2002-10

BPD Timetable and Industry Opinion.

Chemical Week: September 2002

Suppliers of biocides are coming to terms with the European Commission’s Biocidal Products Directive (BPD), which stipulates that they must register biocides they intend to continue producing, or plan to withdraw unregistered products. Most of the large producers say the BPD is a positive development. They say it will regulate the industry, harmonize national biocide legislation already in place in several of the European Union member states, and will bring the industry in line with requirements in the U.S.

Many smaller players, however, say that the BPD is too complex, time-consuming and far too expensive for them. Costs of testing are estimated at up to  Euro 5 million ($5 million) for each active substance and application; the actual amount depends on how much data companies already have.

“There will probably be quite a few products pulled off the shelves as a results of the BPD, but we don’t yet know which and how many”, says Michel Michaux, manager /product stewardship at Cefic. No products have been withdrawn from the market so far, however, Michaux says. “Cefic considers BPD too complex for the benefit that the environment and public health would gain”, he says. “We would have preferred the BPD to be considerably simplified”.

BASF says the “extremely high” cost of testing will force some products off the market. “Some substances cannot be commercially justified” in light of the costs, says Clive Aveyard, regulatory affairs manager at BASF Biocides (Nottingham, U.K.). Clariant, says, that it will discontinue manufacturing some phenolic formulations, sold as low cost disinfectant actives, because of the high cost of testing. “It is not a significant part of our business, and the market size would not justify us continuing to promote these products,” says Michael Parkin, global marketing manager/biocides at Clariant..

Lonza says it will also discontinue the manufacture of some biocides. “There are a couple of products serving the industrial institutional hygiene market that we will not support because the business does not justify it,” says Gary Williams, head of performance chemicals at Lonza.

Avecia, meanwhile, considered but did not pursue regulatory compliance steps for three activities, also citing registration costs. “Registration costs versus sales would have rendered these activities commercially nonviable,” the company says.

Safeguarding intellectual property is another concern. “We hope that the European authorities will respond to the biocide industry’s request for data protection to justify the costs of data support,” Parkin says. There are a lot of detailed discussions on this subject in Brussels at the moment, he says. “The practical implementation of data protection is something with a lot of pending questions and all the producers are worried about this,” Michaux says.

The commission received notification covering just 350 active substances, about one third of the total available on the market by the original deadline, Michaux says. Several suppliers whose products overlap have formed consortia or are in discussion to link up to share the costs of testing. “Lonza is participating in four data consortia with other companies in support of the BPD,” Williams says. He declines to be more specific but says that the consortia are “organized around a family of products.”

BASF plans to jointly test with other producers “where possible”, Aveyard says. Clariant is also in discussions with other producers to jointly test overlapping products, but says this is unlikely to happen in the immediate future. “I would anticipate real co-operation starting only in the next 24 months, as the testing for a full dossier is initiated”, Parkin says. The following is a summary of the BPD timetable:

 

BPD TIMETABLE

March 2001

Companies must notify regulators on actives they want to continue manufacturing. Deadline extended to January 31, 2003

March 2004

Priority product group – wood preservative and rodenticides- must provide full data dossier to authorities

May 2006

Next product group must have data submitted – most likely molluscicides, insecticides, repellents, antifouling agents

August 2007

Human hygiene biocidal products data submission

November 2008

Film preservatives, masonry preservatives, slimicides data submission

2010

BPD fully in force

 

BEING RESPONSIBLE. Producers say the BPD is good for society, despite the problems it poses. “Product stewardship and the safety of the use of biocides is very important for society, and companies need to be more rigorous and more responsible about how these chemicals might interact in the environment,” Williams says.

The new regulation is a lot of work, but it is good for the industry, says Jeremy Scudamore, CEO of Avecia. “It will get some regulation and sense into what is quite a diverse industry, and will get rid of some operators who are offering substandard products and in adequate product stewardship,” Scudamore says.

Methyldibromo Glutaronitrile to be restricted in EU.

European Chemical News: September 2002

The European Commission's Scientific Committee on Cosmetic products and non Food products has recommended that methyldibromo glutaronitrile, a preservative used in personal care products, should only be used at the maximum permitted level of 0.1 % in products that are washed off the body such as shampoo. The product should not be used at those levels in sun creams and moisturizers that are left on the body, “until appropriate and adequate information is available,” the committee says. The recommendation follows a rise in allergic skin reactions, including rashes, swelling and itching, reported during the last two to three years, following increased use of the product, the committee adds. The advice has been passed onto European Union member governments to decide individually which course of action to take. Makes of the product include BioChema Schwaben (Memmingen, Germany).

growth in this business has been limited or nonexistent in many segment in the last three years.”

Engelhard's Antimicrobial gets new EPA Registration.

Specialty Chemicals: September 2002

The U.S. Environmental Protection Agency registered Englehard Corp.'s Aseptrol antimicrobial tablets for use in water- purification applications. The chemical company said Aseptrol's patented technology -- which can be tailored to release germ-killing chlorine dioxide at precise rates and in controlled concentrations when the powder or tablet comes in contact with water or moisture in the air -- creates a wide range of potential new uses for the biocide. Engelhard said Aseptrol chlorine dioxide is also effective against cryptosporidium.

Currently, the product is used as a deodorizer in breath fresheners, smoke- and water-damaged buildings and shoes. It is also used to control mold in swimming pools and the desliming of ice machines and water softeners. A company spokesman said the Aseptrol technology is too new to provide data on current and projected sales of the product.

Bioshield changes Name to International Biochemical Industries.

Chemical Marketing Reporter: September 2002

BioShield Technologies has changed its corporate name from BioShield Technologies, Inc. to International BioChemical Industries, Inc. (IBC Industries). The corporate name change is being made to help promote the new direction of the company and reposition the company to better describe our business focus and model.

Deirdre Baker, IBC Industries General Manager, stated, "This new corporate name change hinges on a multitude of achievements that we've made as a company during the past few months and helps us put forth the international focus and our broad product line, under the BioShield trademark, in the biochemical industry. 

International BioChemical Industries, Inc. is a Norcross, Georgia-based emerging growth company focused in biotechnology and antimicrobial products. Its core business is committed to the discovery, development, marketing and sale of surface-modifying antimicrobial and biostatic products. The company announced sales increased to $1,937,122 for fiscal year 2002 as compared to $1,500,648 for fiscal year 2001.

Lonza acquires Biocide Technology.

Chemical Week: September 2002

Lonza says it has acquired exclusive distribution rights to a biocide technology for personal care, wood protection, household, industrial and institutional applications from Intelligent Biocides (Tyngsborough, MA) The technology, Surfacine, is a persistent, silver based antimicrobial that can be used on skin and many other surfaces, Lonza says. Terms of the deal were not disclosed. The first formulations are now being developed.