Regulatory

Canada Environment D4, D5, D6 Update

Cyclic Silicones Q&A - FAQ

REACH

INCI, CAS, EINECS, and Japan info as related to Grant products.

The Canadian Challenge to Industry Program
Cyclomethicones D4, D5 and D6 - Update February '09

Our customers have inquired if there is a ban or possible use restrictions on cyclomethicones in Canada that would force them to reformulate some of Grant's products. Earlier in 2008, the Canadian Ministers of Environment and Health issued a challenge and a request for information from the silicone industry in response to their concerns about the environmental fate of D4 (cyclotetrasiloxane), D5 (cyclopentasiloxane) and D6 (cyclohexasiloxane), also known as cyclic silicones. The silicone industry supported this challenge and presented a large data set to support the human and environmental safety of these materials.

On January 30, 2009, the Ministers’ final screening assessments found that D4, D5 and D6 does not pose a risk to human health. This is very important news - one that confirms the safety of these materials as viewed from the perspective of a national governing body. It also supports something we have been saying here a very long time, these materials are perfectly safe for topical cosmetics.

The Minister of Environment also found that D6 does not pose a risk to the environment. In short, D6 will not be restricted in any way in Canada.

The Minister of Environment has recommended listing D4 and D5 as possibly warranting environmental regulatory measures. But, no action was taken based on this recommendation. If the recommendation is ultimately adopted, the Canadian Government will factor in the "soon to be completed" scientific studies further examining how the materials actually behave in the environment. We anticipate that these studies will continue to demonstrate that D4 and D5 are safe for the environment and that action will not be needed.

This is encouraging news - in that the Canadian government is allowing the scientific process to unfold so data are reviewed in context to the questions posed. Namely, is the level of these solvents accumulating and persistent in the environment? The original concern came from a data set primarily based on computer modeling experiments and not on environmental field results. One should question this model's predictions for relevance to silicones, since most envirochemical computer models were developed to screen the fate of hydrocarbon based molecules. The answer is only obtained with real world samples taken from many sources, both rural and urban. This takes time and money, both of which are being allocated in full.

We have heard on good authority that no restrictions will occur before 2011, if they are to occur at all depending on actual field study results. If action is taken in the future on D4 and D5, note that current language is centered on restrictions and not the banning of these materials. This means our industry would have to comply with certain environment release restrictions via manufacturing waste water reduction (which frankly should always be done within our industry!)and possibly restricting the use level in finished products. This whole situation is similar to Califonia's VOC restrictions in the 90's. Beyond the earlier banned CFC's, no one was forced to stop using traditional VOC's, for example SDA-40 (alcohol). What actually occurred was the amount was reduced to 80% and then later to 55% in hairsprays. These may entail some formula rebalancing, but not a total replacement of the alcohol.

To our formulator and marketing friends: we recommend not reformulating out D5 solely based on this challenge. It is safe, cost effective and frankly a great material. For those wanting to reformulate, consider that D6 is not under any pressure, so please don't lump everything into one neat "cyclic" package. For those of differing viewpoints, we respect that and we provide a nearly unlimited variety of cyclic-free options in all areas of our product line.

Conclusion: We continue to support D5 because we base our entire business on science, technology and compliance with regulations. Currently, outside of D4 in the EU there are no restriction for these cyclics, and there may not be any in the future beyond some level restrictions that we can all comply with if so challenged.

D6: Favorably passed the challenge on both human and environmental health. No restrictions to our industry!
D5: Testing is continuing until about 2011 and we will post and news on this (good or bad) in a forthright manner when possible. In the meantime. There are no restrictions on D5 use, outside of maintaining a low D4 level of <1% to allow every possible use the EU.
D4: Generally no restrictions, except in the EU where 1% use level is permitted.

The unwavering support and open sharing of data from our industry has only solidified the safety profile of these materials, not hindered it.

The statement and Q&A below is from the Silicones Environmental, Health and Safety Council of North America in response to this challenge. At this time it is our position that there is no reason to initiate reformulating products as the silicones industry is providing proper scientific data to support continued unrestricted use for cosmetics and beyond.

We support both the environmental and health safety of the materials we provide to our customers and the right of a governmental body to request information about such materials. However, we urge our industry partners to read the following information and make informed decisions regarding the applicability, self-regulation and safety profile of silicones in general.
Thank you for your continued support!

John Gormley
Director of Regulatory Affairs
Grant Industries Inc.

