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Technical Regulation amending Annex II of the SDA/SDC N° 02, 12 July 2013, which establishes the reference specifications for plant protection products approved for organic agriculture

Draft Resolution nº 534 of 12 June 2018

Article 1 To approve the regulation that establishes the maximum limits of the relevant impurities to be investigated in the studies of five batch and controlled after registration, and gives other measures.

Article 2 This Normative Instruction applies to applicants and holders of registration of technical products, premixtures and formulated products.
§1 Technical products under registration must demonstrate compliance with the maximum limits established in the Annex of this Normative Instruction.
§2 The holders of registration of technical products, premixtures or formulated products must guarantee the maximum limits of relevant impurities stipulated in the Annex of this Normative Instruction.

Article 3 For the purpose of this Normative Instruction, any impurities that, in comparison to the active ingredient, may produce a significant toxic adverse effect on health or the environment are considered relevant impurity.
§ 1 An impurity that occurs in two different active ingredients may be considered as relevant to one and non-relevant to the other, or have different acceptable maximum limits for different active ingredients.
§2 The effects of acute oral toxicity , skin or ocular corrosion / irritation, skin sensitization, mutagenicity, carcinogenicity, reproductive toxicity or other toxicological or ecotoxicologically significant effects are considered to be toxic adverse effects of the relevant impurities.
§ 3 Impurities of toxicological or ecotoxicological concern are those impurities structurally similar to the substances or classes of substances listed in the Annex, requiring a technical evaluation, based on additional data, to consider them as relevant impurities.

Article 4 The holders of registration of technical products produced in the country or imported and of premixes and formulated products imported, based on active ingredients listed in the Annex, shall guarantee:
I - that the sampling is carried out lot by lot and is statistically representative of the quantities produced or imported, not being accepted the sampling methodology composed of more than one batch or batch; and
II - that the analyzes for the control of the relevant impurities are conducted with traceability and making use of appropriate parameters and methods.
Single paragraph. The collection and sampling methodologies will be subject to specific regulation.

Article 5 The analyzes for the control of the relevant impurities must be carried out with the technical product.
Paragraph 1 By means of justified justification, the analyzes may be carried out in the premix or in the formulated product, when imported or when it is an integrated production, and the results must be expressed according to the quantity of technical product.
Paragraph 2 When the analyzes are carried out outside the quality control unit of the manufacturer of the product, they must be carried out by an accredited laboratory in the ABNT NBR / IEC 17025, ISO 17025 or in Good Laboratory Practices - GLP, by the National Institute of Metrology, Quality and Technology - INMETRO, with valid certificate, considering the tests carried out.

Article 6 Certificates of analysis shall contain the following items:
I - batch or batch identification, date of manufacture, validity;
II - name and address of the manufacturer;
III - content of active ingredient and the relevant impurity (s), with their respective limits established in the Annex of this Normative Instruction;
IV - identification of the analytical method (s) used, with their respective quantification limits, for both active ingredient and impurity (s);
V- name and address of the laboratory where the analyzes were carried out;
VI - dates of receipt of the sample by the laboratory and date of the analysis and
VII - names, functions and signatures of the persons responsible for issuing the certificate.
Single paragraph. All analysis certificate information shall be readily identifiable and traceable, including data imputed directly to computer systems.

Article 7 The certificates of analysis must be kept vernacular under the custody of the holders of registration of the products.
Paragraph 1 When requested, registrants must present the raw data of the analyzes.
Paragraph 2 Certificates of analysis and their raw data must be finalized and available for inspection within 30 (thirty) days of the date of production in the country or importation (clearance), remaining under the custody and control of the holders of the registration for the minimum period of five (5) years.

Article 8 The registration holder shall maintain control over the destination of each lot or batch of the technical product or formulated, produced or imported, including the identification of the companies for which the product has been supplied, and this data shall remain at the disposal of the authorities for a period of at least five (5) years, counted from the date of local manufacture or importation (clearance).

Article 9 It is the responsibility of the owner of the registration to guarantee the quality of the control of impurities in the product, even when the manufacture, production, manipulation or importation of the product is performed by third parties.
Paragraph 1 The batch or batch of technical product, premix or formulated product based on active ingredient listed in the Annex to this INC may only be used or marketed after confirmation that the relevant impurity is within the limit established in this standard.
Paragraph 2 If the results of the analyzes of the imported lots indicate any relevant impurity above the maximum permitted limit, it is the responsibility of the registration holder to proceed with the appropriate measures for the return of the product.
Paragraph 3 In case the results of the analyzes of the batches produced in the country indicate any relevant impurity above the maximum permitted limit, the holder of the registration must:
I - promote preliminary investigation, including the evaluation of the need for the application of precautionary measures and corrective actions;
II - adopt measures, according to its own procedure, for the treatment of non-compliance or disposal, as the case may be; and
III - to keep all the documents related to the procedure used, for a period of five years, from the date of execution of the procedure.

