Legislation Regulation & QCM Ink Standards
The Consumer Product Safety Act of 2008 & Phthalate Esters (11/3/08)
In August, 2008, former President Bush signed into law the Consumer Product Safety Improvement Act of 2008 (CPSIA), (H.R. 4040). The CPSIA is a very broad overhaul of the Consumer Product Safety Act, and it responds, in part, to public concerns about imported toys containing lead. Among the CPSIA's provisions are interim restrictions on three phthalates in toys and children's products and permanent restrictions on three other phthalates in toys and children's products. These restrictions became effective February 10, 2009.
Congress did not conduct extensive hearings about the safety of phthalate esters in the products affected, nor did it conduct an extensive review of which phthalates are actually used in children's products. Despite a recent, comprehensive review of the safety of phthalate esters used in these products by the Consumer Product Safety Commission, Congress nevertheless chose to take additional action with respect to phthalates in the CPSIA.
The phthalate restrictions of the CPSIA are quite limited and only apply to certain specified phthalates in particular products. The restrictions do not apply to a very broad range of consumer products used every day, such as in electronics applications (wire and cable), vinyl flooring and wall coverings, and vinyl coatings on tools. For three of the phthalates, the restriction is permanent; for three others, the restriction is temporary while a scientific review is conducted, after which the restrictions may be lifted.
DEHP, DBP, and BBP: There are permanent restrictions on the sale of children's toys and child care articles with concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). The permanent restriction became effective February 10, 2009.
DINP, DIDP, and DnOP: There are temporary (interim) restrictions on the sale of children's toys that can be placed in a child's mouth and child care articles that contain more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). Toys that can be put in the mouth are defined to include toys or parts smaller than five centimeters in dimension. Toys that cannot be put in the mouth but can be licked are not included. The interim restriction became effective February 10, 2009.
For the three "interim restriction" phthalates, the interim ban will be in place until a scientific review is completed by a special review panel called a Chronic Hazard Advisory Panel, or CHAP. The last CHAP that reviewed the safety of phthalates in children's products, with a focus on DINP, deemed them safe for used in this application with "no demonstrated health risk" to children.
The restrictions on toys only apply to toys for children ages 12
and under, and the new law refers to CPSC's 2002 guidelines for
additional age determination guidance. The restrictions on child
care articles only apply to products to facilitate sleep or
feeding, or to help with sucking or teething, for children ages 3
Children's toys and children's products will require a general conformity certification which certifies that, based on a test of each product or upon a "reasonable testing program," the toys and products comply with applicable standards. According to materials released by the CPSC on October 2, 2008, a general conformity certification is now required since the phthalate restrictions became effective February 10, 2009. Click here for more information.
The new law preempts state laws that impose similar restrictions on phthalates.
QUESTIONS AND ANSWERS ABOUT THE CONSUMER PRODUCT SAFETY IMPROVEMENT ACT OF 2008 AND PHTHALATES
- The Consumer Product Safety Act was reauthorized and now addresses phthalates. When did this happen? In August, 2008, President Bush signed into law the Consumer Product Safety Improvement Act (CPSIA) of 2008, a broad overhaul of the Consumer Product Safety Act. The new law includes some restrictions on the use of some phthalates in children's toys and child care articles. The full Act is on CPSC's website.
- Does the law cover more than just phthalates? Yes. The CPSIA is very broad. The CPSIA contains some significant changes with respect to toys and children's products. This includes restrictions on lead and phthalate content, new safety standards and test procedures and third party testing and certification for imported children's products. The law also requires mandatory product tracking labels and product registration, as well as new warnings in product advertising. The new law is so broad that its full effect won't be known for some time - much of the CPSIA implementation will be addressed through a number of new regulations and procedures that the Consumer Product Safety Commission (CPSC) will have to issue.
- What phthalates does this law apply to? The phthalate restrictions set out in the CPSIA apply to six phthalate esters: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). The CPSIA establishes a permanent ban on the sale of children's toys and child care articles with concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP), Effective February 10, 2009, the CPSIA established an interim ban on the sale of children's toys that can be placed in a child's mouth and all child care articles that contain more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP), effective February 10, 2009.
- Does this law apply to phthalates in all consumer products? No. Many of the CPSIA's provisions - including the restrictions on six phthalates - apply just to children's products, and more specifically, toys and child care articles.
- What are children's products? "Children's products" are defined as "a consumer product designed or intended primarily for children 12 years of age or younger." The CPSC issued age determination guidelines for children's products in 2002 that are referenced in the new Act and can be found here.
- What are "children's toys"? "Children's toys" include products "designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays."
- What are "child care articles"? "Child care articles" are defined as "a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething."
