The U.S. Food and Drug Administration is in the middle of a lengthy review of the chemical triclosan — a product that’s in countless consumer products like toothpaste and soap. There’s a movement to try and get the product more stringently regulated in the United States — or banned outright. And they might have just gotten a boost from Canada.

Triclosan has been around for 40 years. For nearly all that time U.S. officials have been investigating the chemical’s safety and effectiveness. Now the Canadian government has just declared the antibacterial agent an environmental toxin, and has proposed regulations to curtail its use in Canada.

The FDA review is supposed to be completed by winter 2012.

For more information see the above link.

The European Chemicals Agency (ECHA) has published an updated version of the Guidance on the Application of the CLP Criteria following the conclusion of the consultation process. In parallel, ECHA has released a report on a workshop concerning the validity of the concept of “rapid removal” for aquatic environmental long-term hazard classification of metals and inorganic metal compounds.

For more information and to download the updated guidance document please see the above link.

In their quest to rid cleaning products of toxic chemicals, consumer advocates have now set their sights on Tide, the best-selling laundry detergent.

Last fall, the environmental groupWomen’s Voices for the Earth commissioned laboratory tests on 20 cleaning products and found what it described as problematic levels of 1,4 dioxane, a solvent, in Tide Free & Gentle (fragrance free) and Tide Original Scent, said Erin Switalksi, the group’s executive director. Smaller amounts of the chemical were found in Bounce Free & Sensitive (fragrance free), dryer sheets that are used to reduce static.

Small amounts of 1,4 dioxane are formed during the manufacturer of detergents, shampoos and certain drugs. The Environmental Protection Agency considers the chemical a probable carcinogen.

Ms. Switalski said her group had relayed its concerns to Procter & Gamble, the manufacturer, and that a group of advocacy organizations had done so as well, demanding action. “Tide Free and Gentle is marketed to moms as a healthier choice for babies,” she said, adding, “Our perspective is that it doesn’t need to be in there.”

But Procter & Gamble officials say that the levels of 1,4 dioxane in their products are minuscule and well within generally accepted safety guidelines. “We are many, many levels of magnitude below the levels that are considered any level of safety risk,” said Tim Long, a toxicologist for the company.

Procter & Gamble does not plan to reformulate the products based on the recent testing. However, Mr. Long said the company has been working for decades to reduce or eliminate even trace elements of 1,4 dioxane and other toxic chemicals in its products and continue to do so.

One difficulty is that the federal government has not published a definite limit for what constitutes a safe level of 1,4 dioxane in consumer products. In March, the Environmental Protection Agency identified 83 chemicals for further assessment under the Toxic Substances Control Act, and 1,4 dioxane was on the list.

In addition, the E.P.A. allows no more than 100 parts per million of 1,4 dioxane for a product to be eligible for its Design for the Environmentprogram, a labeling program intended to highlight safe cleaning and household programs.

The Women’s Voices for the Earth’s lab testing found 89 parts per million of 1,4 dioxane in Tide Free & Gentle, 63 parts per million in Tide Original Scent and less than 1 part per million in the Bounce product, Ms. Switalksi said.

Procter & Gamble official said the amounts were so low that they had not warranted the government’s full attention. They pointed out, for instance, that while the Food and Drug Administration has not set a limit for 1,4 dioxane, it considers current levels in cosmetics are permissible.

But Ms. Switalski said the uncertainty underscores why Procter & Gamble should remove the chemical from its products. “We don’t fully understand how much 1,4 dioxane is needed to give someone cancer,” she said, arguing that the levels might be different for infants and people who are sick. “For us, the bottom line is that Tide and Tide Free and Gentle are contaminated products.”

In the last several years, independent laboratory tests have become a common tool for consumer groups seeking to pressure the companies to reformulate consumer products.

In 2010, Procter & Gamble reformulated its Herbal Essence line of shampoos so that they carried no more than 10 parts per million of 1,4 dioxane, which company official said was part of an overall effort to reduce or eliminate the chemical from its products.

And last year, Johnson & Johnson said it was reformulating its baby productsto remove phthalates and to reduce 1,4-dioxane in baby shampoos.

We will keep you updated of any regulatory changes.

The ECEAE has launched a new initiative with concerned companies across the industry, with the goal to gain acceptance in China for the well-established and validated methods that are available as an alternative to cosmetics testing on animals. We have invited companies to join this campaign whether or not they are already certified under the Humane Cosmetics Standard, so that we can get the broadest possible support for our objective to persuade the Chinese government to remove this barrier to ethical trade.

Both animal protection campaigners and the cosmetics industry are very concerned about the absence of alternatives to animal testing for cosmetics in China, as well as the requirement to do additional testing even for products already tested elsewhere. This puts industry in a difficult position, since many products have been long accepted around the world and companies are reluctant to see further animal testing take place when the products are already known to be safe. However, reports suggest that China is now planning to open the possibility of non-animal alternatives.

