A recent press release by Kline discusses the challenges faced to SMEs by REACH:

Many small and medium-sized enterprises (SMEs) selling in the European Union could be caught off-guard by the recently implemented REACH regulations requiring registration and approval of chemicals used in manufacturing, according to Kline, a worldwide consulting and research firm.

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a wide-ranging set of EU legislation intended to manage and control the risks to human health and the environment from the use of chemicals.

Many potentially affected companies may be unaware that the REACH legislation applies to them. For example, Kline’s research shows that smaller companies in the recycled paper, secondary raw materials, and metalworking fluids industries are largely unaware of the REACH requirements.

See the press release for the full details.

Nexreg has more information on REACH at the following links:

• REACH Compliance Consulting (English)
• REACH gesetzliche Übereinstimmung Consulting (German)
• Consultoría de conformidad con el REACH (Spanish)
• Consultation de conformité REACH (French)
• REACH適合性コンサルティング (Japanese)
• REACH 준수 컨설팅 (Korean)
• REACH Conformiteit (Dutch)
• REACH 合规咨询 (Chinese – Simplified)

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Nexreg Canada: (519)488-5126 (London, ON)
Nexreg UK: +44 020 7993 5893 (London, UK)
Nexreg USA: (206)418-6663 (Seattle, WA)
E-mail:info@nexreg.com

The NHPD Status of Submissions Report for the month of November is currently available at Health Canada’s Natural Health Producs website.

It appears there’s a real possibility of that happening, according to the article Shoppers must do their homework amid rash of recalls:

In the CPSC’s fiscal year 2007 (October 2006 through September 2007), 61 toys were recalled. Fifty-two of them were made in China, and 19 of those were recalled for lead-paint violations. In the CPSC’s fiscal year 2008 — since Oct. 1 — an additional 25 toys have been recalled. All were made in China, and the majority contained lead paint. Wolfson said consumers should expect more toy recalls in November and December.

See the full article for more information.

An important notice from Health Canada:

UPDATE – Strategy for the Licensing of Natural Health Products (NHPs) with Drug Identification Numbers (DINs)

The purpose of the following notice is to clarify the product licensing application process (i.e. the process for obtaining a NPN or DIN-HM) for those natural health products (NHPs) currently holding Drug Identification Numbers (DIN) issued prior to January 1, 2004. This updated notice supersedes the original notice published earlier this year in April 2007.

Since April 10, 2007, all Transitional DIN Product Licence Applications received by the NHPD must include the information listed below (see: Transitional DIN Application Requirements) or the application may be refused. For Transitional DIN Product Licence Applications received before April 10, 2007 that do not meet the requirements listed below, the applicants have been or will soon be contacted by the NHPD and given the opportunity to complete their applications accordingly.

See the article for the full details.

Nexreg has more information on Drug Identification Numbers (DINs) at the following links:

• Din Submission (English)
• 药品识别码 (DIN) 申报 (Chinese – Simplified)
• Drug Identificatienummer – indiening DIN (Dutch)
• Numéro d’identification du médicament – Soumission de DIN (French)
• Einreichung von Arznei-Identifikationsnummer – DIN (German)
• 医薬品認証番号（DIN）の登録 (Japanese)
• 약품 식별 번호 – DIN 제출 (Korean)
• Presentación del DIN (Spanish)

To speak to a Nexreg representative about registering Drug Identification Numbers (DINs), please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Nexreg Canada: (519)488-5126 (London, ON)
Nexreg UK: +44 020 7993 5893 (London, UK)
Nexreg USA: (206)418-6663 (Seattle, WA)
E-mail:info@nexreg.com

NUTRA Ingredients Europe on new EU flavouring regulations:

Flavourings currently fall under directive 88/388. However the regulatory situation is set to change next year, with the anticipated adoption of FIAP (Food Improvement Agent Package), Joy Hardinge of AJH Consulting told attendees at the SAFC symposium in Grasse, France, last week.

Whereas directive 88/388 covered flavourings, under FIAP (which also relates to additives, enzymes, and the common authorisation procedure) the scope is extended to cover “certain food ingredients with flavouring properties”.

Directive 88/388 covers flavouring preparations, process flavourings, smoke flavourings, and three categories of flavouring substances – natural, nature identical (NI) and artificial.

But with the proposed regulation the scope is set to change.

Firstly, it looks to replace process flavours with ‘thermal process flavours’ – that is flavourings obtained after a heat treatment from a mixture of ingredients that do not necessarily have flavouring properties themselves. One ingredient must contain an amino nitrogen, and one be a reducing sugar.

It also does away with the NI and artificial categories of flavouring substances – a big change, since the claim that a food “contains no artificial flavourings” currently holds much marketing sway.

Click on the above link for more information.

From Google News:

California on Monday launched a lawsuit against 20 companies accusing them of manufacturing or selling toys with illegal quantities of lead, a statement said…

Each violation of the California law known as Proposition 65 was punishable by a fine of up to 2,500 dollars, in theory leaving the firms named in the suit facing a multi-million dollar damages claim.

Companies named in the suit include: Mattel, Fisher-Price, Michaels Stores, Toys R Us, Wal-Mart, Target, Sears, KB Toys, Costco Wholesale, A&A Global Industries, RC2 Corporation, Eveready Battery Company, Kids II, Kmart, Marvel Entertainment and Toy Investments…

Brown told the Times he expected the companies to settle the lawsuit by agreeing to “conditions such as testing or putting independent monitors in foreign countries.”

