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Maltese Laws |
PRODUCT SAFETY ACT (CAP. 427)
Cosmetic Products (Amendment) Regulations, 2006
IN exercise of the powers conferred by article 39 of the Product Safety Act, the Minister for Competitiveness and Communications has,
on the advice of the Malta Standards Authority, made the following regulations>–
1. The title of these regulations is the Cosmetic Products (Amendment) Regulations, 2006, and they shall be read and construed
as one with the Cosmetic Products Regulations, 2004 hereinafter referred to as “the principal regulations”.
2. As from the 20th January, 2006, cosmetic products that fail to comply with the provisions of these regulations shall not be
placed on the market by manufacturers or importers.
3. These regulations implement the provisions of Commission
Directive 2005#52#EC of the 9th September, 2005.
4. For Part 2 of the Third Schedule to the principal regulations, there shall be substituted the following>–
Citation and coming into force.
L.N. 424 of 2004
.
Scope.
Amends the Third Schedule to the principal regulations.
“PART 2
List of Substances provisionally allowed
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
1 | Basic Blue 7 (CAS No 2390-60-5) | Non-oxidising colouring agents for hair dyeing | 0.2 % | Can cause allergic reaction | 31.08.2006 | |
2 | 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 3.0 % (b) 3.0 % 50 | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.5 % | (a) (b) Can cause allergic reaction | 31.08.2006 |
3 | 4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 3.0 % (b) 3.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.5 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
4 | 2,7-Naphthalenediol (CAS no 582-17-2) and its salts | Oxidising colouring agents for hair dyeing | 1.0 % | In combination with hydrogen peroxide the maximum use concentration upon | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
application is 0.5 % | ||||||
5 | m-Aminophenol (CAS no 591-27-5) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
6 | 2,6-Dihydroxy-3,4- dimethylpyridine (CAS No 84540-47-6) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
7 | 4-Hydroxypropylamino- 3-nitrophenol (CAS No 92952-81-3) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 5.2 % (b) 2.6 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 2.6 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
8 | 6-Nitro-2,5- pyridinediamine (CAS No 69825-83-8) and its salts | Non-oxidising colouring agent for hair dyeing | 3.0 % | Can cause allergic reaction | 31.08.2006 | |
9 | HC Blue No 11 (CAS No 23920-15-2) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for | (a) 3.0 % (b) 2.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.5 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
hair dyeing | ||||||
10 | Hydroxyethyl-2- nitro-p-toluidine (CAS No 100418-33-5) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 1.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
11 | 2-Hydroxyethylpicramic acid (CAS No 99610-72- 7) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 3.0% (b) 2.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.5 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
12 | p-Methylaminophenol (CAS No 150-75-4) and its salts | Oxidising colouring agent for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | Can cause allergic reaction | 31.12.2006 |
13 | 2,4-Diamino-5- methylphenoxyethanol (CAS No 141614-05-3) and its salts | Oxidising colouring agent for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | Can cause allergic reaction | 31.08.2006 |
14 | HC Violet No 2 CAS No 104226-19-9) and its salts | Non-oxidising colouring agent for hair dyeing | 2.0 % | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
15 | Hydroxyethyl-2,6- dinitro-p-anisidine (CAS No 122252-11-3) and its salts | Non-oxidising colouring agent for hair dyeing | 3.0 % | Can cause allergic reaction | 31.08.2006 | |
16 | HC Blue No 12 (CAS No 104516-93-0) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 1.5 % (b) 1.5 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 0.75 % | (a) (b) Can cause allergic reaction | 31.12.2006 |
17 | 2,4-Diamino-5- methylphenetol CAS No 113715-25-6) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.08.2006 |
18 | 1,3-Bis-(2,4- diaminophenoxy) propane (CAS No 81892-72-0) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
19 | 3-Amino-2,4- dichlorophenol (CAS No 61693-43-4) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
20 | Phenyl methyl pyrazolone (CAS No 89- 25-8) and its salts | Oxidising colouring agents for hair dyeing | 0.5 % | In combination with hydrogen peroxide the maximum use | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
concentration upon application is 0.25 % | ||||||
21 | 2-Methyl-5- hydroxyethylaminophenol (CAS No 55302-96-0) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
22 | Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | Can cause allergic reaction | 31.12.2006 |
23 | 1,7-Naphthalenediol (CAS No 575-38-2) and its salts | Oxidising colouring agents for hair dyeing | 1.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 % | Can cause allergic reaction | 31.08.2006 |
24 | HC Yellow No 10 (CAS No 109023-83-8) and its salts | Non-oxidising colouring agents for hair dyeing | 0.2 % | 31.12.2006 | ||
25 | 2,6-Dimethoxy-3,5- pyridinediamine (CAS No 85679-78-3) and its salts | Oxidising colouring agents for hair dyeing | 0.5 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 % | Can cause allergic reaction | 31.12.2006 |
26 | HC Orange No 2 (CAS No 85765-48-6) and its salts | Non-oxidising colouring agents for hair dyeing | 1.0 % | 31.12.2006 | ||
27 | HC Violet No 1 (CAS No | (a) Oxidising | (a) 0.5 % | In combination with | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
82576-75-8) and its salts | colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (b) 0.5 % | hydrogen peroxide the maximum use concen- tration upon application is 0.25 % | |||
