migration tests using other simulants referred to in Schedule 4.
Amendment of the Food Safety (Sampling and Qualifications) Regulations 199019
In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990 F11 (provisions to which those Regulations do not apply) the reference in the second column, opposite the reference in the first column to the Plastic Materials and Articles in Contact with Food Regulations 1998, shall be amended in relation to Wales so as to read “S.I. 1998/1376 as amended by S.I. 2000/3162 and S.I. 2002/2834.
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 F12
SCHEDULE 1
PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
---|---|---|---|---|
15A |
11530 |
00999-61-1 |
Acrylic acid, 2-hydroxypropyl ester |
QMA = 0.05 mg/6 dm2 |
28B |
12763 |
00141-43-5 |
2-Aminoethanol |
SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer |
28C |
12765 |
84434-12-8 |
N-(2-aminoethyl)-beta-alanine, sodium salt |
SML = 0.05 mg/kg |
38A |
13395 |
04767-03-7 |
2,2-Bis(hydroxymethyl) propionic acid |
QMA = 0.05 mg/6 dm2 |
47A |
13617 |
00080-09-1 |
Bisphenol S |
As item 86A |
49B |
13810 |
00505-65-7 |
1,4-Butanediol formal |
QMA = 0.05 mg/6 dm2 |
52A |
13932 |
00598-32-3 |
3-Buten-2-ol |
QMA = ND (DL = 0.02 mg/6 dm2). To be used only as a co-monomer for the preparation of polmeric additive |
70A |
15030 |
00931-88-4 |
Cyclooctene |
SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC |
76A |
15370 |
03236-53-1 |
1,6-Diamino-2,2, 4-trimethylhexane |
QMA = 5 mg/6 dm2 |
76B |
15400 |
03236-54-2 |
1,6-Diamino-2,4, 4-trimethylhexane |
QMA = 5 mg/6 dm2 |
77A |
15610 |
00080-07-9 |
4,4’-Dichlorodiphenyl sulphone |
SML = 0.05 mg/kg |
86A |
16090 |
00080-09-01 |
4,4’-Dihydroxydiphenyl sulphone |
SML = 0.05 mg/kg |
88B |
16390 |
00126-30-7 |
2,2-Dimethyl-1, 3-propanediol |
SML = 0.05 mg/kg |
121B |
19110 |
04098-71-9 |
1-Isocyanato-3-isocyanatomethyl-3,5, 5-trimethylcyclohexane |
QM(T) = 1 mg/kg in FP (as NCO) |
122A |
19243 |
00078-79-5 |
Isoprene |
As item 145A |
126A |
19490 |
00947-04-6 |
Laurolactam |
SML = 5 mg/kg |
135A |
20260 |
00101-43-9 |
Methacrylic acid, cyclohexyl ester |
SML = 0.05 mg/kg |
135B |
20410 |
02082-81-7 |
Methacrylic acid, diester with 1, 4-butanediol |
SML = 0.05 mg/kg |
135D |
20590 |
00106-91-2 |
Methacrylic acid, 2,3-epoxypropyl ester |
QMA=0.02mg/6dm2 |
144A |
21520 |
01561-92-8 |
Methallylsulphonic acid, sodium salt |
SML = 5 mg/kg |
145A |
21640 |
00078-79-5 |
2-Methyl-1,3-butadiene |
QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included) |
145C |
21765 |
106246-33-7 |
4,4’-Methylenebis (3-chloro-2, 6-diethylaniline) |
QMA = 0.05 mg/6 dm2 |
145D |
21821 |
00505-65-7 |
1,4-(Methylenedioxy) butane |
As item 49B |
148A |
22360 |
01141-38-4 |
2,6-Naphthalenedi carboxylic acid |
SML = 5 mg/kg |
150A |
22437 |
00126-30-7 |
Neopentylglycol |
As item 88B |
156A |
22778 |
07456-68-0 |
4,4’-Oxybis (benzenesulphonyl azide) |
QMA = 0.05 mg/6 dm2 |
159A |
22900 |
00109-67-1 |
1-Pentene |
SML = 5 mg/kg |
184A |
24073 |
000101-90-6 |
Resorcinol diglycidyl |