For more information on silicone manufacturers’ activities to address this initiative, go to www.sehsc.com, or contact—
Karluss Thomas
Executive Director
Silicones Environmental, Health and Safety Council of North America
2325 Dulles Corner Boulevard, Suite 500
Herndon, VA 20171
Phone: (703) 788-6570
Email: Kthomas@sehsc.com
www.sehsc.com

Silicones Environmental, Health and Safety Council link with updated info
http://www.sehsc.com/

Cyclic Silicone Q&A -FAQ's

What are D4, D5 and D6?

D4, D5 and D6 are part of a family of chemical building blocks that are variations of the natural element silicon. These three silicones are used primarily to make other silicones. These extensively studied materials are an important part of many of the products we use and enjoy every day.

What types of consumer products are made with these materials?

D4 and D5 are ingredients in a wide variety of consumer products, including personal care and household cleaning products. For example, shampoos and hair conditioners, moisturizers and lotions, bath gels and soaps, and antiperspirants and deodorants apply more smoothly, feel more luxuriant, produce better shine and don't sting or stain, as a result of silicones. Laundry detergents, fabric softeners, and kitchen and bathroom cleansers are gentle, effective and aesthetically appealing because of silicones. Consumers have safely enjoyed the benefits of products made with these materials for 50 years.

Are personal care or household cleaning products made with D4 and D5 safe for everyday use?

Yes. These materials are some of the most studied in the world. Extensive research and decades of real world use ensures consumers that D4 and D5, as they are commonly used in consumer products, are safe when used in accordance with accepted health and safety principles.

Should I be concerned about exposure to these materials?

No. More than 130 studies have been performed on the health and environmental impacts of D4, D5, and D6. The studies show that D4, D5, and D6 do not pose an undue risk to the environment and that they are safe for use in appropriate cosmetic, industrial, and consumer product applications when used in accordance with accepted health and safety principles. The Canadian Minister of Health has stated that D4 and D5 do not pose a risk to human health.

Are these materials found in the environment?

The levels at which these materials are found the environment will not impact human health, wildlife or the environment. To date, environmental monitoring studies confirm that these materials are found at low concentrations, particularly as you move away from urban areas. In places such as areas of Lake Ontario, levels are non-detectable. Ultimately, most of the D4 and D5 that enters the environment will evaporate or break down into some of earth’s most common components – sand, water, and carbon dioxide.We expect low concentrations of these materials in the environment, and at levels that will not impact human health, wildlife or the environment. Most of the D4, D5 and D6 that enters the environment will evaporate or ultimately break down into some of earth's most common components - sand, water, and carbon dioxide.

In January 2009 the Canadian Minister of Environment suggested these materials may potentially be harmful to the environment, why?

The Minister of Environment, as part of its ongoing Chemicals Management Plan, has conducted screening reviews for a number of materials and recommended listing D4 and D5 as possibly warranting regulatory measures. No action has been taken based on this recommendation. If the recommendation is adopted, the Canadian Government will factor in soon to be completed scientific studies further examining how the materials actually behave in the environment. 50 years of real life applications, supported by extensive laboratory study and environmental monitoring, demonstrate that these materials are safe for the environment and action is not needed.

What was the basis for the minister of Environment’s recommendation?

The Minister of Environment relied primarily on an assessment methodology that does not fully consider the ways these materials break down and behave in the environment. The available data indicate that D4 and D5 should not harm the environment at the levels found.

Can’t products be made without D4 or D5?

D4 and D5 have a unique chemistry that is part of what makes them such helpful ingredients for so many different kinds of consumer and industrial products. They enhance the quality, reliability and function of products in a variety of ways. They make final products stronger, more durable, more water repellant or water-absorbing.

Can't products be made without D4, D5 and D6?

D4, D5 and D6 have a unique chemistry that is part of what makes them such helpful ingredients for so many different kinds of consumer and industrial products. They enhance the quality, reliability and function of products in a variety of ways. They make final products stronger, more durable, and more water repellant or water-absorbing.

How do I find out if one of these ingredients is in a product I'm using?

Personal care and household products regulated by Health Canada carry varying label information. Common names include cyclotetrasiloxane (D4) and cyclopentasiloxane (D5). All personal care and household products must be labeled in accordance with Health Canada labeling requirements.

Where can I find more information about D4, D5 and D6?

For more information on the safe use and benefits of these materials, please go to www.sehsc.com.

The European silicone industry position:

25-Jun-2008 - The European trade body for silicones has hit back against claims that the chemical family is threatened in personal care by alternatives and alleged environmental risks. For example, BASF has recently launched a multifunctional polymer for hair care formulations, which it claims removes the need for potentially hazardous silicones. The secretary general of the Centre Européen des Silicones (CES), Dr Michel De Poortere, dismissed this suggestion.

