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COMPLIANCE SUMMARIES
Bisphenol A
Bisphenol A or BPA is a building block of several important polymers and polymer additives used in the production of polycarbonates.
What products contain BPA?
Out of the seven classes of plastics used in packaging applications, Bisphenol A can only be found in plastic products marked as follows:
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PVC
Some Type 3 Plastics may leach Bisphenol A | |
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OTHER
Some Type 7 Plastics may leach Bisphenol A
This includes:
Acrylic
Acrylonitrile
Butadiene Styrene
Fiberglass
Nylon
Polycarbonate
Polylactic Acid | |
Bisphenol A is NOT used during polymerization or package forming for the following:
Type 1 PET
Type 2 HDPE
Type 4 LDPE
Type 5 POLYPROPYLENE
Type 6 POLYSTYRENE
So if you DON¡¦T buy Type 3 PVC plastics or Type 7, then BPA legislation will probably not affect you.
Why is BPA such a hot button issue?
BPA has become increasingly controversial over the last few years due to fears that continued human exposure to BPA would induce chronic toxicity. Particularly with polycarbonate baby bottles exposed to heat and heated liquids that would encourage leaching of BPA into food and drink content.
Being an endocrine disruptor, BPA is suspected to have adverse health effects, primarily affecting reproduction. There has also been environmental concern over the risk posed by having BPA leach into landfills and bodies of water, consequently affecting the food chain.
At this time, BPA is not nationally regulated in the United States. The FDA as well as other foreign health and research organizations have deemed BPA to not be of sufficient concern to institute bans though there has been enough public uproar over its effects that many studies and positions are undergoing review.
Is BPA banned anywhere?
In the US, there is currently no nationwide ban on BPA though several key states have issued regulations. Canada has a specific ban as well. See below:
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UNITED STATES |
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CHICAGO ¡V BPA Free Kids Ordinance Section 7-8-637, Chapter 7-28, Municipal Code of Chicago |
Effective January 31, 2010 ¡V Bans BPA in any containers such as an empty bottle or cup to be filled with food or liquid for children under 3 years old.
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CONNECTICUT ¡V State of Connecticut Substitute House Bill No. 6572
Public Act No. 09-103 |
Effective October 1, 2011 ¡V Bans the manufacture, sale or distribution of any reusable food or beverage container with BPA, including but not limited to baby bottles, spill-proof cups, sports bottles and thermoses, and excluding, food or beverage containers intended for disposal after initial use.
Effective October 1, 2011 ¡V Bans the sale or distribution of infant formula or baby food (2 years and under) stored in a plastic container, jar or can that contains BPA.
From October 1, 2011 to October 1, 2012 ¡V Allows the sale or distribution of existing inventory of infant formula or baby food containers, jars or cans with BPA provided that the above can be proven to have been purchased or acquired prior to Oct. 1, 2011 in a quantity comparable to what was purchased for the same period of the prior year. |
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MINNESOTA ¡V Minnesota Statutes Chapter 40 Sections 325F.172 and 173 |
Effective January 1, 2010 ¡V Bans the manufacture and wholesale.
Effective January 1, 2011 - Bans retail sales.
Both of the above applies to children¡¦s products defined as an empty bottle or cup to be filled with food or liquid designed or intended by a manufacturer to be used by a child under 3 years of age. |
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NEW YORK SUFFOLK COUNTY ¡V Toxin Free Toddler and Babies Act |
Effective 90 days after filing at New York¡¦s Secretary of State, estimated late 2009 ¡V Bans BPA in children¡¦s beverage containers, defined as any bottle, cup, cup lid, straw or other container intended to be used by children under 3 years of age for the consumption of liquids. |
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CANADA |
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Health Canada |
Canada has issued a ban on polycarbonate baby bottles containing BPA, there has been no further action concerning other products. |
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EUROPEAN UNION |
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EU Directive 2004/19/EC
EFSA (European Food Safety Authority) |
Food packaging has been assigned a specific migration limit for BPA of no more than 0.6 mg/kg o5 .6ppm.
