Administrative Arrangement (AA) between the Department of Health of Canada and the European Commission's Directorate-General for Justice and Consumers on the exchange of information on the safety of non-food consumer products

This Administrative Arrangement (AA) is concluded between the Department of Health of Canada (Health Canada) and the Directorate-General for Justice and Consumers of the European Commission (DG Justice and Consumers), hereinafter referred to as the “Participants”.

DG Justice and Consumers is the European Commission’s Department responsible for the European Union (EU) policies and legislation in the areas of consumer protection and the General Product Safety Directive 2001/95/EC, for operating the Rapid Alert System on non-food products (RAPEX), and for promoting and organising administrative cooperation between the enforcement authorities of the EU Member States and European Economic Area countries for the objectives of these acts.

Regulation (EC) 765/2008, setting out the requirements for accreditation and market surveillance relating to the marketing of products, provides that the Rapid Alert System on non-food products (RAPEX) provided for in Directive 2001/95/EC is also used for information exchange between the EU Member States on dangerous harmonised products requiring rapid intervention, including cosmetics. Harmonised products are substances, preparations or goods produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction which fall within the scope of specific Union harmonisation legislation, whether intended for consumers or for professional users.

The Consumer Product Safety Directorate (CPSD) is Health Canada’s directorate responsible for identifying, assessing, managing and communicating to Canadians any health or safety risks associated with consumer products under the Canada Consumer Product Safety Act and related regulations, and cosmetics under the Food and Drugs Act and the Cosmetic Regulations and is responsible for operating the Regulatory Action Depot / Dépôt d’Actions Réglementaires (RADAR) case management system. Health Canada designates the CPSD to implement this Administrative Arrangement.

Both Participants aim to protect the health and safety of consumers in their respective jurisdictions to the highest possible degree.

Global product supply chains result in the EU and Canadian authorities often facing similar consumer product safety challenges, as the same products or types of products may appear in their respective jurisdictions, even when produced in third countries.

This voluntary mechanism for the sharing and exchange of information is based on Article 21.7 of the Comprehensive Economic and Trade Agreement (CETA), concluded between the EU and its Member States and Canada in Brussels on 30 October 2016.

Chapter XXI of the CETA on Regulatory Cooperation provides that the Parties endeavour to cooperate and share information on a voluntary basis in the area of non-food product safety.

Article 21.7 (4) of Chapter XXI of the CETA provides that the Parties may establish reciprocal exchange of information on the safety of consumer products and on preventive, restrictive and corrective measures taken. In particular, Canada may receive access to selected information from the EU's RAPEX alert system, or its successor, with respect to consumer products, as referred to in Directive 2001/95/EC on general product safety, and the EU may receive early warning information on restrictive measures and product recalls from Canada's consumer product incident reporting system, known as RADAR, or its successor, with respect to consumer products, as defined in the Canada Consumer Product Safety Act, S.C. 2010, c. 21, and cosmetics, as defined in the Food and Drugs Act, R.S.C. 1985, c. F-27.

Paragraphs 5, 6 and 7 of Article 21.7 of Chapter XXI of the CETA further provide the conditions under which the Parties intend to implement the voluntary mechanism for the exchange of information between them.

This AA is limited to those products which are:

• either harmonised at EU level or fall under Directive 2001/95/EC, and
• at the same time regulated by Health Canada under “consumer products and cosmetics”.

Those products are defined in this AA as “consumer products”.

Directive 2001/95/EC provides for the possibility to give access to RAPEX to third countries, within the framework of agreements between the EU (formerly Community) and those countries, according to arrangements which are based on reciprocity and include provisions on confidentiality corresponding to those applicable in the EU (formerly Community).

The voluntary mechanism for the sharing and exchange of information related to the management of consumer product safety is not intended to contain personal data or personal information.

Both Participants are required to comply with the laws, regulations and policies applicable within their respective jurisdictions related to the protection of personal information and personal data. In particular, Health Canada is required to comply with the Privacy Act, the Access to Information Act and the Canada Consumer Product Safety Act and DG Justice and Consumers is required to comply with Regulation (EC) 45/2001 on data processing by Community institutions and bodies.