- There is a "permanent" restriction on certain phthalates. What does this mean? The CPSIA prohibits the sale of children's toys and child care articles with concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP).
- Is this permanent restriction in effect now? The permanent restriction took effect on February 10, 2009.
- Some phthalates will be under an "interim" restriction. What does this mean? The CPSIA establishes an interim restriction on the sale of children's toys that can be placed in a child's mouth and all child care articles that contain more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP).
CA Bill 1108
CHAPTER 672 An act to add Chapter 11 (commencing with Section 108935) to Part 3 of Division 104 of the Health and Safety Code, relating to product safety. [Approved By Governor October 14, 2007. Filed with Secretary of State October 14, 2007.]
LEGISLATIVE COUNSEL'S DIGEST
AB 1108, Ma. Children's products: phthalates. Existing law prohibits the manufacture, processing, and distribution in commerce of products containing certain chemicals found to raise health risks, including, but not limited to, polybrominated diphenyl ether. This bill, which commenced on January 1, 2009, prohibits the manufacture, sale, or distribution in commerce of certain toys and child care articles, as defined, if those products contain types of phthalates in concentrations exceeding 1/10 of 1%. This bill would also require manufacturers to use the least toxic alternative when replacing phthalates in their products and would prohibit manufacturers from replacing phthalates with certain carcinogens and reproductive toxicants.
The people of the State of California do enact as follows: SECTION 1. The Legislature finds and declares both of the following: (a) Phthalates are a class of chemicals used in polyvinyl chloride (PVC) plastic to improve flexibility and in cosmetics to bind fragrance to the product. Phthalates are used in many products intended for use by young children, including, but not limited to, teethers, toys, and soft plastic books. (b) There is extensive scientific literature reporting the hormone-disrupting effects phthalates and substantial evidence that levels of the phthalates of concern are found in humans at levels associated with adverse effects. Population studies show that virtually everyone carries some level of phthalates in their body. For the general population, the oral route of exposure is considered a major route.
SEC. 2. Chapter 11 (commencing with Section 108935) is added to Part 3 of Division 104 of the Health and Safety Code, to read:
CHAPTER 11. PHTHALATES IN PRODUCTS FOR YOUNG
108935. For the purposes of this chapter, the following terms have the following meanings:
(a) "Toy" means all products designed or intended by the manufacturer to be used by children when they play.
(b) "Child care article" means all products designed or intended by the manufacturer to facilitate sleep, relaxation, or the feeding of children, or to help children with sucking or teething.
108937. (a) Effective January 1, 2009, no person or entity shall manufacture, sell, or distribute in commerce any toy or child care article that contains di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP), in concentrations exceeding 0.1 percent.
(b) Effective January 1, 2009, no person or entity shall manufacture, sell, or distribute in commerce any toy or child care article intended for use by a child under three years of age if that product can be placed in the child's mouth and contains diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP), in concentrations exceeding 0.1 percent.
108939. (a) Manufacturers shall use the least toxic alternative when replacing phthalates in accordance with this chapter.
(b) Manufacturers shall not replace phthalates, pursuant to this chapter, with carcinogens rated by the United States Environmental Protection Agency as A, B, or C carcinogens, or substances listed as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens, or suggestive of being human carcinogens, as described in the "List of Chemicals Evaluated for Carcinogenic Potential," or known to the state to cause cancer as listed in the California Safe Drinking Water Act (Chapter 4 (commencing with Section 116270) of Part 12).
(c) Manufacturers shall not replace phthalates, pursuant to this chapter, with reproductive toxicants that cause birth defects, reproductive harm, or developmental harm as identified by the United States Environmental Protection Agency or listed in the California Safe Drinking Water Act (Chapter 4 (commencing with Section 116270) of Part 12).
An increasing number of people in Europe are viewing textiles from an ecological stand-point. This is a trend widely expounded by the media, as it highlights "Harmful substances in textiles" and "Health." In Germany, textile and clothing manufacturers, and in particular textile processors are endeavoring with success to finish their products in such a way that harmful substances in undesirable concentrations are avoided. To this purpose, a great deal of time and money is frequently invested in processing techniques. The careful selection of dyes, dyeing procedures, FFC bleaches, high-grade finishing with low formaldehyde content, products free of pesticides and heavy metals are only some of the concerns. These textiles bear no hazards for human beings.
When purchasing clothes or household linen, how can the customer recognize products which do not endanger health? A special mark, a "label for harmful substances" can certify this. Above all the following questions must be considered: what must be and can be controlled and at what limit values can it be justifiably claimed that: "According to the latest developments in science and technology, this textile product is not hazardous to the health of the wearer"? A universally valid answer to this question is being sought for by many parties.
