2015-05

BIOCIDE PRECURSOR SUPPLIERS MUST NOTIFY ECHA

 ECHA Release: May 2015

Companies must notify Echa, within a year, if they intend to support precursors for certain in situ-generated biocides that are at present not part of the biocidal products review programme.

The notification procedure was set up, following recent agreement by the competent authorities on how in situ-generated biocides should be handled. The European Commission, which published a document on the agreed approach, says it is important for all companies selling precursors for in situ systems, and users of such systems or manufactures of devices, to check if they need to take any action.

Biocidal active substances are called 'in situ generated' if they are generated from another substance (a 'precursor') at the place of use. Until now, active substance evaluation has not consistently covered both the precursors and the generated active substance. To improve consistency in the evaluation, potential risks of both the precursor(s) and the substance it generates will now be evaluated.

To take this change into account, the in situ generated active substances have been redefined to consistently refer to both the substance generated in situ and its precursors presently included in the review programme. This may lead to situations where other precursors that are used by industry are not covered by the review programme. Therefore companies using other precursors are invited to notify ECHA within one year if they wish to have their precursor-active substance system also included in the review programme

Meanwhile, Echa has announced that the latest version of the information submission portal, R4BP, has been launched. The new version, 3.2.2, allows companies to make product authorisation change requests in parallel – which could be useful, for example, to change product classifications to meet the 1 June CLP deadline. It also enhances synchronisation between related applications, says the agency

DOW SIGNS UP TO THE BLUSIGN SYSTEM

 Press Release: May 2015

Dow Microbial Control has officially joined the bluesign® system, a network of leading companies serving textile and apparel markets around the world. Chemical manufacturers who are partners in the bluesign system, which also includes textile and apparel manufacturers and brands, agree to improve performance in five areas of their production processes: air emissions, consumer safety, occupational health and safety, resource productivity and water emissions.

Dow Microbial Control introduced SILVADUR™ Antimicrobial, a cutting-edge microbial control product for textiles and apparel, in September 2012. Since its introduction, SILVADUR has gained widespread recognition in global markets, because it provides reliable, long-lasting freshness in textiles and apparel at a time when more and more consumers are embracing a healthier, more hygienic lifestyle.

"Dow is dedicated to helping lead the transition to a sustainable society and planet," said Karel Williams, global strategic marketing associate director for Dow Microbial Control. "Joining the bluesign system is an important step we are taking to assure textile and apparel manufacturers and brands, their customers and others that products treated with SILVADUR do not compromise human health or harm the environment."

The bluesign system is managed by Swiss-based bluesign technologies ag, which works with the supply chain to ensure that textile and apparel products, and the chemicals, processes and materials used to make them, are safe for consumers, workers and the environment. Among its roles are to regularly review progress reports from chemical manufacturers who are partners in the System and to conduct on-site audits of their production facilities.

SILVADUR's patented Intelligent Freshness technology provides reliable odor control in textile and apparel products. When odor-causing bacteria land on the surface of treated fabrics, they are neutralized on contact by SILVADUR's invisible freshness protection ingredient, so treated fabrics stay fresher longer. Extensive testing has shown that SILVADUR Antimicrobial has a high degree of efficacy against a wide range of undesirable bacteria, is highly durable over 50 washings and its application process is efficient and cost effective.

FDA LOOKING FOR MORE DATA ON HAND CLEANERS

 European Cleaning Journal: May 2015

The US government is calling for more data on medical hand washes and hand sanitisers to ascertain their long-term effects when used daily. The Food and Drug Administration says more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, GP practices and nursing homes.

The FDA wants manufacturers to provide information on the possible hormonal effects of the products as well as their contributions to antibiotic-resistant bacteria.

Antiseptic ingredients such as alcohol and iodine have been used by medical staff for decades. But regulators are concerned at emerging science that suggests antiseptics are absorbed into the body at higher levels than previously thought, showing up in the blood and urine of users. The FDA will also seek information about possible links between the use of antiseptics and the growth of antibiotic-resistant bacteria.

Professional guidelines currently urge medical personnel to sanitise their hands before and after visiting each patient's room. But FDA scientists say their routine use has increased over the last 20 years as healthcare staff work harder to combat hospital infections.

"We're not asking for any of these products to come off the market at this time; we're just asking for additional data," said FDA drug agency director Theresa Michele. "And we're likewise not suggesting that people stop using these products. But 20 years ago you didn't find people using antiseptic gels 100 times a day; it just didn't happen." Products that are not shown to be safe and effective by 2018 would have to be reformulated or removed from the market, claims the FDA."

GUIDANCE / REVIEWS TOP COMMISIONS AGENDA FOR BIOCIDES

 Chemical Watch: May 2015

The Commission says it is "almost there" in finalising the guidance documents and implementing legislation it plans to publish under the biocidal products Regulation (BPR), said Ludovic Chatelain of its biocides team. Next up for adoption at the next meeting of the biocides competent authorities is guidance on comparative assessment, and on biocidal product families.

His team is also trying to ensure that Echa's Biocidal Products Committee can meet the ambitious goal of finalising 50 opinions on active substance/product-type combinations per year. The agency expects to publish 57 opinions, this year, having already agreed 18. It will then try to produce a steady 50 each year.

The objective, he said, is to finish reviewing the 620 dossiers, supported under the biocides review programme, by the end of 2024. The authorities are on track to achieve this, Mr Chatelain said, and, so far, Echa and the Commission have taken decisions on 20% of them.

Echa, meanwhile, is working on updating its new list of pending Article 95 applications. The document, published last month, lists applicants who submitted applications that are still being processed by the agency.

Other priorities for the Commission's biocides team, said Mr Chatelain, are to:

(1) clarify the management of nanomaterials, and in situ generated active substances.

(2) finalise further guidance on masterbatches; and

(3) clarify the setting of maximum residue limits for biocides used in the food industry.

EPA ANNOUNCES REGISTRATION OF NANOSILVER

 Press Release: Environmental Agency May 2015

EPA has issued a registration for a nanosilver-containing antimicrobial pesticide product named "NSPW-L30SS," or "Nanosilva." This silver-based product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold and mildew. Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories. EPA's decision was based on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature. These data show that plastics and textiles treated with NSPW-L30SS release exceedingly small amounts of silver. Based on this evaluation, the Agency determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products. EPA is also requiring the company to generate additional data to refine the Agency's exposure estimates.