Designates a Tolerable Daily Intake (TDI ) level of .0.05 ppm per day per individual. |
PVC Tech Corp and BPA:
Regulations concerning BPA continue to evolve as governments at every level attempt to address public concern and take varying scientific assessments into account. Market reactions have resulted in numerous products being pulled off shelves as well as products being liberally branded as ¡§BPA Free¡¨ ¡V a tag that can ultimately be misleading when products are found with traces of BPA.
At PVC Tech Corp, we want to perpetuate accuracy and not confusion. Therefore, we have been more prudent and precise in our approach by indicating that BPA in specifically engineered films we produce may be ¡§low or limited¡¨. Depending on the film requirement, we have and can design custom films significantly limiting BPA to a measure of 10 MDL or below. This would be for a custom designed film produced to an application and supplied with a third party test.
Though we do not regularly stock BPA-limited films at this time, we have the ability to engineer films to certain specifications which address this concern.
CONEG and The Toxics in Packaging Legislation
CONEG stands for the Coalition of Northeastern Governors comprised of the following member states: Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island and Vermont. The coalition was the driving force in Toxics in Packaging Legislation when it created the model legislation many states adopt today.
Therefore, the regulation first created by CONEG served as a template for different states to institute regulations of their own using the language first set by CONEG. Though each state modifies the regulation to a certain extent, the spirit of the regulation remains close to the aims identified by the Model Legislation.
The Regulation
The goal of this legislation is to reduce the sum concentration levels of four incidentally introduced heavy metals, namely lead, mercury, cadmium and hexavalent chromium present in any package or packaging component to not exceed 100 parts per million by weight.
It is important to note that the 100 ppm limit applies to the combined weight of all the above metals and NOT individually.
Definitions under CONEG
It defines a Package as ¡§any container, produced either domestically or in a foreign country, providing a means of marketing, protecting or handling a product and shall include a unity package, an intermediate package or a shipping container¡KThis includes unsealed receptacles as carrying cases, crates, cups, pails, rigid foil and other trays, wrappers and wrapping films, bags and tubs.¡¨
It defines a Packaging Component as ¡§any individual assembled part of a package which is produced either domestically or in a foreign country, such as but not limited to, any interior or exterior blocking, bracing, cushioning, weatherproofing, exterior strapping, coatings, closures, inks and labels¡¨.
Please note that again, each state may issue addendums to definitions under the Model Legislation. For instance in California, the definition of Packaging Component includes ¡§dyes, pigments, adhesives, stabilizers and any other additives¡¨.
Who must comply?
Toxics in Packaging Legislation requires compliance from the following parties:
Manufacturers and/or Suppliers of Packaging and Packaging Components
Product Manufacturers or Distributors who use Packaging
How to Comply?
Under the Model Legislation, manufacturers and suppliers of packaging and packaging components must submit a Certificate of Compliance stating that the package is in compliance with the requirements of the law to the purchaser of these items.
The certificate must be:
- Based on verifiable evidence that no intentional addition of the four metals have occurred.
- Signed by an authorized official of the manufacturing or supplying company.
- Must be kept on file for as long as the packaging is in use.
- Must contain any relevant amendments or modifications reflecting any reformulations to the packaging or packaging component.
- Must be available to any member of the public who requests the certificate.
Important!
Individual states may modify compliance requirements as per their individual statutes, it is important to check with the state concerned when attempting to comply with state regulations.
PVC Tech Corp and Toxics in Packaging
PVC Tech Corp offers a variety of materials currently certified to EN71-3, the European standard specification for migration of elements such as antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium.
These materials are specially produced to comply within the limits specified under EN71-3. If CONEG certification is a concern for you, please inquire about our EN71-3 qualified materials. Our certifications are traceable to our manufacturers who provide compliance documents as requested.
CPSIA (Consumer Product Safety Improvement Act) ¡V HR4040
The Consumer Product Safety Improvement Act (CPSIA) was written to improve the current statute of the Consumer Product Safety Act. It was enacted ¡§to establish consumer product safety standards and other safety requirements for children¡¦s products and to reauthorize and modernize the Consumer Product Safety Commission.¡¨
This is a landmark regulation that covers many children¡¦s products from books to clothing to toys and everyday items manufactured and marketed for children¡¦s use.