QMA = 0.005 mg/g dm2. Not for ether use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer |
214A |
25380 |
Trialkyl acetic acid (C7-C17), vinyl esters (= vinyl versatate) |
QMA = 0.05 mg/g dm2 |
|
215A |
25450 |
26896-48-0 |
Tricyclodecanedimethanol |
SML = 0.05 mg/kg |
217A |
25900 |
00110-88-3 |
Trioxane |
SML = 0.05 mg/kg |
PART IILIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Item |
Name |
---|---|
52B |
4-tert-Butylphenol |
88C |
1.3 Dioxolane |
121C |
Isophthalic acid |
135C |
Methacrylic acid, 2-(dimethylamino) ethyl ester |
145B |
3-Methyl-1-butene |
159B |
Perfluoropropyl perfluorovinyl ether |
214B |
Triallylamine |
PART III LIST OF MONOMERS FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Name |
Restrictions and specifications |
---|---|
2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether (= BADGE) |
In any case not covered by article 1.2 of Commission Directive [ 2002/16], use must be before 1st January 2005 and be as specified in paragraph 1 of Annex I to that Directive |
4,4’-Dihydroxybenzophenone |
SML(T) = 6 mg/kg (14) |
Formaldehyde |
SML(T) = 15 mg/kg (21) |
Hexamethylenetetramine |
SML(T) = 15 mg/kg (expressed as formaldehyde) (21) |
1,3-Phenylenediamine |
SML = ND (DL = 0.02 mg/kg, analytical tolerance included) |
PART IV PROVISIONS SUBSTITUTED FOR SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
SECTION B:MONOMERS AUTHORISED UP TO THE END OF 2004
Item
PM/REF No.
CAS No.
Name
Restrictions and specifications
1
10599/90A
61788-89-4
Acids, fatty, unsaturated (C18), dimers, distilled
2
10599/91
61788-89-4
Acids, fatty, unsaturated (C18), dimers, non-distilled
3
10599/92A
68783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
4
10599/93
68783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
5
11500
00103-11-7
Acrylic acid, 2-ethylhexyl ester
6
13050
00528-44-9
1,2, 4-Benzenetricarboxylic acid
As item 23
7
13075
00091-76-9
Benzoguanamine
8
13720
00110-63-4
1,4-Butanediol
9
14260
00502-44-3
Caprolactone
10
14800
03724-65-0
Crotonic acid
11
15310
00091-76-9
2,4-Diamino-6-phenyl-1,3,5-triazine
12
15730
00077-73-6
Dicyclopentadiene
13
16210
06864-37-5
3,3’-Dimethyl-4-4’-diaminodicyclo-hexylmethane
14
16690
01321-74-0
Divinylbenzene
15
16697
00693-23-2
Dodecanedioic acid
16
17110
16219-75-3
5-Ethylidenebicyclo [2.2.1]hept-2-ene
17
18370
00592-45-0
1,4-Hexadiene
18
18700
00629-11-8
1,6-Hexanediol
19
21370
10595-80-9
Methacrylic acid, 2-sulphoethyl ester
20
21400
54276-35-6
Methacrylic acid, sulphopropyl ester
21
21970
00923-02-4
N-methylolmetha- crylamide
22
22210
00098-83-9
Alpha-methylstyrene
23
25540
00528-44-9
Trimellitic acid
QM(T) = 5 mg/kg in FP
24
25550
00552-30-7
Trimellitic anhydride
QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)
25
25840
03290-92-4
1,1,1-Trimethylopropane trimethacrylate
26
26230
00088-12-0
Vinylpyrrolidone
SCHEDULE 2
PART ILIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
---|---|---|---|---|
19A |
35160 |
06642-31-5 |
6-Amino-1, 3-dimethyluracil |
SML = 5 mg/kg |
19B |
35170 |
00141-43-5 |
2-Aminoethanol |
SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer |
