Regulatory

Regulatory information & test results

Article Information Sheets

BioThane products are considered articles as defined by the OSHA Hazard Communication standard 1910.1200(c) which exempts them from OSHA Safety Data Sheet (SDS) requirements. However, BioThane is committed to communicating helpful information to our customers and therefore we provide Article Information Sheets for many of the different products we sell. Article Information Sheets provide identification, safety, storage, handling, and regulatory information about the products we sell. An Article Information Sheet provides much of the same information that Safety Data Sheets (SDS) provide for chemicals. For example, the Article Information Sheets contain section numbers and headings that are similar to Safety Data Sheets. The information contained in each one of the sections is also similar to the information found in Safety Data Sheets as well.

Information presented in this article information sheet has been compiled from reliable sources. The information is accurate to the best of our knowledge, but it cannot be guaranteed to be so. We hope you find this information useful.

Article Information Sheet Downloads

REACH

REACH is a European Union regulation that aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorization and restriction of chemicals.  The Regulation also calls for the progressive substitution of the most dangerous chemicals (referred to as "substances of very high concern" SVHC) when suitable alternatives have been identified.  The list of SVHC is updated regularly.  The Regulation came into force in 2007, with the provisions being phased in over an 11 year period.  While REACH strictly covers chemicals, and not finished articles such as BioThane Coated Webbing products, the EU market is asking for finished articles to comply with REACH.  3rd party testing is covered in this regulation and BioThane Coated Webbing has conducted such testing.

CPSIA 2008

The Consumer Product Safety Improvement Act of 2008 was an amendment to the Consumer Product Safety Act of 1972, and was enacted in response to finding lead-based paint on children’s toys imported from China.  This regulation places restrictions or bans on chemicals to be used in final articles meant to be used by or on a child, with the focus on lead and phthalates.  The law assumes that chemicals in the final article can be extracted out by the child chewing on the article.  3rd party testing is covered in this regulation, and BioThane Coated Webbing has conducted such testing.

Prop 65

In 1986, California voters approved an initiative to address their concern of toxic chemicals.  The Safe Drinking Water and Toxic Enforcement Act of 1986, otherwise known as Proposition 65, requires the State to publish a list of all chemicals known to cause cancer or birth defects or reproductive harm.  This list must be updated once a year, and has grown to over 800 chemicals.  It further requires manufacturers to place a warning on their products if they contain any of these chemicals.  There are four ways in which a chemical can be put on this list via recommendation: 1) By either of two independent committees of scientists  2) By a current authoritative body (e.g. U.S. EPA), 3) By a Federal Agency (e.g. U.S. FDA), 4) Or, if the chemical meets scientific criteria and is identified in the California Labor Code.

The no significant risk dosage level is such that if a person is exposed to the chemical for 70 yrs., that person would have less than 1 in 100,000 chance of developing cancer due to that exposure.