Vol. 141, No. 5 — March 7, 2007

Registration
SOR/2007-30 February 15, 2007

HAZARDOUS PRODUCTS ACT

Regulations Amending the Hazardous Products (Glazed Ceramics and Glassware) Regulations

P.C. 2007-181 February 15, 2007

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 5 (see footnote a) of the Hazardous Products Act, hereby makes the annexed Regulations Amending the Hazardous Products (Glazed Ceramics and Glassware) Regulations.

REGULATIONS AMENDING THE HAZARDOUS PRODUCTS (GLAZED CERAMICS AND GLASSWARE) REGULATIONS

AMENDMENTS

1. The title of the Hazardous Products (Glazed Ceramics and Glassware) Regulations (see footnote 1) is replaced by the following:

GLAZED CERAMICS AND GLASSWARE REGULATIONS

2. Section 1 of the Regulations is amended by adding the following in alphabetical order:

"good laboratory practices" means practices similar to those set out in the OECD Principles of Good Laboratory Practice, Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM (98) 17, the English version of which is dated January 21, 1998 and the French version of which is dated March 6, 1998. (bonnes pratiques de laboratoire)

3. Section 5 of the Regulations is replaced by the following:

5. No drinking vessel with a distinctive exterior decorative pattern within 20 mm of the rim, when tested in accordance with the method set out in item 2 of the schedule, shall release lead in excess of 4 mg/L or cadmium in excess of 0.4 mg/L.

4. (1) The portion of item 1 of the schedule to the Regulations before paragraph (a) is replaced by the following:

1. To determine whether a product releases lead or cadmium, the following method, which is based on the International Organization for Standardization standard ISO 6486-1:1999, Ceramic ware, glass-ceramic ware and glass dinnerware in contact with food — Release of lead and cadmium — Part 1: Test Method, second edition, 1999-12-15, shall be used:

(2) Paragraph 1(e) of the schedule to the Regulations is replaced by the following:

(e) take an aliquot of the extraction solution and, within 8 hours, analyze the solution using an analytical technique that is in accordance with good laboratory practices; and

5. (1) The portion of item 2 of the schedule to the Regulations before paragraph (a) is replaced by the following:

2. To determine whether a drinking vessel bearing a distinctive exterior decorative pattern within 20 mm of the rim releases lead or cadmium, the following method, which is based on a standard of the American Society for Testing and Materials (ASTM C927-80), reapproved 2004, Standard Test Method for Lead and Cadmium Extracted from the Lip and Rim Area of Glass Tumblers Externally Decorated with Ceramic Glass Enamels, shall be used:

(2) Paragraph 2(g) of the schedule to the Regulations is replaced by the following:

(g) take an aliquot of the extraction solution and, within 8 hours, analyze the solution using an analytical technique that is in accordance with good laboratory practices; and

COMING INTO FORCE

6. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

The purpose of this regulatory initiative is to further restrict the limits for leaching of lead and cadmium from the lip and rim area of drinking vessels with a distinctive exterior decorative pattern. This is accomplished by amending section 5 of the Hazardous Products (Glazed Ceramics and Glassware) Regulations pursuant to the Hazardous Products Act to reflect the current industry standard for the lip and rim area of drinking vessels set by the Society of Glass and Ceramic Decorators (SGCD) in 1999.

This regulatory amendment is in line with Health Canada's commitment to:

• eliminate unnecessary lead exposure in children through its proposed Lead Risk Reduction Strategy for Consumer Products;
• reduce the exposure of the Canadian public to heavy metals such as lead and cadmium; and
• protect the Canadian public against risk factors over which they have little control.

Lead oxide is used in glazes as a flux or a substance to cause or promote melting. Advantages of lead glazes include:

• a lower melting point and gradual melting;
• a smooth and bright glaze, free from blemishes;
• a fairly low coefficient of expansion, making it fit for most pottery and glassware without formation of a network of cracks in the glaze; and
• the ability to produce a variety of finishes (clear, bright, opaque, matte or textured) as well as rich and brilliant colours in various hues.

Cadmium sulfide is used in glazes as a light yellow or orange pigment.

