Statutory Instruments
1996 No. 2635
CONSUMER PROTECTION
The Dangerous Substances and Preparations (Safety) (Consolidation) (Amendment) Regulations 1996
Made
15th October 1996
Laid before Parliament
16th October 1996
Coming into force
11th November 1996
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1), consulted such organisations as appear to him to be representative of interests substantially affected by these Regulations, such other persons as he considers appropriate and the Health and Safety Commission:
Now, therefore, the Secretary of State in exercise of powers conferred upon him by section 11 of the said Act of 1987 hereby makes the following Regulations:—
1. These Regulations may be cited as the Dangerous Substances and Preparations (Safety) (Consolidation) (Amendment) Regulations 1996 and shall come into force on 11th November 1996.
2. The Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994(2) are amended as follows:—
(a)by substituting the following for regulation 1(2)—
“(2) In these Regulations—
“the approved supply list” shall have the same meaning as in regulation 2(1) of the CHIP Regulations;
“the CHIP Regulations” means in Great Britain the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994(b) and in Northern Ireland the Chemicals (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 1995(c);
“medicinal product” means—
(a)
a medicinal product—
(i)
which is a “relevant medicinal product” within the meaning of regulation 1(2) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(d), or
(ii)
in respect of which there is for the time being a clinical trial certificate as defined in section 31(3) of the Medicines Act 1968(e), or
(iii)
in respect of which there is for the time being an exemption conferred by article 3 of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995(f), or
(iv)
in respect of which there is for the time being a certificate of registration granted under regulation 5 of the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994(g); or
an article or substance to which provisions of the Medicines Act 1968 apply by virtue of an order made under section 104 or 105 of that Act;
“motor fuel” has the same meaning as in regulation 3(1) of the Motor Fuel (Composition and Content) Regulations 1994(h);
“the prescribed concentration” of any substance means either—
(a)
the concentration specified in the approved supply list; or
(b)
where no concentration limit for that substance is specified in the approved supply list, the concentration specified in paragraph 6 (Table VI or Table VIA) of Part II of Schedule 3 to the CHIP Regulations;
“supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply; and
“veterinary product” means—
(a)
a medicinal product which is supplied in accordance with an animal test certificate within the meaning of section 32(2)(b) of the Medicines Act 1968(e), or
(b)
a product supplied for administration in accordance with regulation 5(1)(c) of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994(i).””
and by adding the following corresponding footnotes—
“(b) S.I. 1994/3247, amended by S.I. 1996/1092.
(c) S.R. 1995 No. 60.
(d) S.I. 1994/3144.
(e) 1968 c. 67.
(f) S.I. 1995/2808.
(g) S.I. 1994/105, amended by S.I. 1994/889, 1995/541 and 1996/482.
(h) S.I. 1994/2295.
(i) S.I. 1994/2987.”;
(b)by adding the following after regulation 2—
“2A. Regulations 6A, 6B and 6C below shall not apply to—
(a)a medicinal product;
(b)a veterinary product;
(c)a cosmetic product within the meaning of regulation 2(1) of the Cosmetic Products (Safety) Regulations 1989(f);
(d)motor fuel which complies with the relevant requirements of regulation 5 of the Motor Fuel (Composition and Content) Regulations 1994(g);
(e)mineral oil products intended for use as fuel in mobile or fixed combustion plants;
(f)fuels sold in closed systems; or
(g)artists' paints.” and by adding the following corresponding footnotes—
“(f) S.I. 1989/2233.
(g) S.I. 1994/2295.”;
(c)in regulation 3(2) by deleting the words which follow the words “dangerous for supply”—'', by substituting therefor the words “within the meaning of the CHIP Regulations.” and by deleting the corresponding footnote;
(d)by adding the following after regulation 6—
“Carcinogens
6A. Subject to regulation 2A above, no person shall supply to any member of the general public or supply to any person for the purposes of sale to the general public any substance or any preparation containing any substance which is—
(a)listed in Schedule 2 to these Regulations under the heading “Carcinogenic substances of Category 1” or “Carcinogenic substances of Category 2”; and
(b)required under the CHIP Regulations to be labelled “toxic (T)” or “very toxic (T+)” together with standard risk phrase R45 (“may cause cancer”) or R49 (“may cause cancer by inhalation”) (or which would be required to be so labelled but for any of the exceptions contained in sub-paragraphs (a), (f), (n) and (o) of regulation 3(1) of those Regulations), where the concentration of the said substance is equal to or greater than the prescribed concentration for that substance.
