ARCHIVED — Vol. 148, No. 43 — October 25, 2014

Warning This Web page has been archived on the Web.

Archived Content

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

GOVERNMENT NOTICES

DEPARTMENT OF CITIZENSHIP AND IMMIGRATION

IMMIGRATION AND REFUGEE PROTECTION ACT

Order Amending the Order Designating Countries of Origin

Whereas, pursuant to paragraph 109.1(2)(a) (see footnote a) of the Immigration and Refugee Protection Act (see footnote b), the number of claims for refugee protection made in Canada by nationals of each of the countries set out in section 1 of the annexed Order Amending the Order Designating Countries of Origin in respect of which the Refugee Protection Division has made a final determination is equal to or greater than the number provided in the Order Establishing Quantitative Thresholds for the Designation of Countries of Origin and the conditions set out in subparagraph 109.1(2)(a)(i) (see footnote c) or (ii) (see footnote d) of the Act are met with respect to those claims for refugee protection;

And whereas, pursuant to paragraph 109.1(2)(b) (see footnote e) of the Immigration and Refugee Protection Act (see footnote f), the number of claims for refugee protection made in Canada by nationals of each of the countries set out in section 2 of the annexed Order in respect of which the Refugee Protection Division has made a final determination is less than the number provided for in the Order Establishing Quantitative Thresholds for the Designation of Countries of Origin (see footnote g) and the Minister of Citizenship and Immigration is of the opinion that those countries meet the criteria set out in subparagraphs 109.1(2)(b)(i)(see footnote h) to (iii) (see footnote i) of that Act;

Therefore, the Minister of Citizenship and Immigration, pursuant to subsection 109.1(1) (see footnote j) of the Immigration and Refugee Protection Act (see footnote k), makes the annexed Order Amending the Order Designating Countries of Origin.

Ottawa, October 10, 2014

CHRIS ALEXANDER
Minister of Citizenship and Immigration

ORDER AMENDING THE ORDER DESIGNATING COUNTRIES OF ORIGIN

1. Schedule 1 to the Order Designating Countries of Origin is amended by adding the following in alphabetical order:

  • Romania.

2. Schedule 2 to the Order is amended by adding the following in alphabetical order:

  • Andorra;
  • Liechtenstein;
  • Monaco;
  • San Marino.

COMING INTO FORCE

3. This Order comes into force on October 10, 2014.

[43-1-o]

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 17736

Ministerial Condition

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information pertaining to the substance cobalt bromide (CoBr2), Chemical Abstracts Service Registry No. 7789-43-7;

And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

LEONA AGLUKKAQ
Minister of the Environment

ANNEX

Conditions
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

“cobalt” means cobalt obtained from the transformation or dissolution of the substance, except where the expression “cobalt bromide” appears;

“effluent” means a final effluent discharged to a municipal wastewater treatment system;

“notifier” means the person who has, on June 4, 2014, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Canadian Environmental Protection Act, 1999;

“substance” means cobalt bromide (CoBr2), Chemical Abstracts Service Registry No. 7789-43-7; and

“waste” means solids that contain cobalt and are intended for disposal.

2. The notifier may import or manufacture the substance in accordance with the present ministerial conditions.

Restriction

3. The notifier may import or manufacture the substance to use it only as a catalyst in a chemical manufacturing process, or to transfer its physical possession or control to a person who will use it only in this operation.

Disposal of Waste

4. The notifier or the person to whom the substance has been transferred must deposit any waste in a secure landfill, in accordance with the laws of the jurisdiction where the landfill is located.

Environmental Release

5. The notifier shall not release more than 8 400 kg of cobalt in one or more effluents in a calendar year.

6. Where any release of cobalt to the environment occurs other than in an effluent, the person who has the physical possession or control of the substance shall immediately take all measures necessary to prevent any further release and to limit the dispersion of the substance. Furthermore, the person shall, as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Canadian Environmental Protection Act, 1999.