Appreciable amounts of lead and cadmium can leach from these glazes into foods, especially foods that are acidic. Ingestion of lead and cadmium can have serious health consequences. Lead can cause headache, weakness, fatigue, joint pain, nausea, abdominal cramps and vomiting. Continued exposure to low amounts of lead can affect the brain and nervous system, causing forgetfulness, depression, memory loss and disturbances in physical and mental performance. Lead exposure can also cause anaemia. High amounts of lead can damage the brain and kidneys, affect male fertility, and increase the risk of miscarriages, stillbirths and premature deliveries in pregnant women. The risk of lead poisoning is higher in children because their developing bodies absorb more lead, eliminate less lead, and are more sensitive to lead's damaging effects. Exposure to low amounts of lead while in the womb, during infancy or early childhood can result in lower body size, behavioural problems such as hyperactivity, learning disabilities and reduced intelligence. Very high amounts of lead can cause convulsions, reversible kidney damage, permanent brain damage, coma and death. High amounts of cadmium can cause abdominal pain, burning sensation, nausea, vomiting, diarrhea, muscle cramps and dizziness. Continued exposure to low amounts of cadmium can cause kidney damage and fragile bones. Studies in animals show that exposure to high amounts of cadmium during pregnancy causes behavioural and learning disabilities in the young.

The Hazardous Products Act prohibits or restricts the advertisement, sale, and importation of products which are or are likely to be a danger to the health or safety of the public. Under the authority of the Hazardous Products Act, the Hazardous Products (Glazed Ceramics) Regulations were introduced in 1972 to reduce the risk of lead and cadmium poisoning from glazed ceramics likely to be used for preparing, serving or storing food. In 1998, these Regulations were replaced by the current Hazardous Products (Glazed Ceramics and Glassware) Regulations to:

• lower the exposure of the public to lead and cadmium from glazed ceramics likely to be used for food;
• extend the leachable lead and cadmium limits to glassware with a coating, glaze or decoration;
• harmonize with the United States Food and Drug Administration's (FDA) leachable lead and cadmium limits for glazed ceramic foodware;
• facilitate industry's compliance; and
• facilitate Health Canada enforcement activities.

Section 5 of the current Hazardous Products (Glazed Ceramics and Glassware) Regulations restricts the limits for leaching of lead and cadmium from the lip and rim area of drinking vessels with a distinctive exterior decorative pattern within 20 mm of the rim to 25 mg/L and 1.75 mg/L, respectively. These limits were adopted from the industry standard for the lip and rim area of drinking vessels set by the SGCD in 1993. In 1999, the SGCD lowered these limits to 4 mg/L and 0.4 mg/L for lead and cadmium, respectively, to:

• address public and media concerns regarding the increased presence of toxic heavy metals such as lead and cadmium in foodware;
• ensure public safety with respect to these products; and
• ensure environmental safety with respect to these products.

These limits were reapproved by the SGCD in 2004. The amendments to the current Regulations are made to reflect this SGCD standard. In addition, a requirement that evaluations of leachate lead and cadmium concentration be based on test data of sufficient quality, rigour and reproducibility has been added as a basic principle in this Regulation. The reference to OECD "good laboratory practices" ensures that Health Canada and manufacturer selected test methods satisfy the manner in which laboratory studies are planned, performed, monitored, recorded and reported. It also ensures that proper documentation is kept which can help support the results given by a manufacturer if Health Canada disputes or wishes to recreate their test.

The original SGCD standard for the lip and rim area of drinking vessels was officially endorsed in 1979 by the Food & Drug Administration (FDA), Environmental Protection Agency, and Consumer Product Safety Commission (CPSC) of the United States federal government, but was never enforced. The FDA continues to endorse SGCD's standards in this area, although they do not formally regulate lip and rim area leaching.

The impact on industry of amending section 5 of the Hazardous Products (Glazed Ceramics and Glassware) Regulations to reflect the 1999 industry standard was determined using data on leachable lead and cadmium levels in drinking vessels from a glazed ceramics and glassware survey conducted by Health Canada in 1998-1999, i.e., at or before the time the current industry standard came into effect. Almost 90% of the glazed ceramic drinking vessels tested, but less than 60% of the glassware tested, were in compliance with the revised 1999 industry standard. However, the glassware that did not meet the standard originated in countries with a market share of less than 2% in 1999. Based on Health Canada testing, the suppliers in North America have already shown they comply with the new limits for both lead and cadmium. It was concluded that amending section 5 of the Hazardous Products (Glazed Ceramics and Glassware) Regulations to reflect the 1999 industry standard would have a negligible impact on industry, especially those in North America.

Considering that almost 90% of the drinking vessels tested in 1998-1999 were in compliance with the regulatory requirements, and the broad international scope of the SGCD, it is expected that compliance with the 1999 industry standard has improved since the survey was conducted.