Mutagens
6B. Subject to regulation 2A above, no person shall supply to any member of the general public or supply to any person for the purposes of sale to the general public any substance or any preparation containing any substance which is—
(a)listed in Schedule 2 to these regulations under the heading “Mutagenic substances of Category 1” or “Mutagenic substances of Category 2”; and
(b)required under the CHIP Regulations to be labelled with standard risk phrase R46 (“may cause heritable genetic damage”) (or which would be required to be so labelled but for any of the exceptions contained in sub-paragraphs (a), (f), (n) and (o) of regulation 3(1) of those Regulations), where the concentration of the said substance is equal to or greater than the prescribed concentration for that substance.
Substances toxic for reproduction
6C. Subject to regulation 2A above, no person shall supply to any member of the general public or supply to any person for the purposes of sale to the general public any substance or any preparation containing any substance which is—
(a)listed in Schedule 2 to these Regulations under the heading “Toxic for reproduction substances of Category 1” or “Toxic for reproduction substances of Category 2”; and
(b)required under the CHIP Regulations to be labelled with standard risk phrase R60 (“may impair fertility”) or R61 (“may cause harm to the unborn child”) or both R60 and R61 (or which would be required to be so labelled but for any of the exceptions contained in sub-paragraphs (a), (f), (n) and (o) of regulation 3(1) of those Regulations), where the concentration of the said substance is equal to or greater than the prescribed concentration for that substance.
Chlorinated solvents
6D.—(1) Subject to paragraph (2) below, no person shall supply to any member of the general public or supply to any person for the purposes of sale to the general public any substance or preparation containing any of the following in concentrations equal to or greater than 0.1% by mass—
(a)chloroform (CAS No. 67-66-3)(a);
(b)carbon tetrachloride (CAS No. 56-23-5);
(c)1,1,2 — trichloroethane (CAS No. 79-00-5);
(d)1,1,2,2 — tetrachloroethane (CAS No. 79-34-5);
(e)1,1,1,2 — tetrachloroethane (CAS No. 630-20-6);
(f)pentachloroethane (CAS No. 76-01-7);
(g)1,1 — dichloroethylene (CAS No. 75-35-4);
(h)1,1,1 — trichloroethane (CAS No. 71-55-6)
(2) Paragraph (1) above shall not apply to—
(a)a medicinal product;
(b)a veterinary product; or
(c)a cosmetic product within the meaning of regulation 2(1) of the Cosmetic Products (Safety) Regulations 1989(b).”;
(e)by adding the following corresponding footnotes in relation to regulation 6D—
“(a)“CAS Nos.” are the numbers assigned to the substances by the Chemical Abstracts Service.
(b)S.I. 1989/2233.”;
(f)by re-numbering the Schedule as Schedule 1; and
(g)by adding as Schedule 2 the contents of the Schedule to these Regulations.
John M. Taylor,
Parliamentary Under-Secretary of State for Corporate and Consumer Affairs,
Department of Trade and Industry
15th October 1996
Regulation 2(g)
SCHEDULE
Regulations 6A, 6B and 6C
“SCHEDULE 2
Substances referred to in regulations 6A, 6B and 6C
Substance
CAS Number
NOTE
The CAS Number is the number assigned to the substance by the Chemicals Abstract Service.”