Record-keeping Requirements

7. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

  • (a) the use of the substance;
  • (b) the quantity of the substance that the notifier manufactures, imports, purchases, sells and uses;
  • (c) the name and address of each person to whom the notifier transfers the physical possession or control of the substance;
  • (d) the name and address of each person to whom the notifier transfers the physical possession or control of cobalt for recycling or recovery;
  • (e) the concentration of cobalt released by the notifier in an effluent, measured weekly;
  • (f) the flow rate of the effluents where cobalt is released by the notifier, measured daily; and
  • (g) the name and address of each person in Canada who has disposed of the substance or waste for the notifier, the method used to do so, and the quantities of the substance or waste shipped to that person.

(2) The notifier shall maintain electronic or paper records mentioned in subsection (1) at the notifier’s principal place of business in Canada for a period of at least five years after they are made.

Other Requirements

8. The notifier shall inform in writing any person to whom they transfer the physical possession or control of the substance, cobalt or waste, of the terms of the present ministerial conditions. The notifier shall obtain, prior to any transfer of the substance, cobalt or waste, written confirmation from this person that they were informed of the terms of the present ministerial conditions. This written confirmation shall be maintained at the notifier’s principal place of business in Canada for a period of at least five years from the day it was received.

Coming into Force

9. (1) Subject to subsection (2), these ministerial conditions come into force on September 17, 2014.

(2) Section 5 comes into force on July 1, 2016.

[43-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of 52 azo acid dyes specified on the Domestic Substances List (paragraphs 68(b) and 68(c) or subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 47 of the 52 azo acid dyes identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on certain azo acid dyes pursuant to paragraphs 68(b) and (c) or section 74 of the Canadian Environmental Protection Act, 1999 is annexed hereby;

And whereas it is proposed to conclude that the 52 azo acid dyes do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on the substances at this time.

Public comment period

Any person may, within 60 days after publication of this notice, file with the minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-938-3231 (fax), substances@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

DAVID MORIN
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

AMANDA JANE PREECE
Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the Draft Screening Assessment of Certain Azo Acid Dyes

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment on 52 azo acid dyes. These substances constitute a subgroup of the Aromatic Azo and Benzidine-based Substance Grouping being assessed as part of the Substance Groupings Initiative of the Government of Canada’s Chemicals Management Plan (CMP) based on similar chemical structures and application. Substances in this grouping were identified as priorities for action as they met categorization criteria under subsection 73(1) of CEPA 1999 and/or were considered priority substances under the CMP based on other human health concerns.

The identities of the 52 azo acid dyes are presented in the following table.

Identity of 52 azo acid dyes in the Aromatic Azo and Benzidine-based Substance Grouping

