STR/CSCC Approved As Third Party Validator for
C-TPAT Pilot Project

We are proud to announce that jointly with STR, CSCC has been approved as a third-party validator for a one-year C-TPAT pilot project. The pilot project aims to clear the backlog of C-TPAT participants in China that are eligible for validation, and marks the first time in the history of the C-TPAT program that third-party monitors have conducted validations. CSCC/STR is one of 10 companies to have been approved as third-party monitors for the project. For more information about our supply chain security services, please contact Nick Allen nallen@intlcompliance.com.

FDA UPDATES

FDA Good Manufacturing Practice for Dietary Supplements

On June 22 the FDA published its long anticipated final rule on FDA Good Manufacturing Practice for Dietary Supplements. This regulation will have a dramatic effect on the industry which has been called by the media as "the wild west" because of the perception of poor quality and limited over sight by the FDA. Compliance to these GMPs is required within a year for large companies (greater than 500 employees) and by 2010 for very small companies (less than 20 employees). The key requirement of these GMPs is development of a master manufacturing record which defines and requires documentation of each step in the manufacturing process with quality control approval. Raw materials need to be identified and possible contaminants identified and tested for. Manufacturers must have a testing program for finished products for testing purity, strength, identity and composition.

Shuster has been auditing manufactures and testing for many years and experience has shown that many companies are not in compliance with these regulations. Shuster has the expertise to assist companies in compliance with these regulations through auditing and testing. The expectation is that many companies will be coming to Shuster to certified compliance to these regulations, a requirement of the retailers. For more information, please contact Ron Peterson at.ron.peterson@shusterlabs.com .

Read more on GMPs in a press release distributed by the Council for Responsible Nutrition.

EU and FDA sign food safety risk agreement

On July 3, The European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) signed the first U.S./European agreement on food safety risk. This is the first formal international cooperation agreement that EFSA has signed and the first formal step in cooperation between the two bodies.

According to an EFSA press release, the agreement is designed to facilitate the sharing of confidential scientific and other information between the two agencies. The formal agreement ensures legal protection of the confidential information. Informal cooperation has already been established.

Read the agreement from the EFSA website.

TOY INDUSTRY UPDATES

Transition Period for ASTM F963-07 Revision

The new revision ASTM F963-07 was published in May 2007 which had already replaced the old version ASTM F963-03.

Numerous recalls have been made by CPSC over these two years for the intestinal injuries caused by ingested magnets and the most recent case was reported on July 5, 2007 for an eight-year-old girl who was hospitalized after swallowing loose magnets. Extensive surgery was required to remove the magnets and repair intestinal perforations. Full text of the CPSC recall can be accessed through: http://www.cpsc.gov/cpscpub/prerel/prhtml07/07231.html

In view of the urgency of the magnet issue, Toy Industry Association, Inc. (TIA) recommended all manufacturers, importers and retailers to ensure products produced after January 1, 2008 meet the new ASTM Magnet Requirements.

For all other additions and changes to the standard ASTM F963-07, products produced after June 1, 2008 will be expected to meet the revised Standard.

Specialized Technology Resources (H.K.) Ltd. has obtained HOKLAS accreditation various toy safety standards. For details of our HOKLAS scope of accreditation, please visit: http://www.itc.gov.hk/en/quality/hkas/doc/hoklas/036.pdf .

For more information in the US contact Susan DeRagon at Susan.DeRagon@strus.com ; in Asia contact Victor Kam at victor.kam@strhk.com .

New Amendments to Toy Safety Standard-ISO 8124-1:2000

The International Organization for Standardization (ISO) published two amendments: ISO 8124-1:2000/Amd.1:2007 and ISO 8124-1:2000/Amd.2:2007 on June 1, 2007.

