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加拿大修订国内物质清单里氏木霉ATCC 74252相关内容

放大字体  缩小字体 发布日期:2018-02-27  来源:加拿大环境与气候变化部  浏览次数:172
核心提示:加拿大修订国内物质清单里氏木霉ATCC 74252相关内容。
【发布单位】 加拿大环境与气候变化部
【发布文号】 Vol. 152, No. 8
【发布日期】 2018-02-24
【生效日期】 2018-02-24
【废止日期】
【替代法规】
【效  力】
【食品伙伴网解读】 加拿大修订国内物质清单,删除清单第五部分里氏木霉ATCC 74252相关内容,并在第六部分新增里氏木霉ATCC 74252 S′活性功能。
 GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to amend the Domestic Substances List under subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to the living organism Trichoderma reesei ATCC 74252

Whereas the living organism Trichoderma reesei ATCC 74252 is specified on the Domestic Substances List; (see footnote 1)

Whereas the Minister of the Environment and the Minister of Health (the ministers) have conducted a screening assessment of the living organism under section 74 of the Canadian Environmental Protection Act, 1999; (see footnote 2)

And whereas the ministers suspect that the information concerning a significant new activity in relation to the living organism may contribute to determining the circumstances in which the living organism is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,

Therefore, notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to any significant new activities relating to the living organism, as set out in this notice.

Public comment period

Any person may, within 60 days of the publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec, K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.

The final screening assessment for this living organism may be obtained from the Canada.ca (Chemical Substances) website.

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.

George Enei
Assistant Deputy Minister
Science and Technology Branch

On behalf of the Minister of the Environment

ANNEX

1. Part 5 of the Domestic Substances List is proposed to be amended by deleting the following under the heading “Organisms/Organismes”:

Trichoderma reesei ATCC 74252

2. Part 6 of the List is proposed to be amended by adding the following in alphabetical order:

Column 1

Living organism

Column 2

Significant new activity for which living organism is subject to subsection 106(3) of the Act

Trichoderma reesei ATCC 74252 S′

1. Any activity involving the living organism in Column 1, opposite to this section, other than

· (a) its submerged fermentation in the absence of light with no solid plant material or insoluble substrate present;

· (b) its use as a research and development organism, as this expression is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms); or

· (c) its culture in a vessel where it is inactivated prior to or upon removal from the vessel and all solid and liquid wastes from the living organism are incinerated.

 

2. For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the commencement of the proposed significant new activity:

· (a) a description of the proposed significant new activity in relation to the living organism;

· (b) the information specified in paragraphs 1(a) to (g), sections 2 and 3, paragraphs 4(a) and (c), and sections 7 and 9 of Schedule 1 to the New Substances Notification Regulations (Organisms);

· (c) the data and report from a study conducted to determine the identity and quantity of peptaibols produced by the living organism and present in any liquid culture medium in the course of the significant new activity;

· (d) if the study in paragraph (c) shows that peptaibols are produced by the living organism or present in liquid culture medium:

(i) the data and report from a study conducted to determine the effects of the living organism, in conditions where it produces peptaibols, on aquatic and terrestrial invertebrate species likely to be exposed to it in the course of the significant new activity; and

(ii) the data and report from a study conducted to determine the effects of peptaibols produced by the living organism on aquatic and terrestrial invertebrate species likely to be exposed to them in the course of the significant new activity;

· (e) all other information and test data in respect of the living organism and its secondary metabolites that are in the possession of the person proposing the significant new activity, or to which they may be reasonably expected to have access, and that are relevant to identifying the hazards of the living organism and its secondary metabolites to the environment and human health and the degree of environmental and public exposure to the living organism and its secondary metabolites;

· (f) the identification of every government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the living organism and, if known, the agency’s file number, the outcome of the assessment, and the risk management actions in relation to the living organism imposed by those agencies;

· (g) the name, civic and postal addresses and telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf;

· (h) the name, civic and postal addresses and telephone number and, if any, fax number and email address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and

· (i) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.

 

3. The studies described in paragraph 2(c) and subparagraph 2(d)(ii) must be conducted in conformity with the practices described in the OECD Principles of Good Laboratory Practice set out in Annex 2 of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, and that are current at the time the studies are conducted.

 

4. The studies described in
subparagraph 2(d)(i) must be conducted according to the Environment and Climate Change Canada report EPS 1/RM/44 titled Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms.

 

5. The above-mentioned information will be assessed within 120 days after the day on which it is received by the Minister.

Coming into Force

3. The Order would come into force on the day on which it is registered.

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