CAS RN Domestic Substances List name Colour Index name or common name
587-98-4 Benzenesulfonic acid, 3-[[4(phenylamino)phenyl]azo]-, monosodium salt Metanil Yellow
633-96-5 (see reference 1) Benzenesulfonic acid, 4-[(2-hydroxy-1-naphthalenyl)azo]-, monosodium salt Orange II
915-67-3 (see reference 2) 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-, trisodium salt Amaranth
1934-21-0 (see reference 3) 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, trisodium salt Tartrazine
2611-82-7 (see reference 4) 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[(4-sulfo-1-naphthalenyl)azo]-, trisodium salt New Coccine
3071-73-6 1-Naphthalenesulfonic acid, 8-(phenylamino)-5-[[4-[(5-sulfo-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, disodium salt Acid Black 24
3351-05-1 1-Naphthalenesulfonic acid, 8-(phenylamino)-5-[[4-[(3-sulfophenyl)azo]-1-naphthalenyl]azo]-, disodium salt Acid Blue 113
3761-53-3 2,7-Naphthalenedisulfonic acid, 4-[(2,4-dimethylphenyl)azo]-3-hydroxy-, disodium salt Ponceau MX
6262-07-3 2-Naphthalenesulfonic acid, 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulfophenyl]azo]-1-naphthalenyl]azo]-, disodium salt Acid Black 26
6507-77-3 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4-[1-[4-[(4-hydroxyphenyl)azo]phenyl]cyclohexyl]phenyl]azo]-, disodium salt Acid Orange 33
15792-43-5 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-3-[(4-dodecylphenyl)azo]-4-hydroxy-, disodium salt Acid Red 138
25317-22-0 1-Naphthalenesulfonic acid, 3-[[4-(benzoylethylamino)-2methylphenyl]azo]-4-hydroxy- Acid Red 6
29706-48-7 Benzenesulfonic acid, 3-[[[4-(2-benzothiazolylazo)-3-methylphenyl]ethylamino]methyl]- N/A
35342-16-6 7-Benzothiazolesulfonic acid, 2-[4-[(hexahydro-2,4,6-trioxo-5-pyrimidinyl)azo]phenyl]-6-methyl-, monolithium salt N/A
51988-24-0 Benzenesulfonic acid, 3-[[4-[(4-hydroxy-3-methylphenyl)azo]-3-methoxyphenyl]azo]-, monolithium salt N/A
52236-73-4 (see reference 5) Benzenesulfonic acid, 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichloro-, monolithium salt N/A
62133-79-3 2-Naphthalenesulfonic acid, 5-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]azo]-8-(phenylazo)-, disodium salt N/A
62133-80-6 2-Naphthalenesulfonic acid, 8-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]azo]-5-(phenylazo)-, disodium salt N/A
67892-55-1 1-Naphthalenesulfonic acid, 5-[[4-[(2-chlorophenyl)azo]-6(or 7)-sulfo-1-naphthalenyl]azo]-8-(phenylamino)-, disodium salt N/A
68155-63-5 2,7-Naphthalenedisulfonic acid, 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]-, disodium salt N/A
68555-86-2 Benzenesulfonic acid, 4-[[5-methoxy-4-[(4-methoxyphenyl)azo]-2-methylphenyl]azo]-, sodium salt Acid Orange 156
70210-05-8 2,7-Naphthalenedisulfonic acid, 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(4-methylphenyl)sulfonyl]amino]-, disodium salt N/A
70210-06-9 Benzenesulfonic acid, 3-[[ethyl[4-[[4-[(3-sulfophenyl)azo]-1-naphthalenyl]azo]phenyl]amino]methyl]-, disodium salt N/A
70210-25-2 2,7-Naphthalenedisulfonic acid, 5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(4-nitrophenyl)azo]-, disodium salt N/A
70210-34-3 2,7-Naphthalenedisulfonic acid, 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-, tetrasodium salt N/A
71720-89-3 2-Naphthalenesulfonic acid, 5-[[4-(4-cyclohexylphenoxy)-2-sulfophenyl]azo]-6-[(2,6-dimethylphenyl)amino]-4-hydroxy-, disodium salt N/A
71873-51-3 Benzenesulfonic acid, 2,5-dichloro-4-[4-[[5-[[(dodecyloxy)carbonyl]amino]-2-sulfophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-, disodium salt N/A
72496-92-5 Naphthalenesulfonic acid, 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]phenyl]azo]-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-, trisodium salt N/A