Both Participants will act in accordance with the laws, regulations and policies applicable within their respective jurisdictions regarding the collection, treatment, transmission, storage, protection, maintenance and disposition of information shared under this AA.

1. Objective and Purpose

• The Objective of this AA is to facilitate cooperation and information sharing between the Participants on the safety of consumer products and on preventive, restrictive and corrective measures taken.
• The Participants understand that the sole purpose of the exchange of information under this AA is to allow each Participant to gain access to information about dangerous consumer products posing a risk to the health or safety of consumers in their respective jurisdictions, and to take any necessary action to protect consumers in each jurisdiction from such risks within the shortest possible timeframe.
• The Participants intend not to use or disclose information shared under this AA for any purpose other than that envisaged by this AA.
• The Participants intend to make all reasonable efforts to ensure that any information shared pursuant to this AA is accurate and up-to-date. Where one of the Participants becomes aware that the information it has transferred or received is inaccurate, it intends to inform the other Participant without undue delay. The Participants intend to make all reasonable efforts to ensure that inaccurate information is rectified without undue delay.

2. Definitions

For the purpose of this AA:

Confidential information means all information deemed confidential under the respective laws of the Participants. It includes, but is not limited to, "confidential business information" as defined in section 2 of the Canada Consumer Product Safety Act and “trade secret” as defined in Article 2 of the Directive on the protection of undisclosed know-how and business information ((EU)2016/943);

Consumer products mean products that are defined both as products under the EU Directive 2001/95 and as consumer products or cosmetics under the Canada Consumer Product Safety Act and the Food and Drugs Act respectively;

Data fields mean the fields in RAPEX or RADAR respectively and on which both Participants intend to exchange information, provided that this information is available. A list of data fields covered by this AA is given in Annex II;

Incident report means a report made to Health Canada about an incident, as defined under section 14 of the Canada Consumer Product Safety Act;

Legal person means a person who is not a natural person within the meaning of Article 2 of Regulation (EC) No 45/2001 or who cannot identify a natural person;

Natural person means an identified or identifiable natural person as defined in Article 2 of Regulation (EC) No 45/2001;

Non-publicly available information means any information exchanged between the Participants that is not available to the public and does not include “Confidential information” as defined in this AA;

Personal data/Personal information means “personal data” as defined in Article 2 a) of Regulation (EC) No 45/2001; “personal information” as defined in section 3 of the Privacy Act, R.S.C., 1985, c. P-21;

RAPEX means the Community Rapid Information System, established under Article 12 of Directive 2001/95/EC;

RAPEX notification means the information provided by EU Member States on the measures or actions, either adopted by them or which they have recommended to or agreed with economic operators, to prevent, restrict or impose specific conditions on the possible marketing or use, within their own territory, of dangerous products;

RADAR means the Regulatory Action Depot / Dépôt d’Actions Réglementaires, which is Health Canada's case management system for consumer products;

RADAR case means the reference number from the Health Canada database identifying specific incident reports, as well as other activities, for which a technical assessment report may be prepared and/or a recall may take place;

Risk Assessment means the assessment of whether a product poses a risk to health or safety and the seriousness of such a risk;

Test report means a document listing the testing completed to verify the compliance status of specific product(s) and its results.

3. Scope

The Participants intend to exchange information covering the consumer product categories as listed in Annex I.

The Participants intend to exchange information on consumer products which pose or may pose a risk to human health or safety.