Alternatives

number	descriptions
1.	Do not adopt the Regulations (status quo)
	Not adopting the Regulations will cause continued confusion for industry regarding the leachable lead and cadmium limits with which their products must comply, and will provide less assurance of safe products for the public. Compliance with leachable lead and cadmium limits that are higher than those accepted by industry will be allowed.
2.	Adopt standards other than those in the Regulations.
	Adopting other standards may result in higher incremental costs without associated benefits.

Benefits and Costs

The economic implications of the regulatory amendment were assessed by considering costs, benefits and distributional effects as economic issues.

The assessment of costs considers only incremental costs. These are the costs that arise from the regulatory amendment that occurs in addition to those costs for pre-existing activities. The total cost considered is represented by compliance costs to industry and government regulatory costs.

The assessment of benefits considers only incremental benefits. These are the additional benefits that arise because of the regulatory amendment.

The distributional assessment provides information about the societal impact of the benefits and costs of the regulatory amendment.

Costs

As industry is largely already complying with the standards set by the regulatory amendment, few additional costs are expected. Similarly, the costs to government in setting up this amendment would also be low as no additional enforcement efforts will be required.

Benefits

In the case of regulating glazed ceramics and glassware products, few incremental health benefits are expected from this action since the amendment serves to update current Regulations to those with which the industry is largely already complying. Consequently, the health benefits have already been realized from this voluntary action. Additional non-health benefits may result from any avoided confusion over required standards or performance levels, but these would also be low.

Distributional Effects

As few benefits and costs will result from the regulatory amendment, there will similarly be few distributional impacts. It is unlikely that any one societal group will be more or less affected than any other group.

Conclusion

The economic assessment has demonstrated that the Regulations will not present a significant impact on Canadian society. While the benefits would be low, so would the costs, and no observable distributional issues would result. Adopting the Regulations is the most efficient and favourable option.

Regulations create a uniform standard of safety associated with products, and thereby increases consumer protection. Regulations also establish common requirements for domestic and imported products. In addition, regulations prevent existing and future industry members, or those with less concern for consumer protection, from marketing products with higher leachable lead and cadmium levels that are no longer acceptable. Since products with higher lead and cadmium levels are typically cheaper, this could cause lost sales for those in the industry that meet the more rigorous standards. Furthermore, it compromises consumer protection. Therefore, Regulations are justified based on consumer and producer protection arguments even when few products in the marketplace will be affected by the Regulations.

Consultation

The SGCD and the United States FDA were consulted for information related to the current leachable lead and cadmium limits for the lip and rim area of drinking vessels. Health Canada's Product Safety Laboratory was consulted regarding the applicability of the existing test method to the 1999 limits. The 1999 limits were incorporated in the Regulations without further changes.

Industry accepted the inclusion of the SGCD standard for the lip and rim area of drinking vessels when the Regulations were revised in 1998. Consequently, industry is not expected to raise any concerns with this regulatory update.

Industry also accepted the inclusion of the ISO standard 6486-1 for proposed testing. Therefore the insistence of the adherence to OECD "good laboratory practice" in the Regulations is a natural extension of the ISO standard in an explicit rather than an implicit manner.

In July of 2004, a regulatory amendment information package was forwarded to about 575 industry stakeholders in Canada. None of them objected.

The Regulations were pre-published in the Canada Gazette, Part I, on October 1, 2005, with a 75-day period for stakeholder comments. Only one comment was received; the respondent advised that the 1999 standard had been re-approved by the American Society for Testing and Materials in 2004. The date in paragraph 5(1)2 of the Regulations has been changed from 1999 to 2004 to reflect this update. This change has no effect on the function of the standard.

The SCGD and the CPSC have indicated that they support Health Canada's regulatory initiative to adopt the SGCD voluntary standard.

The regulatory amendment was also posted to the Consumer Product Safety Bureau website and no comments were received.

Compliance and Enforcement

Compliance and enforcement of the Regulations will follow Departmental policy and procedures, including sampling and testing of products and follow-up of consumer and trade complaints. Action taken on non-compliant products will range from negotiation with traders for the voluntary withdrawal of these products from the market to prosecution under the Hazardous Products Act.

Contact

Sarah Sheffield
Project Officer
Chemistry and Flammability Division
Consumer Product Safety Bureau
Product Safety Programme
Healthy Environments and Consumer Safety Branch
Department of Health
Address Locator: 3504D
123 Slater Street
Ottawa, Ontario
K1A 0K9
Telephone: (613) 954-0001
FAX: (613) 952-9138
E-mail: Sarah_Sheffield@hc-sc.gc.ca

Footnote a

R.S., c. 24 (3rd Supp.), s. 1

Footnote 1

SOR/98-176

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