Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/21

24 December 2008

Dear Sirs,

Commercial Information Circular No. 656/2008

US : Requirements for Accreditation of Third Party Conformity Assessment Bodies to Test the Lead Content in Children's Metal Jewelry 

The US Consumer Product Safety Commission (CPSC) published in the Federal Register (FR) notice of 22 December 2008 setting out the requirements for the accreditation of third party conformity assessment bodies to assess conformity with the 600 parts per million (ppm) and 300 ppm lead content limits in metal and metal alloy parts of children's metal jewelry established by the US Consumer Product Safety Improvement Act of 2008 (CPSIA). These accreditation requirements are effective on 22 December 2008 and comments on them are due by 21 January 2009. A copy (pdf format) of the FR notice is appended to this circular for reference.

DETAILS

2. Children's products are those designed or intended for use primarily by children 12 years old and younger. Under Section 101(a)(2) of the CPSIA, a limit of 600 ppm of lead in any part of a children's product, including an item of children's metal jewellery, becomes effective on 10 February 2009. Each importer or US domestic manufacturer of such products manufactured on or after that date must issue a certificate of conformity with the 600 ppm limit. That certificate must be based on a test of each product or a representative testing programme. 
    
3. Subsequently, for children's metal jewellery products manufactured after 23 March 2009, each importer and domestic manufacturer must have metal and metal alloy parts of such products tested by a laboratory whose accreditation to do so has been accepted by the CPSC in accordance with this FR notice and must issue a certificate of compliance with the 600 ppm lead limit for the metal and metal alloy parts of the jewellery based on that testing. When the 300 ppm limit of Section 101(a)(2)(B) of the CPSIA goes into force on 14 August 2009, each importer and domestic manufacturer of children's metal jewellery subject to that limit must have metal and metal alloy parts of such products tested by a laboratory whose accreditation to do so has been accepted by the CPSC and must issue a certificate of compliance with the limit based on that testing.

Baseline third party laboratory accreditation requirements

4. Baseline accreditation of each category of laboratory to the International Organization for Standardization (ISO) Standard ISO/IEC 17025:2005 - General Requirements for the Competence of Testing and Calibration Laboratories is required. The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement (ILAC–MRA) and the scope of the accreditation must include testing for lead content in metal and metal alloy parts of children's metal jewelry in accordance with the CPSC Standard Operating Procedure (SOP) for Determining Total Lead (Pb) in Children's Metal Products (including Children's Metal Jewelry), CPSC - CH - E1001 - 08, available at http://www.cpsc.gov/about/cpsia/CPSC-CH-E1001-08.pdf. A listing of ILAC - MRA signatory accrediting bodies is available on the Internet at http://ilac.org/membersbycategory.html. A true copy in English of the accreditation and scope documents demonstrating compliance with these requirements must be registered with the CPSC electronically.

Additional accreditation requirements for firewalled laboratories

5. Firewalled laboratories seeking accredited status must submit to the CPSC for review copies in English of their training documents showing how employees are trained to notify the CPSC immediately and confidentially of any attempt by the manufacturer, private labeller or other interested party to hide or exert undue influence over the laboratory's test results. This additional requirement applies to any laboratory in which a manufacturer or private labeller of children's metal jewelry to be tested by the laboratory for conformity with lead content requirements to support certification owns a 10 percent or greater interest. The CPSC must formally accept, by order, the accreditation application of a laboratory before the laboratory can become an accredited firewalled laboratory.

Additional accreditation requirements for governmental laboratories

6. In addition to the baseline accreditation requirements, the CPSIA permits accreditation of a laboratory owned or controlled in whole or in part by a government if:

• To the extent practicable, manufacturers or private labellers located in any nation are permitted to choose laboratories that are not owned or controlled by the government of that nation;
   
• The laboratory's testing results are not subject to undue influence by any other person, including another governmental entity;
   
• The laboratory is not accorded more favorable treatment than other laboratories in the same nation who have been accredited;
   
• The laboratory's testing results are accorded no greater weight by other governmental authorities than those of other accredited laboratories; and
   
• The laboratory does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the laboratory's conformity assessments.

The CPSC will accept the accreditation of a governmental laboratory if it meets the baseline accreditation requirements and meets the conditions stated above. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

Way for a laboratory applying for acceptance of its accreditation

7. The CPSC has established an electronic accreditation acceptance and registration system accessed via the CPSC's website at http://www.cpsc.gov/about/cpsia/labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC-MRA accreditation certificate and scope statement and firewalled laboratory training document(s), if relevant. CPSC staff reviews that submission for accuracy and completeness. In the case of baseline third party laboratory accreditation and accreditation of governmental laboratories, when that review and any necessary discussions with the applicant are satisfactorily completed, the laboratory in question is added to the CPSC listing of accredited laboratories at http://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled laboratory seeking accredited status, when the review is complete, the staff transmits its recommendation on accreditation to the CPSC for consideration. If the CPSC accepts a staff recommendation to accredit a firewalled laboratory, that laboratory will then be added to the CPSC list of accredited laboratories. In each case, the CPSC will electronically notify the laboratory of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language. Once the CPSC adds a laboratory to the list, the laboratory may then commence testing of children's products to support certification of compliance with the requirements for lead content in metal and metal alloy parts of children's metal jewellery by the importer or US domestic manufacturer.

Limited acceptance of children's product certifications based on third party laboratory testing prior to CPSC acceptance of accreditation

8. The CPSC will accept a certificate of compliance with the lead content limits in metal and metal alloy parts of children's metal jewelry based on total lead content testing performed by an accredited third party or governmental laboratory on or after 16 May 2008, 90 days prior to 14 August 2008 (the date of enactment of CPSIA) and thus prior to the CPSC's acceptance of the laboratory's accreditation if:

• The laboratory was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test;
   
• The accreditation scope in effect for the laboratory at that time expressly included testing using the 3 February 2005 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewellery at http://www.cpsc.gov/businfo/pbjeweltest.pdf and/or the 2008 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewellery, CPSC-CHE1001-08, available at http://www.cpsc.gov/about/cpsia/CPSC–CH–E1001–08.pdf;
   
• Total lead testing was conducted and the analytical results of the testing for total lead do not exceed the 600 ppm or 300 ppm total lead limit, as applicable;
   
• The laboratory's accreditation application is accepted by the CPSC under the procedures of the FR notice not later than 20 February 2009; and
   
• The laboratory's accreditation and inclusion of the reference to the 2005 and/or the 2008 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewellery in its scope remains in effect through the effective date for mandatory third party testing and certification for limits on total lead content in children's metal jewellery as established by the CPSIA.

Testing performed by a firewalled laboratory prior to CPSC acceptance of its accreditation cannot be used as the basis for certification by an importer or US domestic manufacturer with a 10 percent or greater ownership interest in the laboratory of compliance with the lead content limits in metal and metal alloy parts of children's metal jewelry.

ENQUIRIES

9. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.

Yours faithfully,

(Miss Bonny CHAO)

for Director-General of Trade and Industry