Extensive research into safety De Poortere told CosmeticsDesign.com: "We have recently compiled an inventory of 5,000 studies on silicones to help us understand their properties and have come to the conclusion that they are perfectly safe." However, the Canadian government recently proposed Cyclopentasiloxane D5 for the toxic list. The building block of silicone is commonly used in personal care and was adjudged by the authorities to be an environmental hazard to water-based organisms. De Poortere said the CES is working with the Canadian authorities to persuade them that the widely used ingredient is safe. He also said onlookers should be careful not to generalize about silicones and that the category contains a broad selection of chemicals with a variety of properties.

The role of silicones and effectiveness of rivals With regards to the effectiveness of alternatives to silicones, De Poortere said he had seen no evidence that they are as effective and dismissed the idea that they pose a threat to the industry. Silicones have a variety of uses in personal care applications. They add a silky smooth feel to formulations but have other functions including wetting and spreading qualities that ensure smooth and even application. According to a recently-published study from the CES on the socio-economic contribution of the silicone industry, total sales in Europe to cosmetic manufacturers amounted to €100m in 2006.

De Poortere said silicones also boast significant added value in personal care and that the financial value of silicones in finished products is as high as €1000m.

Grant Industries REACH Information

December 02, 2008

Grant Industries has received the final set of pre-registration numbers and we are currently in full compliance with all aspects of REACH for all of our substances. As mentioned below, downstream users of our materials may contact us to make appropriate contractual arrangements with Grant Industries Limited UK as the only representative to ensure that all of your REACH provisions are met. This mainly concerns substances that have not been registered (note: this is different than being preregistered) and that are imported in quantities of at least 1 ton per year, per manufacturer or importer. We thank you for your patience and continuerd support during this next phase of REACH.

October 23, 2008

REACH -Status Update

Our only representative (OR) company, Grant Industries Limited UK, has successfully uploaded bulk pre-registration dossiers into the REACH-IT portal that covers all substances used in every Grant Industries product not exempted under the Annexed REACH definitions. Unfortunately, the REACH -IT portal is completely overwhelmed by global pre-registration activities and we have not yet received our corresponding pre-registration numbers. Our current understanding is the numbers should be received within a few days, but the actual case is now a week or more (as we've been already waiting over one week).

Downstream users of our materials may contact us to make appropriate contractual arrangements with Grant Industries Limited UK as the only representative to ensure that all REACH provisions are met. This mainly concerns substances that have not been registered (note: this is different than being preregistered) and that are imported in quantities of at least 1 ton per year, per manufacturer or importer.

June 2008

Grant Industries is committed to environmentally sustainable development. Grant fully supports the aims of the REACH regulation for improving the levels of human health and the environment.

REACH requires the chemical industry to have and provide a level of knowledge of the properties of chemicals, their uses, and to manage risk through the supply chain. A significant amount of information will need to be generated and exchanged among supply chain partners and with the European Chemicals Agency (EChA). http://echa.europa.eu

Grant Industries fully intends to provide all the required information as efficiently as possible. We are developing a process that will enable the exchange of information between customers, distributors and suppliers.

The following are the key points for our preparation:

We have been working on preparing for REACH since early 2007 and have made significant investments in staffing and information technology to serve you as a world class provider of chemical technologies.
We have ensured all existing substances currently used in Grant Industries cosmetic products have a CAS and EINECS number, with the exception of polymers or other materials historically exempted by EINECS. This allows us to pre-register most of our substances, should the regulations require it.
Not all of our products will require registration. This category includes most, if not all of our polymers.
Grant Industries plans to pre-register all substances for which we have the obligation to do so under the REACH regulation. This includes a number of materials of which we are a downstream users. In such cases, we will be working closely with our suppliers as well as with our distributors to ensure that key raw materials will be supported (and registered where required), and that our manufacturing processes will not be affected by REACH.
In circumstances where we are unable to obtain an ingredient, due to its withdrawal by our suppliers, we will take whatever proactive steps are commercially feasible to re-formulate or revise our product. We shall keep our customers fully informed in these circumstances. Grant Industries will comply with the phased registration requirements (transitional provisions during the period 2010 - 2018) under REACH, but it is premature at this stage to give a commitment that all substances will be registered.
Communication of REACH information for our products will occur both proactively (as in this note) and as specifically requested. Please feel free to contact us for any specific information regarding any of our substances or preparations.

John Gormley
Director of Regulatory Affairs