19C |
35284 |
00111-41-1 |
N-(2-aminoethyl) ethanolamine |
SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer |
36E |
38840 |
154862-43-8 |
Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphite |
SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl) pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol) |
38A |
39925 |
129228-21-3 |
3,3-Bis(methoxymethyl)-2,5-dimethyl hexane |
SML = 0.05 mg/kg |
41A |
41120 |
10043-52-4 |
Calcium chloride |
|
45A |
41840 |
00105-60-2 |
Caprolactam |
SML(T) = 15 mg/kg (5) |
72B |
47210 |
26427-07-6 |
Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer] |
In compliance with the specifications laid down in Schedule 2B |
73A |
47540 |
27458-90-8 |
Di-tert-dodecyl disulfide |
SML = 0.05 mg/kg |
73D |
48620 |
00123-31-9 |
1,4-Dihydroxybenzene |
SML = 0.6 mg/kg |
73E |
48720 |
00611-99-4 |
4,4’-Dihydroxybenzophenone |
SML(T) = 6 mg/kg (14) |
77A |
52645 |
10436-08-5 |
Cis-11-eicosenamide |
|
164A |
64800 |
00110-16-7 |
Maleic acid |
SML(T) = 30 mg/kg (4) |
167A |
65920 |
66822-60-4 |
[N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers |
|
191A |
73160 |
Phosphoric acid, mono-and di-n-alkyl (C16 and C18) esters |
SML = 0.05 mg/kg |
|
195B |
76730 |
Polydimethylsiloxane, gamma-hydroxypropylated |
SML = 6 mg/kg |
|
240B |
85680 |
01343-98-2 |
Silicic acid |
|
271A |
92150 |
01401-55-4 |
Tannic acids |
According to the JECFA specifications |
279A |
93270 |
00108-78-1 |
2,4,6-Triamino-1,3, 5-triazine |
SML = 30 mg/kg |
281A |
95270 |
161717-32-4 |
2,4,6-Tris(tert-butyl) phenyl 2-butyl-2-ethyl-1, 3-propanediol phosphite |
SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP) |
PART IILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Item |
Name |
---|---|
36F |
Bis(3-4-dimethylbenzylidene)sorbitol |
38B |
Bis(polyethyleneglycol)hydroxymethyl-phosphonate |
73B |
Diethyleneglycol |
73C |
1,1-Difluoroethane |
73F |
2,4-Dimethyl-6-(1-methylpentadecyl)phenol |
191B |
Phosphoric acid, trichloroethyl ester |
195C |
Polyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol |
208B |
Poly (zinc glycerolate) |
240C |
Silicic acid, lithium, magnesium, sodium salt |
281B |
Vermiculite, reaction product with citric acid, lithium salt |
281C |
Water |
281D |
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks |
281E |
White mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks |
PART IIILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED
Name |
Restrictions and specifications |
---|---|
Bis(polyethylenelycol)hydroxymethyl-phosphonate |
SML = 0.6 mg/kg. Authorised until 1st January 2004 |
Copper iodide |
SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine) |
2’-(2-Hydroxy-3,5’-di-tert-butylphenyl)-5-chlorobenzotriazole |
SML(T) = 30 mg/kg (18) |
PART IVPROVISIONS INSERTED AFTER PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
PART II:INCOMPLETE LIST OF ADDITIVES USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES (BEING ADDITIVES TO WHICH PARAGRAPH 5 OF PART III OF THIS SCHEDULE APPLIES)
Item
PM/REF No.
CAS No.