72828-67-2 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4-[1-[4-[(4-hydroxyphenyl)azo]phenyl]cyclohexyl]phenyl]azo]-, potassium sodium salt N/A
72828-83-2 2,7-Naphthalenedisulfonic acid, 5-(benzoylamino)-3-[[2-(2-cyclohexylphenoxy)phenyl]azo]-4-hydroxy-, disodium salt N/A
72968-80-0 2-Naphthalenesulfonic acid, 5-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo]-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-, disodium salt N/A
72968-81-1 2-Naphthalenesulfonic acid, 8-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo]-5-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-, disodium salt N/A
72986-60-8 2-Naphthalenesulfonic acid, 5-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-8-[[4-[(phenylsulfonyl)oxy]phenyl]azo]-, disodium salt N/A
72986-61-9 2-Naphthalenesulfonic acid, 8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-5-[[4-[(phenylsulfonyl)oxy]phenyl]azo]-, disodium salt N/A
75949-73-4 Benzenesulfonic acid, 4,4′-[methylenebis[4,1-phenyleneazo(4,5-dihydro-3-methyl-5-oxo-1H-pyrazole-4,1-diyl)]]bis[3-methyl-, disodium salt N/A
79234-36-9 2,7-Naphthalenedisulfonic acid, 5-(benzoylamino)-3-[[2-(4-cyclohexylphenoxy)phenyl]azo]-4-hydroxy-, disodium salt N/A
83006-48-8 Benzenesulfonic acid, 4-[4-[[3-[(ethylphenylamino)sulfonyl]-4-methylphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]- N/A
83006-74-0 1-Naphthalenesulfonic acid, 8-(phenylamino)-5-[[4-[(5-sulfo-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, ammonium sodium salt N/A
83006-77-3 1-Naphthalenesulfonic acid, 8-(phenylamino)-5-[[4-[(3-sulfophenyl)azo]-1-naphthalenyl]azo]-, ammonium sodium salt N/A
83027-51-4 1,7-Naphthalenedisulfonic acid, 6-[[2-(4-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt N/A
83027-52-5 1,7-Naphthalenedisulfonic acid, 6-[[2-(2-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt N/A
83221-60-7 1,6-Naphthalenedisulfonic acid, 4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulfo-2-naphthalenyl]azo]-1-naphthalenyl]azo]-, ammonium sodium salt N/A
84559-92-2 2,7-Naphthalenedisulfonic acid, 3,3′-[azoxybis[(2-methoxy-4,1-phenylene)azo]]bis[4,5-dihydroxy-, tetralithium salt N/A
84962-50-5 Benzenesulfonic acid, 2,5-dichloro-4-[[2-(dibutylamino)-4-methyl-6-[[2-(4-sulfophenyl)ethyl]amino]-5-pyrimidinyl]azo]-, sodium salt N/A
85030-31-5 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[[4-[[4-[(2-hydroxy-6-sulfo-1-naphthalenyl)azo]-2-methylphenyl]methyl]-3-methylphenyl]azo]-, sodium salt N/A
85136-25-0 2,7-Naphthalenedisulfonic acid, 3,3′-[azoxybis[(2-methoxy-4,1-phenylene)azo]]bis[4,5-dihydroxy-, lithium sodium salt N/A
85223-35-4 102616-51-3 (see reference a) Benzoic acid, 3,3′-methylenebis[6-[[2,4-dihydroxy-5-[(4-sulfophenyl)azo]phenyl]azo]-, sodium salt N/A
90218-20-5 (see reference b) Benzenesulfonic acid, 5-amino-2,4-dimethyl-, diazotized, coupled with diazotized 2,4-, 2,5- and 2,6-xylidine and 4-[(2,4-dihydroxyphenyl)azo]benzenesulfonic acid, sodium salts N/A
90432-08-9 (see reference c) 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 4-nitro-1,3-benzenediamine and resorcinol, potassium sodium salts N/A
90459-02-2 (see reference d) 2,7-Naphthalenedisulfonic acid, 5-amino-4-hydroxy-3-[[6-sulfo-4-[(4-sulfo-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol, potassium sodium salts N/A
106028-58-4 2,7-Naphthalenedisulfonic acid, 6-amino-4-hydroxy-3-[[7-sulfo-4-[(4-sulfophenyl)azo]-1-naphthalenyl]azo]-, tetralithium salt N/A
114910-04-2 (see reference e) 1-Naphthalenediazonium, 4-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-6-sulfo-, chloride, reaction products with formaldehyde and salicylic acid, ammonium sodium salts N/A