In March, at an inaugural meeting at the BUAV offices in London, representatives of leading cosmetics companies met with representatives from the BUAV and the ECEAE to discuss how progress could be made, with the support of the European Commission and Cosmetics Europe in finding a way forward that would meet the concerns of all sides. The productive meeting reached agreement on a number of ways to pursue the issue in partnership and it is hoped to have significant progress to report later this year.

For more information click here.

The US EPA has published 19 premanufacture notices (PMNs) and ten notices of commencement (NOCs) for new chemicals. Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Chemical Substances Inventory (TSCA Inventory)) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish in the Federal Register a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME), and to publish in the Federal Register periodic status reports on the new chemicals under review and the receipt of notices of commencement (NOC) to manufacture those chemicals. This document, which covers the period from February 20, 2012 to February 29, 2012, and provides the required notice and status report, consists of the PMNs pending or expired, and the NOC to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

For more information click here.

An order deleting 11 substances from part I of the Non-domestic Substances List under the Canadian Environmental Protection Act has been published by Canada’s Minister of the Environment in the Canada Gazette.

The order also removes aceto(2-carboxyphenyl)(2-methoxyphenyl)oxotriazaalkene from part II of the list.

We will keep you informed on any further changes to the Non-domestic Substances List.

This recall involves “Quick Fix Tire Inflator” instant flat tire sealer and inflator. The product is sold in a 340-g aerosol container and can be identified by the UPC 790920127610.

An inspection by Health Canada has determined that the recalled product does not meet the hazard symbols and bilingual labelling requirements for consumer chemical products under Canadian law.

This lack of labelling information could lead to improper handling and use of the product and to serious injury.

Neither Les Pièces d’auto Transit Inc. nor Health Canada have received any reports of incidents or injuries related to the use of this product in Canada.

Consumers should immediately stop using the recalled product and dispose of it as per Municipal Hazardous Waste Guidelines.

For more information, consumers may contact Les Pièces d’auto Transit Inc. at1 800-263-8916.

The National Council of Churches expressed disappointment in the Food and Drug Administration’s conclusion that there is insufficient evidence to ban bisphenol-a (BPA), a chemical found in many aluminum cans and some infant formula containers.

The chemical is linked to health concerns in numerous studies that identify such problems as early puberty in girls, prostate and breast cancer, obesity and type II diabetes, heart disease, infertility and neurological issues.

“The faith community is clear on the need to care for the health of our neighbors and to prevent suffering,” said Chloe Schwabe,Environmental Health Program Manager for the NCC’s EcoJustice programs.

“With a scientific body of evidence that continues to produce studies showing harm, we believe the F.D.A. made the wrong decision to allow BPA, a chemical linked to prevalent health conditions, to remain in aluminum cans and infant formula.” Schwabe said.

The full statement is below:

The Food and Drug Administration’s (FDA) decision to allow bisphenol-a (BPA) to continue to be used in baby bottles, sippy cups, infant formula cans, and food cans in the face of numerous studies that link BPA exposures at low-doses to prevalent health concerns such as cancer, early puberty in girls, and type II diabetes is a violation of our call as Christians to protect the health of God’s children, low-income communities, and all life on Earth.

In the hard economic times, more families prepare meals with canned food and a recent study from Boston University School of Public Health used data from the National Institute of Health and found that low-income communities who receive emergency food assistance have higher levels of BPA in their bodies. People living in poverty should not be unduly exposed to BPA or any chemical with mounting evidence of harm to people and God’s Creation.

As 11 states, Canada, France, Denmark, China, Taiwan, Malaysia, the United Arab Emirates, and the EU Commission pass stringent restrictions on this chemical, and the chemical industry and product manufacturers move forward to replace BPA in baby bottles, sippy cups, and aluminum cans, the FDA falls short of guaranteeing a healthy future for all God’s children in the United States.”

We will keep you updated regarding ongoing changes to BPA regulations.

The completion this week of an €830m acquisition by Russia’s Eurochem of the Dutch fertiliser operations of BASF, the German chemicals combine, highlights the growing interest of EM companies in buying assets in the developed world.

Even though it coincides with developed-world chemicals groups making acquisitions in EMs, there is a clear logic to these deals: access to technology and markets and the establishment of closer links with developed-world regulators. As Fitch, the credit ratings agency, says, there are more such transactions in the pipeline.

Fitch said in a note on Wednesday it saw “chemical assets in mature markets attracting increasing interest from emerging market (EM) producers, mirroring Western European producers’ ongoing expansion drive into high growth markets.”

Myriam Affri, a director in Fitch’s industrial team, told beyondbrics: “Emerging-market companies are moving downstream and looking to increase their technological content. we are going to see an acceleration in the move towards international markets.”

Recent acquisitions follow on the heels of many joint ventures, for example those involving China’s Sinochem and Sinopec, and Indian state-run enterprises such as the Indian Farmers Fertilizer Cooperative and Southern Petro-chemicals Industries Corporation.

As the Eurochem deal shows, Russian fertiliser companies are looking abroad after a period of intense consolidation at home which saw the creation of big groups, headed by Uralkali.

Eurochem is controlled by billionaire Andrei Melnichenko who also owns almost 10 per cent of K+S, a German salt and fertiliser producer and former BASF subsidiary.

