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FDA
The Food and Drug Administration (or FDA) is an agency of the United States Department of Health and Human Services established in 1906.
FDA's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers.
Some products -- such as new drugs and complex medical devices -- must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products -- such as x-ray machines and microwave ovens -- must measure up to performance standards. And some products -- such as cosmetics and dietary supplements -- can generally be marketed with no prior approval.
CALIFORNIA PROPOSITION 65
Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code, Chapter 6.6, Sections 25249.5 through 25249.13) was enacted as a ballot initiative in November 1986. The requirements imposed by Proposition 65 on persons doing business in California apply to chemicals that appear on the list. The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment is designated by the Governor as the lead agency for Proposition 65 implementation.
Proposition 65 requires the Governor to publish a list of chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm. Nearly 580 chemicals have been listed as of September 1, 1996.
Proposition 65 imposes certain requirements that apply to chemicals that appear on this list. These requirements are designed to protect California's drinking water sources from contamination by these chemicals, to allow California consumers to make informed choices about the products they purchase, and to enable residents or workers to take whatever action they deem appropriate to protect themselves from exposures to harmful chemicals.
The list contains a wide range of chemicals, including dyes, solvents, pesticides, drugs, food additives, and by-products of certain processes. These chemicals may be naturally occurring or synthetic. Some of them are ingredients of common household products, others are specialty chemicals used in very specific industrial applications.
A chemical is listed if the "state's qualified experts"--an independent panel of scientists and health professionals appointed by the Governor--find that the chemical has been clearly shown to cause cancer or birth defects or other reproductive harm.
Chemicals are also listed if:
A body considered to be "authoritative" by the State's qualified experts has formally identified the chemical as causing cancer or reproductive toxicity; or
A state or federal government agency has formally required the chemical to be labeled or identified as causing cancer or reproductive toxicity.
Proposition 65 applies to all persons doing business in California, except those businesses which have fewer than 10 employees. Governmental entities and drinking water utilities are exempt.
Businesses must, twelve months after a chemical is listed, provide a "clear and reasonable warning" before knowingly and intentionally exposing anyone to a listed chemical. Twenty months after a chemical is listed, businesses are prohibited from knowingly discharging or releasing the chemical into water or air, or into land where such chemical passes or probably will pass into any source of drinking water. Warning is required and discharge is prohibited unless the business responsible can show that the exposure or discharge pose no significant risk.
The Office of Environmental Health Hazard Assessment expect to introduce, by November 1997, a proposal to establish and define procedures for "delisting" when appropriate due to new scientific information, chemicals that had been placed on the list based on findings made by the State's qualified experts.
2005/31/EEC
COUNCIL DIRECTIVE of 15 October 1984
on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs (84/500/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
METHODS OF ANALYSIS FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM
1. Object and field of application
The method allows the specific migration of lead and/or cadmium to be determined.
2. Principle
The determination of the specific migration of lead and/or cadmium is carried out by atomic absorption spectrophotometry.
3. Reagents
- All reagents must be of analytical quality, unless otherwise specified.
- Where reference is made to water, this always means distilled water or water of equivalent quality.
3.1. 4 % (v/v) acetic acid, in aqueous solution
Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.
3.2. Stock solutions
Prepare stock solutions containing 1 000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution (3.1).
4. Instruments
4.1. Atomic absorption spectrophotometer
The instrument's detection limit for lead and cadmium must be equal to or lower than:
- 0,1 mg/litre for lead,
- 0,01 mg/litre for cadmium.
The detection limit is defined as the concentration of the element in 4 % acetic acid (3.1) which gives a signal equal to twice the background noise of the instrument.
5. Method
5.1. Preparation of the sample
The sample must be clean and free from grease or other matter likely to affect the test.
Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 ℃. Rinse the sample first in tapwater and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested should not be handled after it has been cleaned.
5.2. Determination of lead and/or cadmium
- The sample thus prepared is tested under the conditions laid down in Annex I.
- Before taking the test solution for determining lead and/or cadmium, homogenize the content of the sample by an appropriate method which avoids any loss of solution or abrasion of the surface being tested.
- Carry out a blank test on the reagent used for each series of determinations.
- Carry out determinations for lead and/or cadmium under appropriate conditions by atomic absorption spectrophotometry.
DISWASHER SAFE TEST
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