S.I. No. 194/2010 - European Communities (Cosmetic Products) (Amendment) Regulations 2010.

1. Part 1 of Schedule 3 to the Principal Regulations is amended by the insertion, after reference number 206 (inserted by paragraph 2(3) of Schedule 6), of the following reference number and footnote

Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Field of applicationand/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

“207

Ethyl Lauroyl Arginate HCl (INCI) (*) Ethyl-Na-dodecanoyl- L-arginate hydrochloride CAS No 60372-77-2 EC No 434-630-6

(

a

) soap(

b

) anti-dandruff shampoos (c) deodorants, not in form of spray

0,8 %

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

(*) For use as a preservative, see reference number 58 in Part 1 of Schedule 6.”.

2. Part 1 of Schedule 6 to the Principal Regulations is amended by the insertion, after reference number 57, of the following reference number and footnote

Referencenumber

Substance

Maximum authorised concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

c

d

e

“58

Ethyl Lauroyl Arginate HCl (INCI) (O) (**) Ethyl- —dodecanoyl- L-arginate hydrochloride CAS No 60372-77-2 EC No 434-630-6

0.4%

Not to be used in lip products, oral products and spray products.

(**) For uses other than as a preservative, see reference number 207 in Part 1 of Schedule 3 ”.

GIVEN under my Official Seal,

6 May 2010.

MARY HARNEY,

Minister for Health and Children.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations amend the European Communities (Cosmetic Products) Regulations 2004 to 2009. They update the law in relation to the manufacture, marketing and sale of cosmetic products by the implementation of Commission Directives 2009/129/EC, 2009/130/EC, 2009/134/EC, 2009/159/EU, 2009/164/EU and 2010/3/EU and Directive 2008/112/EC of the European Parliament and of the Council with a view to improving the safety of those products. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2010.

1 OJ No. L267, 10.10.2009, p18

2 OJ No. L268, 13.10.2009, p6

3 OJ No. L282, 29.10.2009, p15

4 OJ No. L336, 18.12.2009, p29

5 OJ No. L344, 23.12.2009, p41

6 OJ No. L29, 2.2.2010, p5

7 OJ No. L345, 23.12.2008, p68

8 OJ No. L142, 31.05.2008, p1

9 OJ No. L220, 24.8.2009, p1

10 OJ. No. L396, 30.12.2006, p1

11 OJ No. L353, 31.12.2008, p1

3. Schedule 9 to the Principal Regulations is amended—

(

a

) by the deletion of Part 1, and

(

b

) by the substitution, for the first sentence of Part 2, of the following sentence

“This Part lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of the Directive and which are not listed in Regulation (EC) No 440/2008.”.

SCHEDULE 2

Amendment of Principal Regulations to give effect to Commission Directive 2009/129/EC of 9 October 2009

Column f of reference numbers 26 to 43, 47 and 56 in Part 1 of Schedule 3 to the Principal Regulations is amended by the substitution, for the text after the first sentence, of the following text

“The following labelling is obligatory for any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15 % calculated as Fluorine, unless the toothpaste is already labelled as contra-indicated for children (e.g. ‘For adult use only’)

‘Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources, consult a dentist or doctor.’”.

SCHEDULE 3

Amendment of Principal Regulations to give effect to Commission Directive 2009/130/EC of 12 October 2009

Part 1 of Schedule 3 to the Principal Regulations is amended—

(1) in column b of reference number 8, by the substitution, for the existing text, of the following text

“N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine 1 , with the exception of those derivatives listed elsewhere in this Schedule and under reference numbers 1309, 1311, and 1312 in Schedule 2”,

(2) subject to paragraphs 1(1) and 1(4) of Schedule 4, by the insertion of the following reference number after reference number 8

Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Field of applicationand/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

“8a

p-Phenylene-diamine and its salts 1 CAS No 106-50-3Einecs 203-404-7p-Phenylene-diamine HCl CAS No 624-18-0 Einecs 210-834-9 p-Phenylene-diamine sulphateCAS No 16245-77-5Einecs 240-357-1

Hair dye substance in oxidative hair dye products(

a

) general use(

b

) profess-ional use

(

a

) and (

b

) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base.

(

a

) Can cause an allergic reaction. Contains phenylene-diamines. Do not use to dye eyelashes or eyebrows.(

b

) For professional use only. Contains phenylene-diamines. Can cause an allergic reaction. Wear suitable gloves.”,

(3) in column b of reference number 9, by the substitution, for the existing text, of the following text

“Methylphenylenediamines, their N-substituted derivatives and their salts 1 , with the exception of a substance mentioned in reference number 9a in this Schedule and substances under reference numbers 364, 1310 and 1313 in Schedule 2”,

(4) subject to subparagraphs (3) and (4) of paragraph 1 of Schedule 4, by the insertion of the following reference number after reference number 9

Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Field of applicationand/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

“9a

Toluene-2,5-diamine and its salts 1 CAS No 95-70-5Einecs 202-442-1Toluene-2,5-diamine sulphate CAS No 615-50-9Einecs 210-431-8

Hair dye substance in oxidative hair dye products (

a

) general use(

b

) profess-ional use

(

a

) and (

b

) After mixing under oxidative conditions, the maximum concentration applied to hair must not exceed 4 % calculated as free base.

As mentioned in reference number 9, column f.”,

and

(5) in reference number 14, by the deletion—

(i) in column d, of “0.3%”, and

(ii) in column f, of paragraph (

a

).

SCHEDULE 4

Amendment of Principal Regulations to give effect to Commission Directive 2009/134/EC of 28 October 2009

4. In these Regulations, “Principal Regulations” means the European Communities (Cosmetic Products) Regulations 2004 (

S.I. No. 870 of 2004

), as amended.

Amendment of Regulation 4(1) of Principal Regulations

5. The definition of “Directive” in Regulation 4(1) of the Principal Regulations is amended by the addition to it of references to Commission Directives 2009/129/EC, 2009/130/EC, 2009/134/EC, 2009/159/EU, 2009/164/EU and 2010/3/EU and Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008.

Further Amendments

6. Subject to Regulation 3, the Principal Regulations are further amended as provided for in the Schedules.

SCHEDULE 1

Amendment of Principal Regulations to give effect to certain provisions of Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

11

th May

, 2010.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by

section 3

of the

European Communities Act 1972

(No. 27 of 1972) and for the purpose of giving effect to Commission Directives 2009/129/EC

1

of 9 October 2009, 2009/130/EC

2

of 12 October 2009, 2009/134/EC

3

of 28 October 2009, 2009/159/EU

4

of 16 December 2009, 2009/164/EU

5

of 22 December 2009 and 2010/3/EU

6

of 1 February 2010 and to Directive 2008/112/EC

7

of the European Parliament and of the Council of 16 December 2008, hereby make the following regulations

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