Fitch lists other important deals and near-deals headed by the failed $12bn bid in 2009 by India’s Reliance Industries for Dutch-based LlyondellBasell (2009).

Successful transactions include Abu Dhabi-based International Petroleum Investment Company’s $2.3bn acquisition of US-based Nova Chemicals Corporation in 2009;  China Bluestar Group’s $2.2bn acquisition of Norway’s Elkem (2011); and Thailand-based Indorama’s $795m acquisition of US-based Old World Industries (2012).

Sinochem last year withdrew a $2.3bn bid for Australia’s Nufarm.

Fitch says leading EM chemicals producers are hungry for international action as they complete costly multi-year domestic investment programmes.

More information can be found here.

]]> http://www.nexreg.com/regulatorynews/index.php/2012/04/12/april-12-eu-eu-chemicals-the-russians-are-coming/feed/ 0 http://www.nexreg.com/regulatorynews/index.php/2012/04/11/april-11-us-new-study-warns-against-%e2%80%98reforming%e2%80%99-toxic-substances-act/ http://www.nexreg.com/regulatorynews/index.php/2012/04/11/april-11-us-new-study-warns-against-%e2%80%98reforming%e2%80%99-toxic-substances-act/#comments Wed, 11 Apr 2012 12:00:52 +0000 Nexreg Compliance http://www.nexreg.com/regulatorynews/?p=1943 From Heartland.org:

Efforts to reform the Toxic Substances Control Act could end up harming human health by stifling innovation and keeping perfectly safe and beneficial products from reaching consumers, concludes a just-released study by the Competitive Enterprise Institute.

Changes Would Stifle Innovation

“Changes to TSCA are highly unlikely to have any measurable positive effect on public health, given the scant evidence that the trace-level substances that TSCA regulates have any significant health impacts,” said Angela Logomasini, director of risk studies at CEI, in a press release accompanying the study.“Rather, a stronger TSCA law may harm human well-being by leading to bans on many valuable products, undermining innovation, and diverting resources from valuable enterprises to meet burdensome regulatory mandates.”

TCSA Balances Costs, Benefits

Enacted in 1976, TSCA is designed to regulate chemicals not covered by other environmental statutes. TSCA also differs from other environmental laws in setting a risk-based standard for allowing the U.S. Environmental Protection Agency (EPA) to regulate chemicals.

TSCA “also demands that the agency consider both cost-benefit considerations and potentially adverse outcomes of its regulatory actions,” noted Logomasini. “Under TSCA, EPA is allowed to regulate when the agency finds that a chemical poses ‘an unreasonable risk to health or the environment.’ Once that determination has been made, EPA must apply such restrictions ‘to the extent necessary to protect adequately against such risk, using the least burdensome requirements.’”

Precise Language Drives Success

The CEI study, “The Real Meaning of TSCA ‘Modernization’: The Shift from Science-based Standards to Over-Precaution,” warns “reforming” TSCA may transform the law into the antithesis of what it was created to do.

Because TSCA has a risk-based approach to regulation, the carefully crafted language of TSCA has generally avoided creating controversies like those that have surrounded the Clean Air Act, Clean Water Act, and other more loosely worded laws. Weakening the statute’s scientific safeguards could bestow EPA with far-reaching discretionary power to regulate as it sees fit, the study warns, which will dramatically change the intended nature of the law.

“Contrary to many claims,” the study explains, “the EPA has managed to use [the TSCA] to impose thousands of regulations, collect substantial data under both mandatory and voluntary programs, and demand testing of chemicals.”

Activists Seek Presumption of Guilt

Ironically, it is the clear and carefully tailored language of the TSCA that has frustrated environmental activists and prompted them to pressure the Obama administration to call for “modernizing” the statute. Richard Dennison of the Environmental Defense Fund (EDF), for example, advocates a “presumed guilty until proven innocent” approach to a restructured TSCA.

On the legislative front, Sen. Frank Lautenberg (D-NJ) introduced a bill in 2009 to, in his words, “put the burden of chemical safety where it belongs: on the chemical companies.” Lautenberg’s bill was not enacted, but that hasn’t kept environmental activists from urging Congress to scrap TSCA’s current risk-based standard for a more speculative “precautionary” approach.

“Some would model the new rule after the ‘reasonable certainty of no harm’ standard set in the Food Quality Protection Act, which has produced a host of unnecessary bans and regulations on valuable products that are used to ensure affordable food production and control of dangerous pests,” Logomasini explained.

Where Is the Need?

“Where is the evidence that we, the people, need to be protected from environmental exposure to tiny amounts of chemicals?” asks Gilbert Ross, M.D., medical director of the New York-based American Council for Science and Health.

“The cries for ‘reform’ emanate from the same environmental activist groups that oppose so many other beneficial chemicals and technologies,” Ross continued. “These well-funded groups, whose raison d’etre is to foment regulation and litigation, say the law is creaking at age 36, and only a handful of chemicals have been regulated under its auspices. Talk about circular logic—the chemicals assessed have been found to be safe, so they say something must be wrong with the law!”

We will keep you informed about any changes to the TSCA.