Abbreviations: CAS RN, Chemical Abstracts Service Registry Number; N/A, not available

  • Reference 1
    This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference 2
    This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference 3
    This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference 4
    This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference 5
    This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference a
    Two CAS RNs represent the same substance.
  • Reference b
    UVCB: unknown or variable composition, complex reaction products, or biological materials.
  • Reference c
    UVCB: unknown or variable composition, complex reaction products, or biological materials.
  • Reference d
    UVCB: unknown or variable composition, complex reaction products, or biological materials.
  • Reference e
    UVCB: unknown or variable composition, complex reaction products, or biological materials.

Azo acid dyes are not expected to occur naturally in the environment. No manufacture of any substance above the 100 kg/year reporting threshold has been reported in response to any recent surveys under section 71 of CEPA 1999. Ten substances have been reported as having an import quantity above the 100 kg/year survey reporting threshold.

Environment

All azo acid dyes are soluble in water, generally with solubility well above 1 g/L. Given the import and use of 10 azo acid dyes in Canada above reporting thresholds, potential releases to the aquatic environment have been estimated. Considering the physical and chemical properties of these substances, when released to water, it is expected that the azo acid dyes may remain in the water column for relatively long periods of time due to their hydrophilicity, but will ultimately partition to suspended solids, sediments or soil particles via electrostatic interactions. Available experimental and modelled data regarding the abiotic and biotic degradation of the azo acid dyes indicate that these substances are persistent in water, sediment and soil. In anaerobic environments (i.e. anoxic layers of sediments), there is the potential for these substances to degrade to aromatic amines as a result of cleavage of the azo bond under anaerobic or reducing conditions.

Although there are limited experimental data available, information on the log octanol–water partition coefficients and fish bioconcentration factors indicates that these substances are not likely to bioconcentrate or bioaccumulate in aquatic organisms.

While all azo acid dyes are structurally related and are expected to have a common mode of action and environmental fate profile, review of physical–chemical and ecotoxicity data allowed the dyes to be divided into subsets of monoazo, disazo and polyazo acid dyes for which aquatic toxicity levels were variable. Disazo acid dyes presented the highest levels of toxicity (effects at concentrations below 10 mg/L) while monoazo acid dyes showed lower toxicity (effects at concentrations below 100 mg/L). Polyazo substances were the least toxic to aquatic organisms (no effects below 100 mg/L). Soil toxicity data were limited, while sediment toxicity data were not available for these substances.

Risk quotient analyses were focused on exposure scenarios representing potential major environmental releases due to industrial activities involving azo acid dyes that may result in high levels of exposure of aquatic organisms. Predicted environmental concentrations were calculated for the aquatic environment for those substances identified in industrial formulation activities. Predicted environmental concentrations were not found to exceed the predicted no-effect concentrations for water.

Considering all available lines of evidence presented in this draft Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from azo acid dyes. It is proposed to conclude that the 52 azo acid dyes considered in this assessment do not meet the criteria under paragraph 64(a) or (b) of CEPA 1999, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Human health

Exposure of the general population of Canada to azo acid dyes from environmental media is considered negligible. Seventeen azo acid dyes (Acid Black 24, Acid Black 26, Acid Blue 113, Acid Orange 33, Acid Red 6, Acid Red 138, amaranth, new coccine, Orange II, tartrazine, CAS RN 68155-63-5, CAS RN 70210-05-8, CAS RN 70210-06-9, CAS RN 70210-25-2, CAS RN 70210-34-3, CAS RN 71873-51-3 and CAS RN 84962-50-5) were indicated to be present in products in the Canadian marketplace that may lead to exposure of the general population to these substances. Exposure to amaranth and tartrazine occurs predominantly through food intake and use of cosmetics, as well as through use of personal care drugs for tartrazine. Exposure to new coccine and Orange II is predominantly through use of cosmetics. Exposure to the other 13 azo acid dyes is through contact with textile and/or leather products.

Margins between the upper-bounding estimates of oral exposure to amaranth from food and cosmetics and the critical health effect level from a chronic dietary study in rats are considered adequate to address uncertainties in the exposure and health effects databases.

Margins between the upper-bounding estimates of exposure to new coccine in certain cosmetics and the critical health effect levels are considered adequate to address uncertainties in the exposure and health effects databases.

Margins between the upper-bounding estimates of oral exposure to Orange II in lipstick and the critical health effect levels determined in oral studies in laboratory animals are considered adequate to address uncertainties in the exposure and health effects databases. Similarly, margins between the upper-bounding estimates of dermal exposure to Orange II in certain cosmetics and the no-observed-effect level from the dermal study in mice are considered adequate to address uncertainties in the exposure and health effects databases.

Margins between the upper-bounding estimates of exposure to tartrazine in food, cosmetics and personal care drugs and the critical health effect levels are considered adequate to address uncertainties in the exposure and health effects databases.