Name
Restrictions and specifications
1
30180
02180-18-9
Acetic acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
2
31520
61167-58-6
Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5- methylbenzyl)-4-methylphenyl ester
SML = 6 mg/kg
3
31920
00103-23-1
Adipic acid, bis(2-ethyllhexyl) ester
SML = 18 mg/kg (1)
4
34230
Alkyl(C8-C22)sulphonic acids
SML = 6 mg/kg
5
35760
01309-64-4
Antimony trioxide
SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
6
36720
17194-00-2
Barium hydroxide
SML(T) = 1 mg/kg (11) (expressed as barium)
7
36800
10022-31-8
Barium nitrate
SML(T) = 1 mg/kg (11) (expressed as barium)
8
38240
00119-61-9
Benzophenone
SML = 0.6 mg/kg
9
38560
07128-64-5
2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene
SML = 0.6 mg/kg
10
38700
63397-60-4
Bis(2-carbobutoxyethyl)tin-bis(isooctylmercaptoacetate)
SML = 18 mg/kg
11
38800
32687-78-8
N,N’-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide
SML = 15 mg/kg
12
38820
26741-53-7
Bis(2,4-di-tert-butylphenyl) pentaery-thritol diphosphite
SML = 0.6 mg/kg
13
39060
35958-30-6
1,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane
SML = 5 mg/kg
14
39090
N,N-bis(2-hydroxyethyl)alkyl (C8-C18)amine
SML(T) = 1.2 mg/kg (12)
15
39120
N,N-bis(2-hydroxyethyl)alkyl (C8-C18)amine hydrochlorides
SML(T) = 1.2 mg/kg (12) (expressed as N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine)
16
40000
00991-84-4
2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine
SML = 30 mg/kg
17
40020
110553-27-0
2,4-Bis(octylthiomethyl)-6-methylphenol
SML = 6 mg/kg
18
40160
61269-61-2
N,N’-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer
SML = 2.4 mg/kg
19
40800
13003-12-8
4,4’-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)
SML = 6 mg/kg
20
40980
19664-95-0
Butyric acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
21
42000
63438-80-2
(2-Carbobutoxyethyl)tin-tris (isooctylmercaptoacetate)
SML = 30 mg/kg
22
42400
10377-37-4
Carbonic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)
23
42480
00584-09-8
Carbonic acid, rubidium salt
SML = 12 mg/kg
24
43600
04080-31-3
1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride
SML = 0.3 mg/kg
25
43680
00075-45-6
Chlorodifluoromethane
SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 2B
26
44960
11104-61-3
Cobalt oxide
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
27
45440
Cresols, butylated, styrenated
SML = 12 mg/kg
28
46720
04130-42-1
2,6-Di-tert-butyl-4-ethylphenol
QMA = 4.8 mg/6 dm2
29
47600
84030-61-5
Di-n-dodecyltin bis (isooctyl mercaptoacetate)
SML = 12 mg/kg
30
48640
00131-56-6
2,4-Dihydroxybenzophenone
SML(T) = 6 mg/kg (14)
31
48800
00097-23-4
2,2’-Dihydroxy-5,5’-dichlorodiphenylmethane
SML = 12 mg/kg
32
48880
00131-53-3
2,2’-Dihydroxy-4-methoxybenzophenone
SML(T) = 6 mg/kg (14)
33
49600
26636-01-1
Dimethyltin bis(isooctyl mercaptoacetate)
SML(T) 0.18 mg/kg (15) (expressed as tin)
34
49840
02500-88-1
Dioctadecyl disulphide
SML = 3 mg/kg
35
50160
Di-n-octylin bis(n-alkyl(C10-C16) mercapto acetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
36
50240
10039-33-5
Di-n-octyltin bis(2-ethyllhexyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
37
50320
15571-58-1
Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
38
50360
Di-n-octyltin bis(ethyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
39
50400
33568-99-9
Di-n-octyltin bis(isooctyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
40
50480
26401-97-8
Di-n-octyltin bis(isooctyl mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
41
50560
Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
42
50640
03648-18-8
Di-n-octyltin dilaurate
SML(T) = 0.04 mg/kg (16) (expressed as tin)
43
50720