Click on the above link for the full article.

Electronics Supply and Manufacturing on new regulations from Norway. The full article is an absolute must-read for anyone doing business in Norway; here are the hilights:

There are six hazardous substances that the electronics industry has been struggling to phase-out for a couple of years now: lead, cadmium, mercury, hexavalent chromium, and the flame retardants polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). This is per the European Union’s Restriction of Hazardous Substances (RoHS) Directive, which restricted the use of the substances in electrical and electronic equipment (EEE) to certain maximum concentration values (MCV) in homogeneous material (0.01 % by weight for cadmium and 0.1% by weight for the other five substances).

Other jurisdictions followed or are following the European Community’s example, e.g. California (except for the flame retardants), Korea and China. Most recently, Norway created a proposal for new regulations restricting the use of not less than 18 substances in consumer goods…

Within the 18 restricted substances only two — lead and cadmium — are restricted under the EU RoHS directive. The 18 substances include:

• Brominated flame retardants : hexabromocyclododecane (HBCDD) and tetrabromobisphenol A (TBBPA)
• Chlorinated paraffins
• Arsenic (and arsenic compounds)
• Lead (and lead compounds)
• Cadmium (and cadmium compounds)
• Organic tin compounds: tributyltin compounds (TBT) and triphenyltin compounds
• Fragrance substances: musk ketone and musk xylene
• Perfluorinated compounds
• Surfactants: DTDMAC, DODMAC/DSDMAC and DHTDMAC
• Bisphenol
• Diethylhexylphtalate (DEHP)
• Pentachlorphenol
• Triclosan

More information is availabel in the full article.

From Bernama.com:

Deputy Prime Minister Datuk Seri Najib Tun Razak Tuesday called on chemical industry players, especially small and medium enterprises (SMEs), to be proactive in meeting the challenges posed by the European Union (EU)’s new chemical legislation known as REACH.

REACH (Registration, Evaluation and Authorisation of Chemicals) was formally proposed in December 2006 by the EU Council of Environment Ministers and came into effect from June 1, 2007.

The proposal requires industry players, including producers, importers and users of chemicals to provide public information on the chemicals they produce or import and the risks associated with their use.

“Although REACH places the responsibility on EU-based entities, Malaysian exporters to the EU will be indirectly affected as substantial information will be required by the EU importers for registration and authorisation purposes,” Najib said.

See the article for the full details.

Nexreg has more information on REACH at the following links:

• REACH Compliance Consulting (English)
• REACH gesetzliche Übereinstimmung Consulting (German)
• Consultoría de conformidad con el REACH (Spanish)
• Consultation de conformité REACH (French)
• REACH適合性コンサルティング (Japanese)
• REACH 준수 컨설팅 (Korean)
• REACH Conformiteit (Dutch)
• REACH 合规咨询 (Chinese – Simplified)

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Nexreg Canada: (519)488-5126 (London, ON)
Nexreg UK: +44 020 7993 5893 (London, UK)
Nexreg USA: (206)418-6663 (Seattle, WA)
E-mail:info@nexreg.com

From a recent release:

The Natural Health Products (NHP) Ingredients Database has been modified to
meet additional requests for change and added features which were not part
of our previous release…

We have also revised the following guidance documents:

- NHP On-line System Standard Terminology Guidance Document – The
objective of this document is to provide guidance on the scientific
standards and terminologies which have been adapted to facilitate the
exchange and practical use of natural health product information in the NHP
On-Line System.

- NHP Ingredients Database Web Application Guidance Document – This
guide was developed to help users understand how to search and navigate the
NHP Ingredients Database using the on-line Web application. It also
provides an overview of the database, the use of the web application and
guidance on using the search functionality and navigation of the detailed
ingredient information.

To obtain a copy of these guidance documents, please write to
“ingredient_support@hc-sc.gc.ca”.

More information on the regulation of natural health products in Canada can be found here.

A release from the OEHHA:

The Air Toxics Hot Spots Information and Assessment Act of 1987 (Health and Safety Code Section 44300 et seq.), requires the California Air Resources Board and the Office of Environmental Health Hazard Assessment (OEHHA) to provide assistance and technical support to Air Pollution Control Districts in regulation of local emissions of air pollutants. In particular, OEHHA is required to develop guidelines for conducting health risk assessments under the program (Health and Safety Code Section 44360 (b)(2)). These guidelines include recommended methodology for conducting chemical- and site-specific risk assessments, and health protective values (Reference Exposure Levels for non-cancer health effects and Unit Risk values for carcinogenic effects)…

Ethylbenzene (CAS Registry Number: 100-41-4) enters the atmosphere both from emissions from industrial facilities and other localized sources, and from mobile sources. It is a natural constituent of crude petroleum and is found in gasoline and diesel fuels. It is also used as a chemical intermediate, primarily in the production of styrene. Ethylbenzene is already identified as a TAC as a result of its listing as a U.S. Hazardous Air Pollutant. For assessment of non-cancer effects, a Chronic Reference Exposure Level was adopted in 2000. Ethylbenzene was listed under Proposition 65 as a chemical known to the State of California to cause cancer on June 11, 2004, and was classified as Group 2B (possibly carcinogenic to humans) by the International Agency for Research on Cancer in 2000.

The full release is available here.