Nine years ago the Austrian Textile Research Institute (ÖTI) in Vienna presented a test regulation for harmful substances, the ÖTN 100, and has since been testing textiles, clothes and floor coverings in accordance with it. Experience in this field does therefore exist. The first Hohensteiner Symposium "Ecology in the Textile Chain" held in October 1991 in Ettlingen, outlined the latest developments in technology and in the market for eco-textiles. Since 1991 the Hohenstein Research Institute has been carrying out pollution analyses in accordance with the "Hohensteiner Oeko-Check."
Based on this common experience the Austrian Textile Research Institute (ÖTI) and the Hohenstein Research Institute (FIH) joined together in the "International Association for Research and Testing in the Field of Textile Ecology," named "Oeko-Tex®" (Öko-Tex) for short. Their first joint task was to draw up the "Oeko-Tex® Standard 100" for testing textiles and clothes for their ecological effects on humans. The Standard contains analyses of specific substances which are ecologically hazardous for humans, and stipulates individual limit values based on scientific research. If a textile product complies with the conditions laid down in the Standard, the supplier is awarded the right to label the goods as being "Passed for harmful substances according to Standard 100." Precautions have been taken to ensure a quality control in keeping with the requirements stipulated in the Standard for products distributed on the market.
Today the International Association Oeko-Tex® consists of eleven European textile institutes (list supplied at end of this information). The Oeko-Tex® Standard 100 has now gained general recognition as a Standard for human ecology.
Testing in Germany is carried out by the Hohenstein Research Institute and three other co-opted institutes.
Central Ideas on Human Ecology
The founders of the Oeko-Tex® Standard 100 were guided by the following considerations:
The total complex of the term "ecology" in the field of textiles appears in many forms and is frequently misleading. This causes confusion in conceptual terms, if, for example, natural textiles as such, which may also be unbleached, raw or treated with "natural dyes", are emphasized as being ecological. Here, more properly we are dealing with safeguarding the ecological harmlessness of textiles and clothes deemed currently fashionable and functionally attractive.
Textile ecology becomes considerably more lucid if it is divided into three subject groups:
- Production ecology covers the processes for the extraction and production of fibers, textiles and clothes which should be environmentally beneficial. Among other things, reasonable conditions regarding clean air, water purity, waste disposal and noise control must be observed.
- Human ecology refers to the effects of clothing on the human body, as being the nearest environment. Concentrations of substances in textile goods must be avoided here, even if there is only the slightest suspicion of damaging effects on the carrier under normal conditions.
- Disposal ecology refers to the disposal of textile products either by recycling them, putting them to a further cycle of usage or to some other intended use, or by non-hazardous decomposition or safe thermal disposal without air pollution.
The consumer is chiefly interested in human ecology and is particularly sensitized in regard to this. Thus, if the textile and clothing industry wants to mark its products as being ecologically well designed, e.g. with an Eco-label, this definition must primarily refer to human ecology. To do justice to the entanglements of the international market, the criteria must be verifiable on the textile good itself. This coincides with the demand for the control of pollutants.
From the consumer's point of view ecological criteria in regard to humans play the most important role. That is why Oeko-Tex® Standard 100 refers to this subject.
And The Other Areas?
The "International Association for Research and Testing in the Field of Textile Ecology" and the "Verein für verbraucher- und umweltfreundliche Textilien" (Association for consumer-friendly and ecological textiles) are aware that a second step must be made at a later date to include production ecology in the evaluation scheme as well.
This will make it possible to reward the special efforts made by manufacturers in production processes which protect both the environment and the employees and to inform the interested consumer.
The Oeko-Tex® Standard 100
To draw up the Oeko-Tex® Standard 100 it was necessary to clarify the following points:
- Which harmful substances in textiles are ecologically relevant to humans?
- What is known about the effects of these substances?
- What concentration of a harmful substance is hazardous? According to the centuries-old statement by Paracelsus, a substance is not toxic in itself, only in its concentration.
- How does the substance reach the person? If a substance is to damage a person, it must pass from the textile to the person, thus migrating through water, by inhalation or by skin contact.
- Is it possible to test these harmful substances on textiles and clothing? What interferes with these tests?
- How can it be ensured that the testing of a sample probe or a prototype is representative for the total production over a longer period?
- How can the measures for such tests be reduced so that they are economically attainable for the supplier?
Finally, the whole procedure for the right to bear the label "Passed for harmful substances according to Oeko-Tex® Standard 100" must be transparent, so that everyone can see and check how this label was attained.
It was therefore necessary to develop norms in which concepts are defined and the conditions and procedure for awarding the label are laid down. Dynamic adjustment of these norms to current scientific developments and new legal requirements must be able to be performed at all times swiftly and without bureaucracy. DIN, EN or ISO Norms are too lengthy and not sufficiently flexible for this. The required flexibility is determined by the normative regulation Oeko-Tex® Standard 100.