4. Type of information exchanged

• The Participants intend to exchange information on the data fields as listed in Annex II.
• Both Participants understand that the information exchanged may not always include values for all the data fields as listed in Annex II, in case it is not available.
• DG Justice and Consumers intends to give Health Canada access to selected information from RAPEX, or its successor, with respect to consumer products as defined in this AA and listed in Annex I, assuming that the notifying Member State has not specifically requested the information not to be shared with a third country.
• Health Canada intends to give DG Justice and Consumers access to selected information from RADAR, or its successor, with respect to consumer products as defined in the Canada Consumer Product Safety Act and cosmetics as defined in the Food and Drugs Act and listed in Annex I. The information will consist of RADAR cases regarding product recalls, advisories, safety alerts, industry incident reports, risk assessments and test reports. Moreover, Health Canada intends to provide consumer product early risk warning information to DG Justice and Consumers - when possible, before this information becomes publicly available.

5. Modalities for the exchange of information

(a) Modalities concerning information provision by DG Justice and Consumers to Health Canada

(i) Technical means

DG Justice and Consumers intends to provide Health Canada with the information via a suitably secured/encrypted user interface which provides a download option in MSExcel format. This interface will have a secured URL and will only be accessed by authorised users. There will be a maximum of 10 authorised user accounts provided to Health Canada at any one time.

(ii) Automatic flagging of information of interest

RAPEX notifications concerning products whose country of origin or country of destination is Canada will be automatically flagged by a special icon and text. Updates and deletions of RAPEX notifications made by DG Justice and Consumers will also be automatically flagged.

(iii) Timeframe

DG Justice and Consumers intends to make available to Health Canada new RAPEX notifications validated by DG Justice and Consumers, as well as updates of previous notifications as soon as practicable and on a jointly decided upon daily schedule.

(iv) Two-tier system:

The Participants understand that test reports and detailed risk assessments pertaining to the products in RAPEX which pose a risk to the health or safety of consumers are attachments submitted by the EU Member States along with the RAPEX notifications and they may be in any EU language. As these attachments may contain personal data, they will not be automatically provided to Health Canada.

A summary of the test reports and risk assessments will be contained in the subset of RAPEX notifications provided to Health Canada.

When a specific issue warrants more information, Health Canada may request DG Justice and Consumers to provide complete test reports and/or detailed risk assessments for specific notifications. If such documents are available, DG Justice and Consumers intends to send to Health Canada a version in which personal data has been removed.

(b) Modalities concerning information provision by Health Canada to DG Justice and Consumers

(i) Technical means

Health Canada intends to provide DG Justice and Consumers with structured, machine-readable and automatically retrievable data via a suitably secured/encrypted mechanism. The data will consist of RADAR cases related to product recalls, advisories, safety alerts, industry incident reports, risk assessments and test reports.

The data provided by Health Canada to DG Justice and Consumers may not necessarily be validated by Health Canada, which means that it might include records for which no corrective measures or regulatory actions are deemed necessary or initiated, whatever the reason.

(ii) Timeframe

Health Canada intends to make available fully updated records as soon as practicable and on a jointly decided upon daily schedule.

(iii) Sharing of Early Information

Moreover, Health Canada intends to share early information with DG Justice and Consumers on corrective measures and product recalls - when possible, before the information becomes publicly available. When practicable, case records resulting in product recalls and other corrective measures may be shared as early as the calendar day after the measures are initiated.

6. Storage, retention, protection and disposal of information received

• The Participants intend to store, protect and dispose of the information received from the other Participant in compliance with, and for the necessary period of time consistent with, the laws, regulations and policies applicable to their respective jurisdiction.
• Health Canada intends to retain the information received from DG Justice and Consumers for no longer than is necessary for the purpose for which the information has been provided, unless this is required by the laws, regulations and policies applicable to its jurisdiction.
• DG Justice and Consumers intends to retain the information received from Health Canada for no longer than is necessary for the purpose for which the information has been provided, unless this is specifically required by laws and regulations that impose longer retention periods for important objectives of public interest in a proportionate manner.
• Participants intend to have in place appropriate technical and organisational measures to protect the information they receive against unauthorised or unlawful processing and against accidental loss, destruction or damage.
• Health Canada will comply with the Access to Information Act and the Library and Archives of Canada Act.
• DG Justice and Consumers will comply with Regulation (EC) 1049/2001 on public access to EU institution documents and Regulation (EC) 45/2001 on data processing by Community institutions and bodies.