Under the CPSIA, the films we produce targeted for later use in the manufacture of children¡¦s products have been subject to the following requirements:
1. Lead In Substrate Compliance
The CPSIA introduces the following limits for lead in substrate:
| August 14, 2009: |
Limits Total Lead Content to 300ppm
General Certificate of Conformity and Accredited
Third Party Test will not be required till Feb. 10, 2010 |
| August 14, 2011: |
Limits Total Lead Content to 100 ppm
(if technologically feasible)
General Certificate of Conformity and Accredited
Third Party Test required at that time. |
| Test Method: |
CPSC-CH-E1002-08
Standard Operating Procedure for determining Total Lead in Non-Metal Children¡¦s Products.
http://www.cpsc.gov/ABOUT/Cpsia/CPSC-CH-E1002-08.pdf | |
2. Phthalates Compliance
The following phthalate limits are applicable to plasticized component parts of a children¡¦s product or article as defined by the CPSIA:
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CPSIA (HR 4040) GROUP 1 |
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BBP (Benzyl Butyl Phthalate)
DBP (Dibutyl Phthalate)
DEHP (Di-(2-ethylhexyl) Phthalate) |
Banned in ALL toys and childcare articles
For children up to 12 Years of age
Limit set of 0.1% concentration per phthalate per plasticized component of each product.
Permanent Ban |
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CPSIA (HR 4040) GROUP 2 |
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DIDP (Diisodecyl Phthalate)
DINP (Diisononyl Phthalate)
DnOP (Di-n-octyl Phthalate) |
Banned from use in ALL toys and childcare articles intended for children under three (3) yrs of age that can be put in children¡¦s mouths
Limit set of 0.1% concentration per phthalate per plasticized component of each product.
Interim Ban |
What are phthalates anyway?
Phthalates are esters of phthalic acid primarily used as plasticizers. It is most commonly added to soften Polyvinyl Chloride (PVC) polymer though its use is not limited to this.
Do ALL plastics contain phthalates?
No, they do not. Phthalates are more commonly found in flexible PVC products signified by the SPI marking below.
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PVC
Some Type 3 Plastics may leach Bisphenol A | *The Society of Plastics Industry (SPI) marking is used to identify a product for recycling and does NOT indicate product bearing this mark automatically contain phthalates.
Rigid plastics do not normally contain phthalates.
PVC Tech Corp and the CPSIA
No, we don¡¦t make toys or children¡¦s products, but our films are often used as components of final products manufactured and marketed for children.
We carry a range of CPSIA compliant flexible materials complete with the required accredited third party test reports certifying test results to both lead in substrate and phthalate restrictions under this regulation.
Though the Consumer Product Safety Commission (CPSC) has granted a one year Stay of Enforcement which alleviates the need to furnish general conformity certificates and the third party test reports until February 10, 2010, PVC Tech has chosen to provide these tests on all our phthalate-free materials prior to this date to give our customers peace of mind and the assurance that our films are safe to use for child product applications regulated by the CPSIA.
All tests are furnished by CPSIA accredited labs only and available upon request.
PROPOSITION 65 of California
Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986 or Prop 65 was a voter initiative passed into law to address public concern over exposure to unsafe and toxic chemicals in the State of California.
Proposition 65 states the following:
- Prohibition on Water Contamination
"No person in the course of doing business shall knowingly discharge or release a chemical known to the state to cause cancer or reproductive toxicity into water or onto or into land where such chemical passes or probably will pass into any source of drinking water, notwithstanding any other provision or authorization of law except as provided by Section 25249.9."
- Requirement of a Clear and Reasonable Warning Prior to Exposure
"No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided by Section 25249.10"
So what does that mean?
It means two main things.
One is that we have to be sure that in conducting our business no restricted chemicals noted in the Proposition 65 Chemical List are intentionally released to any sources of drinking water. This extends to requesting our manufacturers for certification to assure that the content of our films comply with Prop 65.
And two, that we post physical warnings that legibly and reasonably forewarn individuals within the vicinity of any potential exposure to any restricted chemicals on the Prop 65 list.
It's confusing, PROP 65 seems to have TWO different lists of Chemicals which do I use?