The Standard 100 covers the general rules, valid for all textile goods, the organization of quality control and the operational regulations. Further regulations, such as the product classes I-IV refer to baby clothing as well as to all the initial products and accessories, which are provided for articles for babies and children up to two years old (I), products with direct contact to skin (II), products without direct contact to skin (III), and all decoration materials (IV). Each of the relevant pollutants is defined in these regulations together with the applicable limit values. Test procedures are described in Standard 200.
An essential part of the Oeko-Tex® Standard 100 is the quality control by the supplier of the goods. It must credibly ensure that the products produced and sold under this label correspond to the test samples which were awarded the right to bear the label. Spot checks of the production line permit a control.
Research and Adaptation of Testing
One of the important aims of the International Association is to promote research in the field of textile ecology, especially in regard to the updating of labels. To this end, the Oeko-Tex® undertakes its own research projects. Of prime importance however is the collecting of relevant data and research results to be processed for specific purposes. The International Association Oeko-Tex® has set up a scientific committee in which international experts from all fields touched by the issues involved contribute their knowledge and experience.
The "Verein für verbraucher- und umweltfreundliche Textilien" (Association for consumer-friendly and ecological textiles) cooperates with these bodies.
The Oeko-Tex® Institutes award the label "Passed for harmful substances according to Oeko-Tex® Standard 100" and the certification that herewith the product is ecologically safe for humans.
The application for the Oeko-Tex® mark "Confidence in Textiles . Passed for harmful substances according to Oeko-Tex® Standard 100" can be made by anyone: yarn manufacturers, weavers, knitwear producers, hosiers, finishers, clothing manufacturers and traders etc. The application for a certificate is not bound to any prerequisites or conditions.
- The applicant makes a written application to one of the Oeko-Tex® testing institutes. In Germany an application can be made to the Research Institute Hohenstein in Bönnigheim or to the Deutsche Zertifizierungsstelle in Eschborn. A detailed description of the goods to be tested must be given according to best knowledge and belief, such as the composition of the textiles, dyes, auxiliary agents etc. If possible, the safety data sheets of finishing chemicals should be submitted.
- A declaration must be submitted in which the applicant assures the correctness of his statements.
- The goods are tested at an Oeko-Tex® Test Institute.
- The applicant receives the results in the form of an expertise. This expertise refers only to the goods tested at the institute. This does not entitle the applicant to use the Oeko-Tex® mark.
- To label the article with the Oeko-Tex® mark, the applicant must guarantee in a declaration of conformity, that the goods he sells or distributes correspond at all times with the tested goods and are strictly conform with these. The applicant accepts full responsibility for this declaration. For this reason he must give a credible explanation of his quality control system. The declaration of conformity corresponds to the System of European Product Certification under EN 45 014.
- The applicant receives the Oeko-Tex® Certificate which entitles him to use the Oeko-Tex® mark for the tested article. The right to use the mark is restricted to one year (a renewal is possible).
- The test institute reserves the right to carry out spot checks on the tested goods at all times without previous notice, in order to control the constant quality standard.
The question of the cost of goods testing is not easy to answer. Charges for testing depend primarily on the article submitted. Costs can be reduced by the following:
- Omitting unnecessary tests such as the pesticide analysis for articles containing no natural fibers.
- Substituting less expensive qualitative tests for expensive quantitative tests, where applicable.
- Testing article groups rather than individual articles. An article group consists of similar products with the same basic materials, and the same pretreatment and after-treatment.
Communication between the applicant and the test institute facilitates the formation of these article groups and often reduces testing fees.
The owner of the certificate can label his products with the mark "Confidence in Textiles . Passed for harmful substances according to Oeko-Tex® Standard 100". The test number of the expertise and the name of the institute responsible for testing must be visible on the mark.
Initially it is more advantageous to print the mark on a product tag with additional explanatory information. Later it can be printed on a sticker or on a sewn label.
The Oeko-Tex® mark is available in many different languages, but always with the same graphic design. There is a central agency for the production of setting copies for individual companies.
Both the International Association Oeko-Tex® and the Oeko-Tex® Certification Office promote publicity campaigns and provide information leaflets.
Testing for harmful substances according to Oeko-Tex® Standard 100 should be understood as part of an international network. Companies must include previous and subsequent stages of production in their own quality control system. The attained quality standard is proven with the aid of the Oeko-Tex® mark and expensive double testing is unnecessary.For example, a weaver, must know where he can obtain tested yarns or clothing manufacturers must know where they can obtain tested outer materials, linings, interfacings, sewing threads, and accessories to be able to assemble a finished product. If a manufacturer has Oeko-Tex® certificates from his suppliers, he can save on testing and obtain his own certificate at minimal costs.
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