7. Personal Data / Personal information

• The current AA is not intended to contain data and information that is personal and the Participants intend to make all reasonable efforts to ensure that personal data and personal information is not shared or exchanged with each other.
• If one Participant discovers that personal data or personal information has been provided or received inadvertently, the Participant intends to immediately inform the other Participant. The recipient Participant intends to take immediate and appropriate measures to permanently destroy the record(s) containing personal data or personal information and the providing Participant intends to provide an updated record with personal data and/or personal information removed.
• In case information on legal persons identifies a natural person, both Participants intend to consider such information as personal data and/or personal information and treat it according to 7 (a) and 7 (b) above.

8. Confidentiality and treatment of non-publicly available information

• The Participants intend to consider all the confidential and/or non-publicly available information shared by the other Participant under this AA as to be protected, i.e. not to be published or actively shared outside of the purpose of this agreement, in accordance with paragraphs 8 (b) to 8 (h).
• The Participants intend to protect confidential and/or non-publicly available information shared by the other Participant under this AA in accordance with the laws, regulations and policies applicable to their respective jurisdiction.
• The Participants understand that confidential and/or non-publicly available information will be provided for the purpose of carrying out functions concerning the protection of human health or safety in relation to consumer products and intend to use it only for that purpose.
• The Participant receiving confidential and/or non-publicly available information may disclose it to its employees, contractors or agents who:
  • require the information solely for advancing the purpose of this AA;
  • will only use that information for advancing the purpose of this AA; and
  • have a legally enforceable obligation to maintain the confidentiality of the information in accordance with the laws, policies and procedures applicable to the receiving Participant.
• If a Participant is not satisfied with how the other Participant protects confidential and/or non-publicly available information, it intends to take all appropriate measures to ensure that the situation is corrected to its satisfaction, including temporarily suspending its disclosure if necessary.
• The Participants understand that, for the purpose of carrying out functions concerning the protection of human health or safety in relation to consumer products, DG Justice and Consumers intends to disclose the confidential and/or non-publicly available information received from Health Canada through the appropriate channels to the EU Member States and for the sole purpose of this AA.
• DG Justice and Consumers intends to take all appropriate measures to ensure that EU Member States are informed of the requirement to treat any confidential and/or non-publicly available information in accordance with their applicable laws, regulations and policies, including the General Data Protection Regulation (EU) 2016/679, as well as the provisions in the current AA.
• The Participants intend to, unless the Participant providing the information consents to its disclosure (and is authorised to provide consent), make all reasonable efforts to prevent disclosure of confidential and/or non-publicly available information to other third parties and intend to:
  • Subject to the laws applicable to them, make all reasonable efforts to inform the other Participant of any request made pursuant to a judicial, legislative, or other authority to obtain confidential and/or non-publicly available information that has been received from the other Participant; and
  • If disclosure is authorised pursuant to such judicial, legislative or other authority, make all reasonable efforts to ensure that the information is disclosed in a manner that protects the information from any subsequent disclosure that is not authorised by the judicial, legislative, or other authority.

9. Modification of the AA

The Participants may jointly modify this AA.

The Participants understand that any modification of the measures needs to be endorsed by the Committee on Trade in Goods.

10. Contact Points

The Participants designate the following as their contact points for the purpose of this AA:

• For DG Justice and Consumers:
  Head of the Product Safety and Rapid Alert System Unit
  Rue du Luxembourg 40 / Luxemburgstraat 40
  1000 Bruxelles / Brussel, Belgique / Belgium
• For Health Canada:
  Manager, External Relations Division,
  Consumer Product Safety Directorate,
  Healthy Environments and Consumer Safety Branch,
  Health Canada,
  269 Laurier Avenue West,
  Ottawa, Ontario, K1A 0K9,
  Canada

11. Difference in interpretation and application

The Participants intend to resolve any difference in the interpretation and application of this AA through consultations.