28 | 3-Methylamino-4- nitro-phenoxyethanol (CAS No 59820-63-2) and its salts | Non-oxidising colouring agents for hair dyeing | 1.0 % | 31.12.2006 | ||
29 | 2-Hydroxy-ethylamino- 5-nitroanisole (CAS No 66095-81-6) and its salts | Non-oxidising colouring agents for hair dyeing | 1.0 % | 31.12.2006 | ||
30 | 2-Chloro-5-nitro-N- hydroxyethyl-p- phenylene-diamine (CAS No 50610-28-1) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 1.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | 31.08.2006 | |
31 | HC Red No 13 (CAS No 94158-13-1) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.5 % (b) 2.5 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.25 % | 31.12.2006 | |
32 | 1,5-Naphthalenediol | Oxidising colouring | 1.0 % | In combination with | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
(CAS No 83-56-7) and its salts | agents for hair dyeing | hydrogen peroxide the maximum use concentration upon application is 0.5 % | ||||
33 | Hydroxypropyl bis N-hydroxyethyl- pphenylenediamine) CAS No 128729-30-6) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | Can cause allergic reaction | 31.12.2006 |
34 | o-Aminophenol (CAS No 95-55-6) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | 31.08.2006 | |
35 | 4-Amino-2- hydroxytoluene (CAS No 2835-95-2) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.12.2006 | |
36 | 2,4- Diaminophenoxyethanol (CAS No 66422-95-5) and its salts | Oxidising colouring agents for hair dyeing | 4.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 2.0 % | 31.12.2006 | |
37 | 2-Methylresorcinol (CAS No 608-25-3) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
concentration upon application is 1.0 % | ||||||
38 | 4-Amino-m-cresol (CAS No 2835-99-6) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.12.2006 | |
39 | 2-Amino-4- hydroxyethylaminoanisol e CAS No 83763-47-7) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.12.2006 | |
40 | 3,4-Diaminobenzoicacid (CAS No 619-05-6) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | 31.08.2006 | |
41 | 6-Amino-o-cresol (CAS No 17672-22-9) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.08.2006 | |
42 | 2-Aminomethyl- paminophenol (CAS No 79352-72-0) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.08.2006 | |
43 | Hydroxyethylamino- methyl-paminophenol | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the | 31.08.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
(CAS No 110952-46-0) and its salts | maximum use concentration upon application is 1.5 % | |||||
44 | Hydroxyethyl-3,4- methylenedioxyaniline (CAS No 81329-90-0) and its salts | Oxidising colouring agents for hair dyeing | 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.12.2006 | |
45 | Acid Black 52 (CAS No 3618-58-4) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | 31.08.2006 | |
46 | 2-Nitro-p- phenylenediamine (CAS No 5307-14-2) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 0.3 % (b) 0.3 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 0.15 % | 31.08.2006 | |
47 | HC Blue No 2 (CAS No 33229-34-4) and its salts | Non-oxidising colouring agents for hair dyeing | 2.8 % | 31.12.2006 | ||
48 | 3-Nitro-p- hydroxyethylaminophenol (CAS No 65235-31-6) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising | (a) 6.0 % (b) 6.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application | 31.12.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
colouring agents for hair dyeing | is 3.0 % | |||||
49 | 4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 0.5 % (b) 0.5 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 0.25 % | 31.12.2006 | |
50 | HC Red No 10 + HC Red No 11 (CAS No 95576- 89-9 + 95576-92-4) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 1.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | 31.12.2006 | |
51 | Yellow No 6 (CAS No 104333-00-8) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 1.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | 31.08.2006 | |
52 | HC Yellow No 12 (CAS No 59320-13-7) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 1.0 % (b) 0.5 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 0.5 % | 31.08.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
53 | HC Blue No 10 (CAS No 102767-27-1) and its salts | Oxidising colouring agents for hair dyeing | 2.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.0 % | 31.08.2006 | |
54 | HC Blue No 9 (CAS No 114087-47-1) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 1.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | 31.08.2006 | |
55 | 2-Chloro-6-ethylamino- 4-nitrophenol (CAS No 131657-78-8) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 3.0 % (b) 3.0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 % | 31.12.2006 | |
56 | 2-Amino-6-chloro- 4-nitrophenol (CAS No 6358-09-4) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 2.0 % (b) 2.0 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 1.0 % | 31.12.2006 | |
57 | Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts | (a) Oxidising colouring agents for hair dyeing | (a) 0.5 % | In combination with hydrogen peroxide the maximum use concen- tration upon | 31.08.2006 |
Reference Number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
A | B | C | D | E | F | G |
(b) Non-oxidising colouring agents for hair dyeing | (b) 0.5 % | application is 0.25 % | ||||
58 | Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts | Non-oxidising colouring agents for hair dyeing | 2.0 % | 31.12.2006 | ||
59 | Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts | Non-oxidising colouring agents for hair dyeing | 2.0 % | 31.08.2006 | ||
60 | Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts | (a) Oxidising colouring agents for hair dyeing (b) Non-oxidising colouring agents for hair dyeing | (a) 0.3 % (b) 0.3 % | In combination with hydrogen peroxide the maximum use concen- tration upon application is 0.15 % | 31.08.2006 |
”.
Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta
Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press
Prezz 28ç – Price 28c
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