Article 10 The Annex of this Normative Instruction will be updated whenever other impurities relevant to the establishment of their respective maximum limits are identified.
Paragraph 1 Relevant impurities identified in products based on new active ingredients shall have their maximum limits defined in the registration process until their forecast is expressed in an update of the Annex of this Normative Instruction.
Paragraph 2 In the case of identification of new impurities relevant to products based on active ingredients already registered, these should be controlled according to the maximum limit already established by recognized national or international organisms, until updating of the Annex of this Normative Instruction.

Article 11 Non-compliance with the provisions contained in this Normative Instruction constitutes an infraction, without prejudice to the applicable civil, administrative and penal liabilities.

Article 12 This Normative Instruction shall enter into force within thirty (30) days after the date of its publication and revokes Normative Instructions No. 2 of 20 June 2008 and No. 2 of 15 August 2014.

Ordinance No. 162, 21 June, 2018

The notified regulation opens a 60-day period for public consultation on the draft normative instruction which amended the Technical Regulation for Organic Production Systems, as well as the lists of substances and practices permitted for use in organic production.

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Proposed Prohibition of Asbestos and Asbestos Products Regulations; and Regulations Repealing the Asbestos Products Regulations

The proposed Regulations would prohibit the import, sale and use of asbestos, and the manufacture, import, sale and use of products containing asbestos with a limited number of exclusions. In addition, the proposed Regulations would not prohibit the use and sale of asbestos and products containing asbestos that were installed prior to the coming into force of the proposed Regulations (such as asbestos and products containing asbestos installed in buildings, civil engineering works, vehicles, ships, and airplanes).

The proposed Regulations would also include the following exemptions:
1) a time-limited exclusion for the import and use of asbestos in the chlor-alkali industry, until 31 December 2025;
2) an on-going exclusion for the import, sale and use of asbestos and products containing asbestos for the purpose of display in a museum; and,
3) an on-going exclusion for the import, sale and use of asbestos and products containing asbestos for scientific research, for sample characterization or as an analytical standard in a laboratory.

The proposed Regulations include labelling requirements for any asbestos imported for diaphragms in chlor-alkali facilities during the phase-out period.

The proposed Regulations would include permit provisions for unforeseen circumstances where asbestos or a product containing asbestos is used to protect human health or the environment , where there is no technically or economically feasible alternative. The permit would be valid for one year and the permit holder would be subject to reporting requirements.

Furthermore, a permit holder, museum, laboratory, or chlor-alkali facility benefitting from exclusion would need to prepare and implement an asbestos management plan.

Proposed Regulations Amending the Concentration of Phosphorus in Certain Cleaning Products Regulations

The Concentration of Phosphorus in Certain Cleaning Products Regulations limit the amount of phosphorus in laundry detergents, household dish-washing compounds and certain household cleaners that are manufactured or imported into Canada.

The proposed Amendments will exempt goods in transit through Canada to ensure Canada’s consistency with the World Trade Organization's (WTO) Agreement on Trade Facilitation (the Agreement). In addition, they would clarify that the concentration limit for phosphorus in household clean ing products does not apply to products used exclusively as metal cleaners or de-greasing compounds (the limits would still apply to household multifunctional cleaners); and standardize laboratory accreditation provisions with other regulations under the purview of Environment and Climate Change Canada (ECCC).

Proposed Regulations Amending the Contaminated Fuel Regulations

The Contaminated Fuel Regulations ("the Regulations") prohibit the import and export of fuels mixed with toxic substances, with exemptions to imports for the purpose of destruction, disposal and recycling. The import and export of contaminated fuels have been prohibited in Canada since 1991 under the Regulations.

The proposed amendments would exempt contaminated fuels in transit from the prohibition on imports and exports of contaminated fuels. The proposed amendments would add subsection (3) to section 4 of the Regulations stating that “A person does not contravene section 3 if the contaminated fuel is in transit through Canada, from a place outside Canada to another place outside Canada, and there is written evidence establishing that the fuel is in transit.”