15571-60-5
Di-n-octyltin dimaleate
SML(T) = 0.04 mg/kg (16) (expressed as tin)
46
50960
69226-44-4
Di-n-octyltin ethyleneglycol bis (mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
47
51040
15535-79-2
Di-n-octyltin mercaptoacetate
SML(T) = 0.04 mg/kg (16) (expressed as tin)
48
51120
Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate
SML(T) = 0.04 mg/kg (16) (expressed as tin)
49
51570
00127-63-9
Diphenyl sulphone
SML = 3 mg/kg
50
51680
00102-08-9
N,N’-diphenylthiourea
SML = 3 mg/kg
51
52000
27176-87-0
Dodecylbenzenesulphonic acid
SML = 30 mg/kg
52
52320
52047-59-3
2-(4-Dodecylphenyl)indole
SML = 0.06 mg/kg
53
52880
23676-09-7
4-Ethoxybenzoic acid, ethyl ester
SML = 3.6 mg/kg
54
53200
23949-66-8
2-Ethoxy-2’-ethyloxanilide
SML = 30 mg/kg
55
58960
00057-09-0
Hexadecyltrimethylammonium bromide
SML = 6 mg/kg
56
59120
23128-74-7
1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)
SML = 45 mg/kg
57
59200
35074-77-2
1,6-Hexamethylene-bis(3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionate)
SML = 6 mg/kg
58
60320
70321-86-7
2-(2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl) benzotriazole
SML = 1.5 mg/kg
59
60400
03896-11-5
2-(2’-Hydroxy-3’-tert-butyl-5’-methylphenyl)-5-chlorobenzotriazole
SML(T) = 30 mg/kg (18)
60
60800
65447-77-0
1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymer
SML = 30 mg/kg
61
61280
03293-97-8
2-Hydroxy-4-n-hexyloxybenzophenone
SML(T) = 6 mg/kg (14)
62
61360
00131-57-7
2-Hydroxy-4-methoxybenzophenone
SML(T) = 6 mg/kg (14)
63
61440
02440-22-4
2-(2-Hydroxy-5-methylphenyl) benzotriazole
SML(T) = 30 mg/kg (18)
64
61600
01843-05-6
2-Hydroxy-4-n-octyloxybenzophenone
SML(T) = 6 mg/kg (14)
65
63200
51877-53-3
Lactic acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
66
64320
10377-51-2
Lithium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium)
67
65120
07773-01-5
Manganese chloride
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
68
65200
12626-88-9
Manganese hydroxide
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
69
65280
10043-84-2
Manganese hypophosphite
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
70
65360
11129-60-5
Manganese oxide
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
71
65440
Manganese pyrophosphite
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
72
66360
85209-91-2
2-2’-Methylene bis(4,6-di-tert-butylphenyl)sodium phosphate
SML = 5 mg/kg
73
66400
00088-24-4
2-2’-Methylenebis(4-ethyl-6-tert-butylphenol)
SML(T) = 1.5 mg/kg (19)
74
66480
00119-47-1
2-2’-Methylenebis(4-methyl-6-tert -butylphenol)
SML(T) = 1.5 mg/kg (19)
75
67360
67649-65-4
Mono-n-dodecyltin tris(isooctyl mercaptoacetate)
SML = 24 mg/kg
76
67520
54849-38-6
Monomethyltin tris(isooctyl mercaptoacetate)
SML(T) = 0.18 mg/kg (15) (expressed as tin)
77
67600
Mono-n-octyltin tris(alkyl(C10-C16)-mercaptoacetate)
SML(T) = 1.2 mg/kg (17) (expressed as tin)
78
67680
27107-89-7
Mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)
SML(T) = 1.2 mg/kg (17) (expressed as tin)
79
67760
26401-86-5
Mono-n-octyltin tris(isooctyl mercaptoacetate)
SML(T) = 1.2 mg/kg (17) (expressed as tin)
80
68078
27253-31-2
Neodecanoic acid, cobalt salt
SML(T) = 0.05 mg/kg (expressed as neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC
81
68320
02082-79-3
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxylphenyl)propionate
SML = 6 mg/kg
82
68400
10094-45-8
Octadecylerucamide
SML = 5 mg/kg
83
69840
16260-09-6
Oleylpalmitamide
SML = 5 mg/kg
84
72160
00948-65-2
2-Phenylindole
SML = 15 mg/kg
85
72800
01241-94-7
Phosphoric acid, diphenyl 2-ethylhexyl ester
SML = 2.4 mg/kg
86
73040
13763-32-1
Phosphoric acid, lithium salts
SML(T) = 0.6 mg/kg (8) (expressed as lithium)