Carcinogenic substances of Category 1
2-naphthylamine; β-naphthylamine
91-59-8
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
92-67-1
benzidine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamine
92-87-5
chromium trioxide
1333-82-0
arsenic acid and its salts
——
arsenic pentoxide; arsenic oxide
1303-28-2
diarsenic trioxide; arsenic trioxide
1327-53-3
asbestos
132207-33-1
132207-32-0
12172-73-5
77536-66-4
77536-68-6
77536-67-5
benzene
71-43-2
bis(chloromethyl) ether
542-88-1
chloromethyl methyl ether; chlorodimethyl ether
107-30-2
dinickel trioxide
1314-06-3
erionite
12510-42-8
nickel dioxide
12035-36-8
nickel monoxide
1313-99-1
nickel subsulphide; trinickel disulphide
12035-72-2
nickel sulphide
16812-54-7
salts of 2-naphthylamine
——
salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenyl
——
salts of benzidine
——
vinyl chloride; chloroethylene
75-01-4
zinc chromates, including zinc potassium chromate
——
Carcinogenic substances of Category 2
1-methyl-3-nitro-1-nitrosoguanidine
70-25-7
1,2-dibromo-3-chloropropane
96-12-8
1,2-dimethylhydrazine
540-73-8
1,3-butadiene; buta-1,3-diene
106-99-0
1,3-dichloro-2-propanol
96-23-1
1,3-propanesultone
1120-71-4
3-propanolide; 1,3-propionolactone
57-57-8
1,4-dichlorobut-2-ene
764-41-0
2-nitronaphthalene
581-89-5
2-nitropropane
79-46-9
2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylenebis(2-chloroaniline)
101-14-4
2-2'-(nitrosoimino)bisethanol
1116-54-7
3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamine
91-94-1
3,3'-dimethoxybenzidine; o-dianisidine
119-90-4
3,3'-dimethylbenzidine; o-tolidine
119-93-7
4-aminoazobenzene
60-09-3
4-amino-3-fluorophenol
399-95-1
4-methyl-m-phenylenediamine
95-80-7
4-nitrobiphenyl
92-93-3
4,4'-methylenedi-o-toluidine
838-88-0
4,4'-diaminodiphenylmethane; 4,4'-methylenedianiline
101-77-9
5-nitroacenaphthene
602-87-9
4-o-tolyazo-o-toluidine; 4-amino-2',3-dimethylazobenzene; fast garnet GBC base, AAT; o-aminoazotoluene
97-56-3
disodium-{5[4'-((2,6-hydroxy-3-((2-hydroxy-5-sulphophenyl)azo)phenyl)azo)(1,1'-biphenyl)-4-yl)azo]salicylato(4-)}cuprate(2-);C1 Direct Brown 95
16071-86-6
cadmium oxide
1306-19-0
Extracts (petroleum), heavy naphthenic distillate solvent
64742-11-6
Extracts (petroleum), heavy paraffinic distillate solvent
64742-04-7
Extracts (petroleum), light naphthenic distillate solvent
64742-03-6
Extracts (petroleum), light paraffinic distillate solvent
64742-05-8
Extracts (petroleum), light vacuum gas oil solvent
91995-78-7
Hydrocarbons, C26-55, aromatic rich
97722-04-8
N,N-dimethylhydrazine
57-14-7
acrylamide
79-06-1
acrylonitrile
107-13-1
α,α,α-trichlorotoluene; benzotrichloride
98-07-7
benz[a]anthracene
56-55-3
benzo[a]pyrene; benzo[d,e,f]chrysene
50-32-8
benzo[b]fluoranthene; benzo[e]acephenanthrylene
205-99-2
benzo[j]fluoranthene
205-82-3
benzo[k]fluoranthene
207-08-9
beryllium
7440-41-7
beryllium compounds, with the exception of aluminium beryllium silicates
——
cadmium chloride
10108-64-2
cadmium sulphate
10124-36-4
calcium chromate
13765-19-0
captafol (ISO); 1,2,3,6-tetrahydro-N-(1,1,2,2-tetrachloroethylthio)phthalimide
2425-06-1
carbadox (INN); methyl-3-(quinoxalin-2-ylmethylene)carbazate1,4-dioxide; 2-(methoxycarbonylhydrazonomethyl)quinoxaline 1,4-dioxide
6804-07-5
chromium (III) chromate; chromic chromate
24613-89-6
diazomethane
334-88-3
dibenz[a,h]anthracene
53-70-3
diethyl sulphate
64-67-5
dimethyl sulphate
77-78-1
dimethylcarbamoyl chloride
79-44-7
N-nitrosodimethylamine; dimethylnitrosamine
62-75-9
dimethylsulfamoyl chloride
13360-57-1
1-chloro-2,3-epoxypropane; epichlorohydrin
106-89-8
1,2-dichloroethane; ethylene dichloride
107-06-2
ethylene oxide; oxirane
75-21-8
ethyleneimine; aziridine
151-56-4
hexachlorobenzene
118-74-1
hexamethylphosphoric triamide; hexamethylphosphoramide
680-31-9
hydrazine
302-01-2
hydrazobenzene; 1,2-diphenylhydrazine
122-66-7
methyl acrylamidomethoxyacetate (containing≥0.1% acrylamide)
77402-03-0
methyl-ONN-azoxymethyl acetate
592-62-1
nitrofen (ISO); 2,4-dichlorophenyl 4-nitrophenyl ether
1836-75-5
nitrosodipropylamine
621-64-7
2-methoxyaniline; o-anisidine
90-04-0
potassium bromate