A range of critical effect levels from oral repeated-dose studies on azo acid dyes in this subgroup and relevant analogues was identified. However, no effects were observed in a chronic study in which mice received weekly applications to the skin of several azo acid dyes in this subgroup. These data were the basis for the risk characterization of 10 azo acid dyes lacking empirical data (Acid Red 138, CAS RN 71873-51-3, CAS RN 84962-50-5, Acid Orange 33, Acid Red 6, Acid Black 26, CAS RN 70210-05-8, Acid Blue 113, Acid Black 24 and CAS RN 70210-06-9). Margins between upper-bounding estimates of oral exposure via mouthing of textile objects by infants and the range of oral critical effect levels were considered adequate to address uncertainties in the exposure and health effects databases. Margins between upper-bounding estimates of dermal exposure from direct and prolonged contact with textiles containing these dyes and the noobserved-effect level from the dermal study were considered adequate to address uncertainties in the exposure and health effects databases.

For three azo acid dyes (CAS RN 68155-63-5, CAS RN 70210-25-2 and CAS RN 70210-34-3), potential exposure of the general population via leather products was identified. As exposure to leather products is considered short term and intermittent and as available information does not indicate that azo acid dyes demonstrate high acute toxicity, the risk to human health for the general population is expected to be low.

For the remaining 35 azo acid dyes, available information did not identify the potential for direct and prolonged exposure of the general population. Accordingly, the risk for the general population from exposure to these substances is expected to be low.

Two of the substances in this assessment, Ponceau MX (CAS RN 3761-53-3) and the substance bearing CAS RN 75949-73-4 (no common name), are considered to have human health effects of concern based on potential carcinogenicity. However, for the general population of Canada, exposure to these substances is not currently expected.

On the basis of the available data, it is proposed to conclude that the 52 azo acid dyes evaluated in this assessment do not meet the criteria under paragraph 64(c) of CEPA 1999 as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall proposed conclusion

It is proposed to conclude that the 52 azo acid dyes evaluated in this assessment do not meet any of the criteria set out in section 64 of CEPA 1999.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances in this assessment are recognized to have human health effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposure of the general population of Canada to these substances were to increase through products available to consumers such as textiles, cosmetics, food, drugs and natural health products.

Options on how best to monitor changes in the use profile of these substances are being investigated. Stakeholders will have the opportunity to provide feedback on a consultation document, describing potential options for information gathering or preventive actions, to be published once assessments for all of the Aromatic Azo and Benzidine-based Substance Grouping are completed.

Although it is not proposed that amaranth is harmful to human health at current levels of exposure, the Government of Canada will be working to update existing food additive provisions for amaranth in the List of Permitted Colouring Agents, which applies to foods sold in Canada. The updates will better align the food additive provisions with current uses and ensure that intakes of amaranth remain within acceptable levels.

The draft Screening Assessment is available on the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca).

[43-1-o]

DEPARTMENT OF INDUSTRY

RADIOCOMMUNICATION ACT

Notice No. SMSE-016-14 — Release of new issue of RSS-199

Notice is hereby given by Industry Canada that the following document will come into force immediately:

  • Radio Standards Specification RSS-199, Issue 2: Broadband Radio Service (BRS) Equipment Operating in the Band 2500-2690 MHz, which sets out the certification requirements for BRS radio transmitters and receivers in the band 25002690 MHz.

The above-mentioned document was published to reflect recent changes in Industry Canada policy on BRS and on equipment and certification requirements.

General information

This document has been coordinated with industry through the Radio Advisory Board of Canada (RABC).

The Radio Technical Standards List will be amended to reflect the above-mentioned changes.

Submitting comments

Interested parties are requested to provide their comments within 120 days of the date of publication of this notice in electronic format (Microsoft Word or Adobe PDF) to the Manager, Radio Equipment Standards (res.nmr@ic.gc.ca).

Written submissions should be addressed to the Director General, Engineering, Planning and Standards Branch, Industry Canada, 19th Floor, 300 Slater Street, Ottawa, Ontario K1A 0C8.

All submissions received by the close of the comment period will be posted on Industry Canada’s Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on Industry Canada’s Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at www.gazette.gc.ca/rp-pr/p1/index-eng.html.

October 3, 2014

DANIEL DUGUAY
Acting Director General
Engineering, Planning and Standards Branch

[43-1-o]