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Top International News in Chemical Policy and Regulation- January 27, 2017: Americas

CANADA

Canada Publishes Technical Guidance On HPA And HPR Requirements: In December 2016, Health Canada published Technical Guidance on the Requirements of the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR) -- WHMIS 2015 Supplier Requirements. Health Canada states that the purpose of the document is to provide guidance on the requirements of HPA and HPR to suppliers of hazardous products destined for Canadian workplaces. The document also provides suppliers with information on the Hazardous Materials Information Review Act (HMIRA) and its regulations and the mechanism to protect confidential business information (CBI).

PMRA Reviews Data Protection Program For Pesticides: The Pest Management Regulatory Agency (PMRA) has released for comment a proposed Agreement for Data Protection under Section 66 of the Pest Control Products Act (currently called the Ministerial Agreement for Data Protection under the Pest Control Products Act) and the proposed Eligibility Criteria for Compensable Protection Status for Foreign Test Data. PMRA previously requested advice from a neutral third party consultant on whether its pesticide data protection system achieves the right balance between encouraging the registration of new innovative products and generic pesticides. In November 2014, PMRA received the final report and sent it to stakeholders. According to PMRA, the report indicated that most stakeholder representatives from among grower groups, innovative companies, and generics companies supported the overall approach and design of the data protection program, and saw no need for a fundamental re-design. At the same time, PMRA states, many stakeholders noted that the current design and delivery of a number of key process elements were limiting the timeliness and predictability of the data protection program, and inhibiting the rate at which companies were seeking to register generic products. PMRA addressed many of the recommendations regarding the application process, including timeliness, through the revised process set out in the Memorandum to Applicants and Registrants: Data Protection Submission Review Process. PMRA states that the proposed documents for the consultation are intended to address the recommendations for changes to the arbitration process and to clarify foreign test data eligibility criteria. Comments are due February 13, 2017.

Canada Begins DSL Inventory Update: On January 17, 2017, Environment and Climate Change Canada published a notice in the Canada Gazette with respect to substances included as part of the 2017 Domestic Substances List (DSL) Inventory update. Persons required to provide information include:

 

Any person who, during the 2014 or 2015 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance listed in Part 1, Part 2, or Part 3 of Schedule 1 to this notice;

 

Any person who, during the 2014 or 2015 calendar year, manufactured a total quantity greater than 100 kg of a substance listed in Part 4 of Schedule 1 to this notice that is a cosmetic, food, therapeutic product or natural health product subject to the Food and Drugs Act or is intended to be a component in such products;

 

Any person who, during the 2014 or 2015 calendar year, imported a total quantity greater than 100 kg of a substance listed in Part 1, Part 2, or Part 3 of Schedule 1 to this notice, whether the substance is:

a.

Alone;

b.
 

At a concentration equal to or above 0.1 percent by weight (w/w%) in a mixture or in a product; or

c.

 

Listed in Part 3 of Schedule 1 and at a concentration equal to or above 0.1 percent by weight (w/w%) in a manufactured item that is:

i.

Intended to be used by or for children under the age of six years;

ii.
 

Intended to come into contact with the mucosa of an individual, other than eyes;

iii.

 

Cookware, or a cooking or serving utensil that is intended to come into direct contact with heated food within a residence, unless the component that comes into direct contact with heated food is made of glass, stainless steel, or porcelain;

iv.

 

Food packaging that is intended to come into direct contact with food, unless the component that comes into direct contact with food is made of glass, stainless steel, or porcelain;

v.

 

A reusable food or beverage container, unless the component that comes into direct contact with food or beverage is made of glass, stainless steel or porcelain;

vi.

 

Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual;

vii.

Clothing or footwear,

viii.

Bedding, a sleeping bag, or a towel,

ix.

 

Furniture, a mattress, a cushion, or a pillow intended to be used in a residence, where the substance is contained in foam or leather or in a textile fiber, yarn, or fabric, or

x.

Carpet, vinyl, or laminate flooring, or foam underlay for flooring, intended to be used in a residence.

 

Any person who, during the 2014 or 2015 calendar year, imported a total quantity greater than 100 kg of a substance, listed in Part 4 of Schedule 1 to this notice, that is, is contained in, or is intended to be a component in, a cosmetic, food, therapeutic product or natural health product subject to the Food and Drugs Act; and

 

Any person for whom the criteria set out in Schedule 2 have been met for both the 2014 and 2015 calendar years shall provide information prescribed in Sections 6 to 10 of Schedule 3 to this notice for the 2015 calendar year only.

The notice does not apply to a substance listed in Schedule 1, whether alone, in a mixture, in a product, or in a manufactured item, that:

Is in transit through Canada;


 

Is tin fluoride (Chemical Abstracts Service (CAS) Number 7783-47-3) contained in dental care products or mixtures;

 

Is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and was imported pursuant to a permit issued under these Regulations;


 

Is, or is contained in, a pest control product registered under the Pest Control Products Act;


 

Is, or is contained in, a fertilizer or supplement registered under the Fertilizers Act;

Is, or is contained in, a feed registered under the Feeds Act; or

Is mixed with, or attached to, a seed registered under the Seeds Act.

If a person provided information under the New Substances Notification Regulations for a substance listed in Part 4 of Schedule 1, a response from that person is not required for that substance. Responses are due July 17, 2017, no later than 3:00 p.m. EDT.

COLOMBIA

Colombia Publishes Draft Regulation Adopting GHS: The Colombian Ministry of Labor and Social Security has published a Draft Decree that proposes to implement the GHS in the country. The Draft Decree will incorporate the 6th Edition of the United Nations (UN) GHS (“Purple Book”), and would require that when future iterations of the GHS regulation are published, multiple Ministries (Transport, Commerce, Agriculture, Labor and Health) would have six months to review the revised System and incorporate any changes into National law. The Draft Decree is perhaps predictably comprehensive in its scope, following in the footsteps of several other South American countries (e.g., Argentina, Brazil) that have implemented the System in recent years. As proposed, there are no exemptions for either public or private entities, and the Draft Decree does not distinguish between hazardous and non-hazardous substances (pure form, mixtures, or solutions). Any entity that produces, imports, stores, distributes and/or sell chemical substances must evaluate their substances and classify them accordingly. There is presently no defined adoption date for the final Decree.

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