7758-01-2
propylene oxide; 1,2-epoxypropane; methyloxirane
75-56-9
o-toluidine
95-53-4
2-methylaziridine; propyleneimine
75-55-8
salts of 2,2'-dichloro-4,4'-methylenedianiline; salts of 4,4'-methylenebis(2-chloroaniline)
——
salts of 3,3'-dichlorobenzidine; salts of 3,3'-dichlorobiphenyl-4,4'-ylenediamine
——
salts of 3,3'-dimethoxybenzidine; salts of o-dianisidine
——
salts of 3,3'-dimethylbenzidine; salts of o-tolidine
——
strontium chromate
7789-06-2
styrene oxide; (epoxyethyl)benzene; phenyloxirane
96-09-3
sulfallate (ISO); 2-chlorallyl diethyldithiocarbamate
95-06-7
thioacetamide
62-55-5
urethane (INN); ethyl carbamate
51-79-6
Mutagenic substances of Category 1
There are no substances classified in this category
Mutagenic substances of Category 2
1,2-dibromo-3-chloropropane
96-12-8
acrylamide
79-06-1
benzo[a]pyrene; benzo[d,e,f]chrysene
50-32-8
diethyl sulphate
64-67-5
ethylene oxide; oxirane
75-21-8
ethyleneimine, aziridine
151-56-4
hexamethylphosphoric triamide; hexamethylphosphoramide
680-31-9
methyl acrylamidomethoxyacetate (containing ≥0.1% acrylamide)
77402-03-0
Toxic for reproduction substances of Category 1
lead hexafluorosilicate
25808-74-6
lead acetate
1335-32-6
lead alkyls
——
lead azide
13424-46-9
lead chromate
7758-97-6
lead compounds, with the exception of those specified elsewhere in this Part of this Schedule
——
lead di(acetate)
301-04-2
lead 2,4,6-trinitroresorcinoxide; lead styphnate
15245-44-0
lead(II) methanesulfonate
17570-76-2
trilead bis(orthophosphate)
7446-27-7
warfarin (ISO); 4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin
81-81-2
Toxic for reproduction substances of Category 2
2-ethoxyethanol; ethylene glycol monoethyl ether
110-80-5
2-ethylhexyl [3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl methylthio]acetate
80387-97-9
2-methoxyethanol; ethylene glycol monomethyl ether
109-86-4
benzo[a]pyrene; benzo[d,e,f]chrysene
50-32-8
binapacryl (ISO); 2-sec butyl-4,6-dinitrophenyl-3-methylcrotonate
485-31-4
N,N-dimethylformamide; dimethyl formamide
68-12-2
dinoseb (ISO); 6-sec butyl-2,4-dinitrophenol
8-85-7
dinoterb (ISO); 2-tert-butyl-4,6-dinitrophenol
1420-07-1
ethylenethiourea; imidazolidine-2-thione; 2-imidazoline-2-thiol
96-45-7
2-ethoxyethyl acetate; ethylglycol acetate
111-15-9
methyl-ONN-azoxymethyl acetate
592-62-1
2-methoxyethyl acetate; methylglycol acetate
110-49-6
nickel tetracarbonyl
13463-39-3
nitrofen (ISO); 2,4-dichlorophenyl 4-nitrophenyl ether
1836-75-5
salts and esters of dinoseb (ISO)
——
salts and esters of dinoterb (ISO)
——
Explanatory Note
(This note is not part of the Regulations)
These Regulations amend the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994 (S.I. 1994/2844) (“the principal Regulations”). They implement part of Council Directive 94/60/EC (O.J. No. L365, 31.12.1994, p.1), which amended for the fourteenth time Council Directive 76/769/EEC.
The Regulations amend the principal Regulations to prohibit the supply to the general public and the supply to any person for sale to the general public of certain carcenogenic and mutagenic substances, and certain substances toxic for reproduction, in specified concentrations. The supply of preparations containing such substances is also prohibited. The Regulations provide exceptions for medicinal and veterinary products, cosmetics, motor fuel mineral oil products intended for use as fuel in mobile or fixed combustion plants, fuels, sold in closed systems and artists' paints (regulation 2(b), (d) and (g) and the Schedule).
The Regulations also amend the principal Regulations to prohibit the supply to the general public and the supply to any person for sale to the general public of substances and preparations containing certain specified chlorinated solvents in concentrations equal to or greater than 0.1 per cent by mass. There are exceptions for medicinal and veterinary products and cosmetics (regulation 2(d)).
A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs and Competition Policy Directorate of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London SW1H 0ET.
(1)
1987 c. 43.
(2)
S.I. 1994/2844.