Significant changes are on the re-classification of the age-break level and addition of the new hemispheric-shaped toys requirements under Amendment 1, and the switch of the acoustic requirements from informative to normative status under Amendment 2.
Click here for details:
http://www.shusterlabs.com/monitor/New%20Amds%20to%20Toy%20Safety%20Standard.pdf

Global Sourcing Quality Management™ Program Helps Ensure the Quality/Safety of Products and Ingredients Sourced Offshore

Shuster Laboratories, an STR Company, announced last month the introduction of a new Global Sourcing Quality Management™ (GSQM) program for companies that source food or dietary supplement ingredients/products in China or other offshore locations. The GSQM™ program will help U.S. companies-manufacturers, suppliers, retailers, and food service operators-that want to ensure the highest level of confidence in their food or dietary supplement ingredients, products, and systems.

Recent quality and safety issues with products sourced in China have amplified concern among the industry and consumers. If a food or dietary supplement company is buying ingredients overseas, directly or through an agent, then they must have a program in place to ensure product quality and safety at all critical points in the supply chain.

Shuster has invested in a specialized testing laboratory at STR's 30,000 s/f Shanghai, China laboratory to support its new GSQM™ program. STR, which is Shuster's parent company, has had QA/QC laboratories in Shanghai and Shenzhen, China (40,000 s/f lab) since 2003 and employs over 500 professional/technical staff in China. Our Shanghai laboratory will help food and dietary supplement companies ensure the quality/safety of products and ingredients sourced in China and other global locations.

The first critical step for companies is conducting a risk assessment. From there, they can build an effective safety program to ensure that the quality and safety requirements for sourced ingredients and products are consistently being met. For more information about Shuster's new program, please contact Tricia Baressi at tricia.baressi@shusterlabs.com .

EVENTS/SEMINAR

Shuster Seminar, "Global Sourcing Quality Management", To Be Presented At The Institute Of Food Technologists (IFT) Food Expo

Are You Buying Ingredients Offshore? Supply Chain Quality and Safety in the global market is a critical factor in the food industry. If you are buying ingredients overseas, directly or through an agent, you are challenged with product quality and food safety at all critical points in the supply chain. Shuster invites you to a seminar on, "Global Sourcing Quality Management", during the IFT Food Expo in Chicago, on July 30, 2007. Read More.

RoHS UPDATES

RoHS enforcement seems to be non-existent or at least many organizations in the US would like to think so. However, enforcement action is taking place over in Europe such as fines but more importantly the potential for temporary sales bans is quite real. The cost to ship products back, recalls, and denial of importation can be an enormous cost to a company that sells into the EU. Read More.

REACH UPDATES

Starting on June 1, 2008, companies manufacturing or importing chemicals into the EU must register substances above one (1) ton. However, for substances that are already on the EU market (the so-called phase-in substances), a temporary exemption from the June 1, 2008 deadline applies. Companies can continue to export to the EU without the need to register until 2010, 2013 or 2018, depending on the quantities they place on the EU market. This will allow a progressive introduction of REACH over a period of 11 years for the estimated 30,000 substances currently on the market above 1 ton.

The delayed registration deadlines only apply to pre-registered "phase-in substances" and only to companies that have pre-registered their substances. Phase-in substances are substances listed on EINECS, the European Inventory of Commercial Chemicals Substances (To find if a substance is listed on EINECS, see: http://ecb.jrc.it/existing-chemicals/ ). Non-phase in substances, which have not previously been placed on the EU market, must be registered before marketing can take place.

For more information, contact Kevin Smith at Kevin.smith@strus.com .

New ASTM Standard for Fire Safety for Candle Accessories

The ASTM F15.45 committee approved a new standard, ASTM F2601-Standard Specification for Fire Safety for Candle Accessories. The new ASTM standard covers flammability of candle rings, candle burners, and potpourri burners. A new labeling requirement for candle rings is included.

For inquiries or other information on candle testing, please contact Bob Cammilleri at Robert.Cammilleri@strus.com or 860-749-8371 extension 254.