CSA Z76.1:21

National Standard of Canada

Reclosable child-resistant packages

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  CSA Z76.1:21

  August 2021

  
  

  Title: Reclosable child-resistant packages

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National Standard of Canada

CSA Z76.1:21

Reclosable child-resistant packages

®A trademark of the Canadian Standards Association, operating as “CSA Group”

Published in August 2021 by CSA Group

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ISBN 978-1-4883-3647-8

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Contents

Technical Committee on Child-Resistant Packaging 4

Preface 6

1. Scope 7

   1. General 7

   2. Requirements 7

   3. Testing 7

   4. Nonreclosable child-resistant packages 7

   5. Terminology 7

   6. Dual dimensions 7

      
      

2. Reference publications 8

   
   

3. Definitions 8

   
   

4. General requirements 9

   1. Appearance 9

   2. User attributes 9

   3. Packaging operation and design 9

   4. Materials 9

   5. Finish 9

   6. Retention of protocol test summaries 9

      
      

5. Detailed requirements 9

   1. General 9

      1. Evaluation criteria 9

      2. Choosing a protocol 9

   2. Full protocol testing 10

   3. Sequential protocol testing 10

   4. Evaluation of similar models of a child-resistant package 10

   5. Physical testing of a CRP 10

      1. Life test 10

      2. Leakage test 10

         
         

6. Records and reports 10

   1. Protocol test — Minimum general information 10

   2. Child protocol test 11

      1. Minimum information 11

      2. Report format 11

   3. Senior adult protocol test 12

      1. Minimum information 12

      2. Report format for senior adult protocol test 12

         
         

7. Markings and instructions 13

   1. Marking of reclosable packages 13

      1. General 13

      2. Container or shipping carton 13

   2. Instructions 13

      
      

8. Protocol testing 13

   1. Child-resistant effectiveness test 14

      1. Preparation of test samples 14

      2. Test panel 14

      3. Test panel samples 14

      4. Test procedures 14

      5. Test description 14

   2. Senior-adult-use effectiveness test 15

      1. General 15

      2. Test panel 15

      3. Screening procedure 16

      4. Test procedures 16

      5. Test description 16

   3. Senior adult reclosing test 18

      1. General 18

      2. Test description 18

         
         

9. Assessment of sequential protocol testing 18

   1. General 18

   2. Sequential method 18

      
      

10. Assessment of full protocol testing 19

    1. Child-resistant effectiveness 19

       1. Calculation of child-resistant effectiveness 19

       2. Child-resistant effectiveness requirement 19

    2. Senior adult-use effectiveness 19

       1. Calculation of senior adult-use effectiveness 19

       2. Senior adult-use effectiveness requirement 19

          
          

11. Protocol array 19

    1. General 19

    2. Model array 19

       
       

12. Physical testing 20

    1. General 20

       1. Samples 20

       2. Test methods 20

       3. Material specifications 20

       4. Initial testing 20

       5. Subsequent testing 20

       6. Scope of testing 20

       7. Results 21

    2. Specific child-resistant systems 21

       1. Continuous-thread child-resistant systems 21

       2. Snap cap child-resistant systems 22

       3. Other child-resistant packages 23

    3. Life test 23

    4. Leakage test 23

       1. Sample selection 23

       2. Test procedure 23

Annex A (informative) — Guidelines for persons supervising tests involving children 26

Annex B (informative) — Sample calculations for the senior adult reclosing test 27

Technical Committee on Child-Resistant Packaging

L. Mitchell Dixon Great Lakes Marketing Associates,

Toledo, Ohio, USA

Category: User Interest

Chair

P. Chowhan Health Canada, Risk Management Bureau, CHPSD, Ottawa, Ontario, Canada

Category: Government and/or Regulatory Authority

Vice-Chair

D. Borter Centor Inc., Millersburg, Ohio, USA

Category: Producer Interest

M. Bussiere Richards Packaging Inc., Mississauga, Ontario, Canada Category: Producer Interest

P. D. Chantal Health Canada,

Ottawa, Ontario, Canada

Category: Government and/or Regulatory Authority

P. A. Dubé Institut national de santé publique du Québec, Québec, Québec, Canada

Category: General Interest

T. D. Intini Intini Marketing Inc., Brossard, Québec, Canada Category: Producer Interest

1. Mosher IWK Regional Poison Centre, Halifax, Nova Scotia, Canada Category: General Interest

   
   

   
   

2. Perkins Bird Dog Marketing Group, Lancaster, Pennsylvania, USA Category: User Interest

Non-voting

1. Scorpio United States Consumer Product Safety Commission, Bethesda, Maryland, USA

   Non-voting

   
   

   
   

2. Tscheng Institute for Safe Medication Practices Canada, Toronto, Ontario, Canada

Non-voting

R. A. Ward Perritt Laboratories, Inc., Hightstown, New Jersey, USA Category: User Interest

T. Wojcik Winpak,

Vaudreuil-Dorion, Québec, Canada

Non-voting

C. Cortissoz CSA Group,

Toronto, Ontario, Canada

Project Manager

Preface

This is the sixth edition of CSA Z76.1, Reclosable child-resistant packages. It supersedes the previous editions published in 2016, 2006, 1999, 1990, and 1979.

This Standard is restricted to reclosable packages. The Standard does not include packages with a non- child-resistant mode.

This edition includes the following changes:

1. general updates (e.g., references, terminology, and figures);

2. updated child test result recording requirements;

3. revision to the child-resistant testing site location requirements; and

4. removal of the communication to the children allowing the use of teeth during child-resistant testing.

   
   

   This Standard was prepared by the Technical Committee on Child-Resistant Packaging and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee.

   This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Notes:

   1. Use of the singular does not exclude the plural (and vice versa) when the sense allows.

   2. Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.

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      1. define the problem, making reference to the specific clause, and, where appropriate, include an illustrative sketch;

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      3. where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.

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   5. This Standard is subject to review within five years from the date of publication. Suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiries@csagroup.org and include “Proposal for change” in the subject line:

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      2. relevant clause, table, and/or figure number;

      3. wording of the proposed change; and

      4. rationale for the change.

CSA Z76.1:21

Reclosable child-resistant packages

1. Scope

   
   

   1. General

      This Standard applies to packages for consumer products available in liquid or solid form that incorporate reclosable child-resistant features that restrict children’s ability to gain access to the contents of the packages. Such packages include (but are not limited to) packages with a continuous- thread, lug-finish, or snap closure.

      
      

   2. Requirements

      This Standard includes requirements for the construction, performance, and marking of child-resistant packages, and for the instructions to be provided with such packages.

      
      

   3. Testing

      This Standard specifies the minimum level of physical tests for ensuring that subsequent production lots comply with this Standard, including

      1. child-resistant effectiveness test;

      2. senior-adult-use effectiveness test; and

      3. senior-adult reclosing test.

      
      

   4. Nonreclosable child-resistant packages

      This Standard does not apply to nonreclosable child-resistant packages or features.

      
      

   5. Terminology

      In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

      Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

      
      

      Notes to tables and figures are considered part of the table or figure and may be written as requirements.

      
      

      Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

      
      

   6. Dual dimensions

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.