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R. E. A. C. H.

An Assessment and Strategy for Planning, Implementation and Compliance for R.E.A.C.H.

Registration Evaluation Authorization of Chemicals

R.E.A.C.H. was passed in the European Union on December 18, 2006 and will take effect June 1, 2007. The first activity available within R.E.A.C.H. will be a pre-registration workshop in Bonn, Germany on June 21, 2007. R.E.A.C.H. is administered by the European Chemical Agency located in Helsinki, Finland.

Following guidance from the European Chemical Agency, Biosil Technologies, Inc. will adopt The Precautionary Principle in its R.E.A.C.H. initiative, for we recognize that it is for industry to ensure that we manufacture, place on the market and use ingredients that do not adversely affect human health and the environment.

Pre-registration will open on June 1, 2008 through December 1, 2008 when existing EINECS chemicals are eligible to pre-register. Note: ELINCS ingredients are considered registered. There are three phases for pre-registration. First, collecting the available information; second, locating other relevant information holders and finally sharing data. Pre-registration imparts transitional ‘Phase In’ benefits to substances. After pre-registration, manufacturers and importers carry out the CSA (Chemical Safety Assessment > 10 tonnes per year) and write a CSR (Chemical Safety Report). Upon registration a Registration Dossier is submitted.

Biosil Technologies, Inc., as an importer into the EU will pre-register its ingredients. This will allow Biosil Technologies, Inc. to participate in S.I.E.F.S. (Substance Information Exchange Forum) and allow appropriate time to prepare data dossiers. We will work closely with all customers on any product formulations in order to maintain both compliance and a high capacity for innovation. This will require information sharing within the supply chain and enhanced transparency. Biosil anticipates data collection through the period from June 1, 2007 to May 31, 2018.

Biosil Technologies, Inc. will only market ingredients that ensure a high level of protection of human health and the environment. In harmonization with the European Cosmetics Directive, Biosil will only market ingredients that ensure a high level of consumer protection. We recognize that the safety of cosmetic products must be substantiated by a qualified safety assessor before the products are placed on the market.

Cosmetic ingredients are regulated under the Cosmetics Directive (human-health aspects) and under R.E.A.C.H. (environmental and occupational aspects). We anticipate that the CTFA (Cosmetics, Toiletries and Fragrance Association) in the US will assist member companies by coordinating the cosmetic industry’s implementation strategy. Specifically this means developing guidance documents for the cosmetics industry.

All substances whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations or in an article and supplied at one tonne or more per calendar year, per legal entity, are subject to R.E.A.C.H. Biosil Technologies, Inc. will seek RIP 3.1 through RIP 3.10 (R.E.A.C.H. Implementation Project) guidance documents from the R.E.A.C.H. Agency. Therefore, we will embark on one year of anticipation, organization and preparation followed by six months of implementation. This will begin with an inventory of our purchased raw materials and supplied ingredients, the formation of our R.E.A.C.H. team, preparation of an action plan and dialog with both suppliers and customers.

R.E.A.C.H. will cover additives and impurities but will exclude removable solvents that do not change substance composition. R.E.A.C.H. will require ingredient name, molecular and structural formula and composition (including additives and impurities). Biological ingredients are named by species, synthetic ingredients are named by starting material and processes are defined by the type of chemical reaction. Polymers are exempt from registration within a specific definition.

Pre-registration is the SIGNIFICANT first action to take. Limited pre-registration data will be sent to the European Chemicals Agency. Registration applies to substances manufactured / imported at or above one tonne per calendar year / per legal entity / for all uses. Registration numbers will appear on SDS (Safety Data Sheets).

In January 2009, the Agency will publish the list of pre-registered substances on its website (no company names).Upon pre-registration all pre-registrants become members of a substance-specific S.I.E.F. automatically. Each S.I.E.F. is operational until June 2018. A CDA (Confidential Disclosure Agreement) is recommended since all parties are subject to a “Duty of Care.” In practice, companies are expected to start discussions when all or most pre-registrants are known, or even before pre-registration.

Intrinsically, R.E.A.C.H. seeks to discern between ‘safe and unsafe’ substances. Upon final registration, data must show that a substance is “adequately controlled,” including a reassessment of classification and labeling and consideration of other European Union obligations (‘Due Diligence’). Note that European Member States will have access to R.E.A.C.H. data, such as the monitoring of the ‘fate’ of substances. These Member States could use R.E.A.C.H. data for purposes outside of R.E.A.C.H.

R.E.A.C.H. http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

Disclaimer: All information presented above was excerpted from information obtained from the REACH Summit held in Paris, France on April 16, 2007. It is offered as a good faith assessment of some of the anticipated expectations forthcoming from R.E.A.C.H. However, it is only offered as the opinion of Biosil Technologies, Inc. and should not be relied on for accuracy, completeness or any binding decisions. Biosil Technologies, Inc., its representatives, successors and assigns do not guarantee, warrant or assure anything expressed herein. Readers are advised to seek competent counsel for any clarifications or interpretations and not to rely on any opinions stated herein.