87
73120
10124-54-6
Phosphoric acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
88
74400
Phosphorous acid, tris(nonyl-and /or dimonylphenyl) ester
SML = 30 mg/kg
89
77440
Polyethyleneglycol diricinoleate
SML = 42 mg/kg
90
77520
61791-12-6
Polyethyleneglycol ester of castor oil
SML = 42 mg/kg
91
78320
09004-97-1
Polyethyleneglycol monoricinoleate
SML = 42 mg/kg
92
81200
71878-19-8
Poly[6-[(1,1,3,3-tetramethylbutyl) amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl)limino]
SML = 3 mg/kg
93
81680
07681-11-0
Potassium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium)
94
82020
19019-51-3
Propionic acid, cobalt salt
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
95
83595
119345-01-6
Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2, 4-di-tert-butylphenol with friedel craft reaction product of phosphorus trichloride and biphenyl
SML = 18 mg/kg and in compliance with the specifications in Schedule 2B
96
83700
00141-22-0
Ricinoleic acid
SML = 42 mg/kg
97
84800
00087-18-3
Salicylic acid, 4-tert-butylphenyl ester
SML = 12 mg/kg
98
84880
00119-36-8
Salicylic acid, methyl ester
SML = 30 mg/kg
99
85760
12068-40-5
Silicic acid, lithium aluminium salt (2:1:1)
SML(T) = 0.6 mg/kg (8) (expressed as lithium)
100
85920
12627-14-4
Silicic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)
101
86800
07681-82-5
Sodium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium)
102
86880
Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate
SML = 9 mg/kg
103
89170
13586-84-0
Stearic acid, cobalt salt
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
104
92000
07727-43-7
Sulphuric acid, barium salt
SML(T) = 1 mg/kg (11) (expressed as barium)
105
92320
Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid
SML = 15 mg/kg
106
92560
38613-77-3
Tetrakis(2,4-di-tert-butyl-phenyl)-4-4’-biphenylylene diphosphonite
SML = 18 mg/kg
107
92800
00096-69-5
4,4’-Thiobis(6-tert-butyl-3-methylphenol)
SML = 0.48 mg/kg
108
92880
41484-35-9
Thiodiethanol bis(3-(3-5-di-tert-butyl-4-hydroxyphenyl)propionate)
SML = 2.4 mg/kg
109
93120
00123-28-4
Thiodipropionic acid, didodecyl ester
SML(T) = 5 mg/kg (20)
110
93280
00693-36-7
Thiodipropionic acid, dioctadecyl ester
SML(T) = 5 mg/kg (20)
111
94560
00122-20-3
Triisopropanolamine
SML = 5 mg/kg
112
95280
40601-76-1
1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
SML = 6 mg/kg
114
95600
01843-03-4
1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane
SML = 5 mg/kg
SCHEDULE 3LIST OF SUBSTANCES TO BE ADDED TO SCHEDULE 2B TO THE PRINCIPAL REGULATIONS
Item |
PM/REF No. |
Specifications |
---|---|---|
4A |
43680— |
CHLORODIFLUOROMETHANE Content of chlorofluoromethane less than 1 mg/kg of the substance |
4B |
47210— |
DIBUTYLTHIOSTANNOIC ACID POLYMER Molecular unit = (C8H18S3Sn2)n (n = 1,5-2) |
5A |
83595 |
REACTION PRODUCT OF DI-TERT-BUTYLPHOSPHONITE WITH BIPHENYL, OBTAINED BY CONDENSATION OF 2,4-DI-TERT- BUTYLPHENOL WITH FRIEDEL CRAFT REACTION PRODUCT OF PHOSPHORUS TRICHLORIDE AND BIPHENYL Composition —4,4’-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 38613-77-3) (36—46% w/w (1)) —4,3’- Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-00-4) (17—23% w/w) —3,3’- Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 118421-01-5) (1—5% w/w) —4-Biphenylene-0,0-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No. 91362-37-7) (11—19% w/w) —Tris(2,4-di-tert-butylphenyl)phosphite (CAS No. 31570-04-4) (9—18% w/w) —4,4’-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No. 112949-970) (5% w/w) Other specifications —Phosphor content of minimum 5.4% to 5.9% —Acid value of maximum 10 mg KOH per gram —Melt range of 85—110°C |
1990 c.16.