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Safe Certification
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All the baby & children's products supplied by Globaby Co. Ltd comply with CCC, ASTM, CE, EN71, FDA, GS, Oeko-Tex Standard 100 and RoHS.

CCC
In December 2001, the State General Administration of Quality Supervision, Inspection and Quarantine of the People¡¯s Republic of China issued the Regulations for Compulsory Product Certification. The Compulsory Product Certification System began to replace the original Quality License System of Commodity Inspection and Safety Certification System for Electrical Equipment. The abbreviation of China Compulsory Product Certification is CCC or 3C. It is the legal compulsory safety certification system and the basic approach to protect the consumers¡¯ rights and interests and protect the personal and property safety, which is adopted widely by international organizations.

China Compulsory Certification System goes into effect on May 1, 2002. In accordance with the joint announcement No.38 [2003] by the State General Administration for Quality Supervision and Inspection and Quarantine of the People¡¯s Republic of China and the Certification and Accreditation Administration of the People¡¯s Republic of China, the time for implementing the supervision and management of the market for compulsory product certification was decided on August 1, 2003.

The Products subject to Compulsory Product Certification covers 135 products divided into 20 categories, including household appliances, motor vehicles, motorcycles, safety glasses, medical devices, lighting apparatus, cables and wires, etc.

ASTM
Organized in 1898, ASTM International, originally known as the American Society for Testing and Materials (ASTM), is one of the largest voluntary standards developing organizations in the world. ASTM is a not-for-profit organization that provides a forum for the development and publication of voluntary consensus standards for materials, products, systems, and services.

ASTM's members, representing producers, users, consumers, government, and academia from over 100 countries, develop technical documents that are a basis for manufacturing, management, procurement, codes, and regulations.

These members belong to one or more committees, each of which covers a subject area such as steel, petroleum, medical devices, property management, consumer products, and many more. It is these committees that develop more than 12,000 ASTM standards that can be found in the 77-volume Annual Book of ASTM Standards.

CE
The CE mark (officially Communaut' Europeen marking) is a mandatory marking on certain products, which was introduced by the European Commission, and adopted in July 1993.

The CE Mark is not a quality mark, but rather a symbol that indicates conformity to the legal requirements of the European Union (EU) Directive.

The products subject to CE covers products including Appliances Burning Gaseous Fuels (AppliGas); Cableway Installations to Carry Persons;Low Voltage Electrical Equipment;Construction Products;Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex);Explosives for Civil Uses;Hot Water Boilers; Household Refrigerators & Freezers; Lift; Machinery; Marine Equipment; Medical Devices; Active Implantable Medical Devices; In Vitro Diagnostic Medical Devices ; Non-automatic Weighing Instruments; Radio Equipment & Telecommunications Terminal Equipment (R&TTE); Personal Protective Equipment (PPE); Simple Pressure Vessels; Pressure Equipment; Recreational Craft; Toys; Trans-European Conventional Rail System.

EN71
EN71 is European safety criterion for toys. It includes EN 71 Part 1: physical & mechanical Test; EN 71 Part 2: flammability Test; EN 71 Part 3: Toxic Elements Test; EN 71 Part 4: Experimental Set for Chemistry; EN 71 Part 5: Chemistry Toys (Sets) other than Experimental Sets;  EN 71 Part 6:Graphical Symbol for Age Warning Labeling; EN 71 Part 7:EN 71 Part 7 Finger Paints.

FDA
The Food and Drug Administration (or FDA) is an agency of the United States Department of Health and Human Services established in 1906.

FDA's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. The laws FDA enforces and the relative risks that the products pose to consumers dictate these differences.

Some products -- such as new drugs and complex medical devices -- must be proven to be safe and effective before the companies launching them on the market. The agency also must approve new food additives before they can be used in foods. Other products -- such as x-ray machines and microwave ovens -- must measure up to performance standards. And some products -- such as cosmetics and dietary supplements -- can generally be marketed with no prior approval.
At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great -- especially for products used to treat serious, life-threatening conditions.
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs.
FDA has streamlined its review process for medical products in recent years to help speed important new treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.

GS
The Geprüfte Sicherheit ("Tested Safety") or GS mark is a voluntary certification mark for technical equipment. The German safety approval mark shows conformity with the German Equipment Safety Law.

It is a recognized mark for electrical products, such as office equipment, household appliances and industrial equipment.

Oeko-Tex Standard 100
The Oeko-Tex Standard 100 comprehensively addresses the Human Ecology component of textile products. It evaluates and screens for any harmful substances present within processed textiles intended to come into contact with consumers.
The Oeko-Tex Standard 100 encompasses the industries established testing criteria for textile products and also addresses quality assurance and test procedures. It not only takes into account the finished textile goods, but also any associated accessories and "grey" product areas such as fibres, yarns and buttons. In this standard, the relevant harmful substances are defined together with limiting values, taking into consideration the intended use of the product. For example, the clothing products close to the skin, such as underwear and baby products.
An integral part of the Oeko-Tex Standard 100 system is the Quality Assurance by the producer who has to ensure that that products manufactured or sold are representative to the samples tested for the Oeko-Tex certificate. Spot testing by the Oeko-Tex institutes of products selected from both the production and those available on the market is carried out, providing an additional control mechanism.
The tests themselves are carried out by a number of "Oeko-Tex" recognized institutes. All of these institutes follow the same methods and are appointed by the Oeko-Tex Association to license the Oeko-Tex 100 mark, "Tested for harmful substances according to Oeko-Tex Standard 100".
RoHS
The main objective of the RoHS Directive is the restriction of hazardous substances in electrical and electronic equipment, for the protection of human health and environmentally sound recovery and disposal of waste. The Directive applies to all equipment operating up to 1000 VAC and 1500 VDC and contained in a list of 8 categories including electric bulbs and luminaries in households. There are currently no restrictions on medical devices and control and monitoring equipment.


Equipment category

Large household appliances

Lighting equipment

Small household appliances

Electrical and electronic tools

IT and telecommunication equipment

Toys, leisure and sport equipment

Consumer equipment

Automatic dispensers

The use of the following substances is restricted or its application prohibited.


Substance

Application

Lead(Pb)

Solder, power cords, wired, plastics, component finish

Mercury (Hg)

Switch, LCD monitor, relays, bulbs

Cadmium (Cd)

Power cords, wires, contact points

Hexavalent chromium (CrVI)

Surface treatment of enclosures

Polybrominated Biphenyl (PBB)

Plastics, printed circuit boards

Polybrominated Diphenyl ether (PBDE)

Plastics, rubber, printed circuit boards

Schedule RoHS Directive


Date

Schedule

February 13. 2003

Directive published in Official Journal of EU

August 13. 2004

Member states implement national regulations

February 13. 2005

Commission to review scope of Directive

July 1. 2006

Electrical and electronic equipment must comply with Directive

Obligations of manufacturers
All equipment, falling in one of the 8 categories, entering the EU from 1 July 2006 should not contain the above substances or its application within the limits or exemptions set out in the annex to the Directive. Medical devices and monitor, and control instruments are currently excluded from the Directive. For appliances containing a large number of materials, it is not economically feasible to test all materials and components of single appliance.

 

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