| Chemical & Toxicology |
LHAMA CertificationThe U.S. Consumer Product Safety Commission (U.S. CPSC) regulation 16 CFR 1500.14 (b)(8)) requires that art materials be evaluated for compliance with the Labeling of Hazardous Art Materials Act (LHAMA) according to the standards of the American Society of Testing and Materials (ASTM D-4236). ASTM D-4236 describes a procedure for developing precautionary labels for art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This practice concerns those chronic health hazards known to be associated with a product (or components of a product) that in the opinion of a toxicologist has the potential to produce a chronic adverse health effect. This practice applies to art materials packaged in sizes intended for individuals of any age who use a product as intended or under circumstances involving reasonable foreseeable misuse. A manufacturer or repackager of an art material formulation/reformulation provides information to a toxicologist for review. The toxicologist is required to keep the product formulations confidential. In evaluating a specific product for potential chronic adverse health effects, the toxicologist will take into consideration the chemical composition of the product, the current well-established scientific knowledge of the chronic toxic potential of each component and the total formulation, specific physical/chemical form of the product, the bioavailability, concentration, amounts, potential for known synergisms and antagonisms of each potentially chronic toxic component (and known decomposition or combustion products) found in the formulation and opinions of various regulatory agencies and scientific bodies. Based on this evaluation, a Statement of Conformance and, if appropriate, recommended precautionary labeling for the product will be issued. The purpose of the Conformance Statement/Labeling is to inform the purchaser, at the time of purchase, of the product’s compliance with the standard and, if appropriate, precautions to be taken when using the product. ICQ - USA evaluates art materials for compliance with the LHAMA Certification Regulations and ASTM Standards; including recommending appropriate precautionary labeling statements if needed. ICQ - USA uses the services of a Board-Certified Toxicologist. Toxicological Risk AssessmentsA Toxicological Risk Assessment (TRA) addresses all potential toxic risks (acute and chronic toxicity, corrosive/irritation potential to skin, eyes and mucous membranes and sensitization [allergic] risks) for specific chemicals or consumer products in accordance with appropriate regulations. To evaluate a specific product for potential toxic risks, ICQ - USA needs the name of the product, a quantitative list of the ingredients in the product (each ingredients identified by IUPAC chemical name and Chemical Abstract Services Registry Number, CASRN) and the weight [or volume] of material in the largest size consumer product. If one of the ingredients in the product is a mixture, a current Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) for that ingredient may be required. On receipt of this information, ICQ - USA will prepare a draft TRA report for the client. The draft TRA will include background information, potential exposures information (exposure assessment), toxicity information (toxicity assessment) and risk assessment information. After the draft report is reviewed by the client, modifications and suggestions offered by the client to improve the report will be incorporated into the final TRA. The final TRA report may be used by the client for submission to regulatory authorities and other interested parties to document the known potential health risks (if any) to consumers who may use the product as intended or under circumstances involving reasonable foreseeable misuse. A product that poses no potential health risks must be considered to be a safe product. ICQ - USA uses the services of a Board-Certified Toxicologist. Toxic Substances Control Act (TSCA)The Toxic Substances Control Act (TSCA) is intended to help protect the health of humans and the environment from unreasonable risks posed by unknown chemicals in imported products (including consumer products). The U.S. EPA/U.S. Customs are responsible for keeping chemicals out of the U.S. which have not undergone adequate risk screening. A list of TSCA-approved approved chemicals has been created by the EPA and the list is periodically updated. If a product contains a chemical that is not on the TSCA-approved list, additional testing may be required by the EPA before that product can be imported. ICQ - USA uses qualified professionals with many years of experience to determine if the chemical ingredients in consumer products comply with the TSCA Regulations. Importers of products that contain chemical substances must provide written certification that those items or devices are subject to the TSCA regulations (a positive certification statement) or not (a negative certification statement) or the U.S. Customs Service will not permit those products to be imported. Immediate benefits of using the services of ICQ - USA to determine if the chemicals in your product are in compliance with TSCA include peace of mind and Prompt Service. The TSCA Certification Statement must be signed by an officer or a representative of the company importing that product and submitted to US Customs before the product can be imported into the US. Most consumer products are expected to contain only TSCA-approved chemicals and, therefore they are expected to qualify for certification statements for US Customs to permit their importation. Safe Drinking Water and Toxic Enforcement Act of 1986 (SDWTEA)The State of California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (SDWTEA, also known as Proposition 65) regulates consumer products containing carcinogens or reproductive toxicants. This Act requires that a consumer product that is sold in California be appropriately labeled if that product contains a substance that exceeds the “Safe Harbor” level for carcinogens and reproductive toxicants that has been established by California’s EPA (Cal EPA) when a consumer uses that product. Lists of substances and their Safe Harbor levels for carcinogens (no significant risk levels) and reproductive toxicants (maximum allowable dose levels) are periodically published by California’s EPA. ICQ - USA uses the services of a Board-Certified Toxicologist.
European Market - REACH & SVHCOn 1 June 2007 REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) regulation has entered into force in Europe. REACH involves all subjects that:
Not just chemical products are included (substances, preparations), but also products involved in other kinds of industrial activity such as cleaning products, varnishes, cosmetics, candles, as well as articles like apparel, furniture, toys, childcare articles, electric equipment, etc. Scope of the regulation is to evaluate all substances imported/manufactured/used within the Community in order to ensure a high level of protection of human health and the environment. This scope is reached also through the identification of substances of very high concern (SVHC) since their use and presence within products are subject to specific duties. Indeed, starting from 28 October 2008, every company within the European Community shall know if its products contain one or more SVHC candidate for authorisation. The list of those SVHC is constantly under revision by the European Chemical Agency, therefore companies need to date and get information on new substances included within the list. Services proposed can be differentiated on many levels and modulated in relation to the needs of every client, including:
Even companies that are not responsible for initially placing products on the European market (example: distributors, downstream users, etc) shall identify their role with respect to REACH in order to be able to identify the actions that shall be undertaken to satisfy the requirements of the regulation. ICQ is at your disposal to support you toward REACH compliance. |