12. Status

This AA is not legally binding.

13. Final Dispositions

• This AA will take effect upon its signature by the Participants and after the endorsement by the Committee on Trade in Goods, and provided the relevant CETA provisions are in force or are being provisionally applied by the Parties to CETA. The exchange of information is intended to commence once both Participants have confirmed that the technical capabilities necessary for implementation have been put in place.
• The Participants intend to make all reasonable efforts to inform each other of any changes to the laws, policies, or procedures applicable to them that may affect their treatment of confidential information and/or non-publicly available information obtained under this AA. The Participants intend to jointly review the AA, if any regulatory or legislative changes have a direct impact on it.
• Either Participant may terminate this AA by giving a prior written notice to the other Participant. The Participants may also jointly terminate this AA.
• Upon termination of this AA, the Participants should continue to protect exchanged confidential information and/or non-publicly available information from unauthorised disclosure or use in accordance with the laws, policies and procedures applicable to them.

SIGNED in duplicate at Brussels on 13 November 2018, in the English and French languages, each version being equally valid.

FOR THE DEPARTMENT OF HEALTH OF CANADA, Tolga YALKIN Director General Consumer Product Safety Directorate.

FOR THE DIRECTORATE-GENERAL FOR JUSTICE AND CONSUMERS OF THE EUROPEAN COMMISSION, Tiina ASTOLA Director-General.

Annex I

Product categories (consumer products)

in RAPEX and in RADAR

Consumer product categories from RAPEX

• Chemical Products
• Childcare Articles and Children’s Equipment
• Clothing, Textiles and Fashion Items
• Communication and Media Equipment
• Construction Products
• Cosmetics
• Decorative Articles
• Electrical Appliances and Equipment
• Food-imitating products
• Furniture
• Gadgets
• Gas Appliances and Components
• Hand Tools
• Hobby/Sports Equipment
• Jewellery
• Kitchen/Cooking Accessories
• Laser Pointers
• Lifts
• Lighters
• Lighting Chains
• Lighting Equipment
• Machinery
• Pressure Equipment/Vessels
• Protective Equipment
• Recreational Crafts
• Stationery
• Toys
• Other

Consumer product categories from RADAR

• Chemicals
• Childcare
• Clothing and Accessories
• Construction
• Containers/Wrappings
• Cosmetics
• Hobby/Craft Items
• Household Items
• Household Textiles
• Jewellery (excluding watches)
• Laser pointers
• Lighters/Matches
• Miscellaneous
• Sports/Leisure
• Toys
• Warning/Protection

Annex II

Data fields

Data fields from RAPEX / Data fields from RADAR

• Notification number / Case Number
• Legal basis / No Homologue
• Notifying country / Notifying Country: Canada
• Date of case / Date of case
• Product Category / Product Category
• Customs code / HS Code when it becomes available.
• Product name / Product Brand and Name
• Brand / Product Brand and Name
• Type/Number of Model/Bar code/Batch code / Type/number of model/Bar code/Batch code
• Is the product counterfeit?  / No Homologue
• Description and dimensions of product & packaging / Product Description
• Country of origin / Country of origin
• Manufacturer (Name, Address, City, Country) / Manufacturer (Name, Address, City, Country)
• Exporter (Name, Address, City, Country) / Exporter (Name, Address, City, Country)
• Is the product sold online? / No Homologue
• Details / No Homologue
• Proof of conformity / Proof of Standards Compliance
• Nature of danger / risk / Primary Hazard and Hazard NoteSummary of tests and risk assessments / Analyst reports and risk assessments
• Standards or regulations applicable / Applicable regulations
• Legal provisions and standards against which the product was tested and did not comply; / Requirements not met, prohibitions violated
• Accidents which happened / Incident description
• Voluntary measures / Voluntary measures
• Compulsory measures / Compulsory measures
• Photographs or drawing of product / Images of product
• Copy of certificates, test reports and risk assessments (following a request from Health Canada when a specific issue warrants more information) / Proof of accreditation and/or certification