Yes, there are two lists released by Prop 65 for reference as follows:
- The Prop 65 Chemical List which lists approximately 750 chemicals known to cause cancer and birth defects of reproductive toxicity. This list does not specify concentration levels and encompasses the Safe Harbor List.
- The Prop 65 Safe Harbor Level List is a list of approximately 250 chemicals and their corresponding Safe Harbor Numbers. The safe harbor number indicates the exposure level per day which if exceeded would automatically require a Prop 65 warning.
Note: Recently, the OEHHA introduced a consolidated reference version incorporating the two lists into one for reference only. The Chemical List and the Safe Harbor List are still maintained separately. ( access via http://www.oehha.org/prop65/prop65_list/Newlist.html ).
The goal is to eventually have the entire Chemical List designated with safe harbor numbers but until that time, the Prop 65 Chemical List must be referenced when determining if any of the chemicals present in a product or the working environment falls under the Prop 65 requirements.
PVC Tech Corp and PROP 65
As a California business PVC Tech Corp complies with the requirements of Prop 65 and provide any available certifications traceable to our manufacturers for our films.
REACH
Registration, Evaluation, Authorization and Restriction of Chemicals
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a European Union Regulation (EC/2006/1907) which addresses the production and use of chemical substances in the European Union.
REACH covers ALL chemical substances in the EU, “whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations or in articles” with certain listed exceptions. In our case, our material would be considered an “article”.
The goal of REACH is to safeguard human health and environment from the risk of chemicals and to enhance the competitiveness of the EU Chemicals industry through research and innovation.
If your material or products are for eventual distribution to the EU market, you will be required to comply with REACH.
PVC Tech Corp and REACH.
Under REACH, the ECHA (European Chemicals Agency) publishes a Candidate List of Substances if Very High Concern (SVHC). Chemicals included in this list are substances which have been found to be carcinogenic, mutagenic, bioaccumulative and/or toxic.
In essence, these are chemicals known to have adverse effects on humans or the environment at a level of very high concern. The Candidate List is updated as chemicals are added or removed.
For US companies supplying articles to EU markets, REACH requirements may vary depending on the quantity (in terms of tonnage) of those products and whether or not the article “contain any Substance of Very High Concern GREATER than 0.1% weight per weight” (based on the weight of the entire article).
Since our films are used as components to manufacture final articles, we provide certification explicitly stating compliance to the limits set by REACH based on the ECHA Candidate List.
RoHS
Restriction of Hazardous Substances
RoHS (Restriction of Hazardous Substances) is a European Directive (2002/95/EC) which restricts the use of specific heavy metals and flame retardants in electrical and electronic equipment.
The RoHS restrictions are as follows:
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Heavy Metals
Lead
Mercury
Cadmium
Hexavalent Chromium |
Flame Retardants
PBB Polybrominated Biphenyls
PBDE Polybrominated Diphenyl
Ether |
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Limits for all Heavy Metals & Flame Retardants EXCEPT Cadmium:
Maximum Permitted Concentration of 0.1% or 1000 ppm (parts per Million) by weight of Homogenous Material |
Limits for Cadmium:
Maximum Permitted Concentration of 0.01% or 100 ppm (parts per Million) by weight of Homogenous Material |
What is ppm (parts per million)?
Denotes the amount of a given substance in a total amount of 1,000,000 regardless of the units of measure used as long as they are the same. E.g. 1 milligram per kilogram. 1 part in 106.
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What does “Homogenous material” mean?
Homogenous material refers to any single substance that could NOT (theoretically) be separated mechanically and is “of uniform composition throughout.” Examples aside from plastics would be ceramics, glass, metals, alloys, paper, board, resins and coatings.
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But you sell PVC and polymer films, not electronics
Correct. But our films often find their way into parts used to build electronics and is considered a homogenous material.
Is RoHS and REACH the same thing?
No, they’re not, though both are European directives.
REACH restricts chemicals and substances beyond those identified under RoHS and is far broader in scope. RoHS requirements are specific to homogenous materials used in electronics and electrical parts, while REACH is not use-specific.
PVC Tech Corp and RoHS
We offer a variety of materials compliant to the EU RoHS with certifications traceable to our manufacturers.
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