REACH24H Consulting Group

Value in Compliance

Displaying items by tag: EU chemical regulations

“COS” is recognition to the quality of a product. Company that wish to enter EU market must first acquire a “COS” number to prove that their API has reached certain level according to relevant EU regulations. EDMF certification mainly aims to regulate manufacturers of preparation and finished goods. Without both companies may not be able to enter EU market.

Our Service Includes:
>> Help company to apply COS number application
>> Help company to confront possible on-site audit
>> Help manufacturer of preparation and finished good to complete EDMF certification
>> Compilation of document covered in EDMF submission materials for API-related companies

About REACH24H
REACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory experts, toxicologists, environmental risk assessors, chemical engineers and IT software development engineers to provide cost-effective access to the marketplace for the clients. REACH24H Consulting Group is also the sub-company of Centre Testing International Corporation (CTI) , a publicly traded company on the Chinese Stock Exchange(300012.SZ). CTI is China’s leading product testing, inspection, certification, and consulting firm, providing comprehensive services for virtually all consumer products. For more information on REACH24H, please Contact us or visit About us.

Published in COS & EDMF

According to Article II of Regulation (EC) No 1223/2009, 'a ‘cosmetic product’ shall meanany substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.'

EU Cosmetics Suppliers have to Comply with:
>>EU Cosmetics Directive 76/768/EEC;
>>New EU Cosmetic Products Regulation (EC) No 1223/2009;
>>REACH Regulation (EC) No 1907/2006;

The Cosmetic Directive 76/768/EEC entered into force in 1976 and provided the main rules for composition, labelling and packaging of cosmetic products. From 11 July 2013, Regulation (EC) No 1223/2009 will replace the Cosmetics Directive. However, some of the provisions of Regulation (EC) No 1223/2009 will apply to substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) from 1 December 2010.
The principal aim of this Regulation is to protect public health by harmonizing the previously laws and regulations concerning cosmetic products in the European Union. The Regulation lays down rules on the composition, labelling and packaging of cosmetic products that are to be adopted throughout the EU member states. 

Compliant Responsibility under EU Cosmetics
(i) Safety Report that provides a safety evaluation of cosmetic products, The safety report must contain: quantitative and qualitative composition of the product, information about impurities and information on packaging materials toxicological profiles of the substances used.
(ii) Product Information File (PIF) that the cosmetic product distributor must create and keep for a period of ten years from the last distribution. The Responsible Person (RP) must also have access to the PIF.
(iii) Provisions on Nanomaterials are included for the first time, as the influence of new technological advances is increasingly felt in the cosmetics industry
(iv) EU-wide notification method
Though the legal implementation date, July 11, 2013, of the Cosmetics Regulation is several years away, it is advisable for cosmetic producers, whose products may have long expiry dates, to apply the changes at the earliest opportunity.

Most of cosmetic products belong to chemical preparations (mixtures) under REACH regulation, so each chemical substance or ingredient shall comply with EU REACH. At REACH24H, we offer integrated and cost-effective compliance solutions for the entry of cosmetic products into the EU.

Our Service Includes:
>>Preparation of product information file("PIF");
>>Safety assessment report;
>>Act as responsible person(for non-EU companies);
>>Pre-market notification;
>>Advice on labelling and languages;
>>EU REACH services

About REACH24H
REACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory experts, toxicologists, environmental risk assessors, chemical engineers and IT software development engineers to provide cost-effective access to the marketplace for the clients. REACH24H Consulting Group is also the sub-company of Centre Testing International Corporation (CTI) , a publicly traded company on the Chinese Stock Exchange(300012.SZ). CTI is China’s leading product testing, inspection, certification, and consulting firm, providing comprehensive services for virtually all consumer products. For more information on REACH24H, please Contact us or visit About us.

Published in EU Cosmetics

EU BPR came into force on Sept. 1st 2013. It aims to harmonize the European Market for biocidal products and their active substance and at the same time to provide a high level of protection for humans, animals and the environment.
BPR regulates strictly its authorization deadline, and EU commission, ECHA, and all members of EU are in preparation for BPR’s enforcement. Industries are working hard on studying BPR and preparing for compliance, because only products complying with BPR can have access to EU market.

Our Service Includes:
>>Compliance strategy formulation for biocidal product
>>Product analysis and advice to constituent improvement
>>Early regulatory warning
>>Keep informed of active substance supplier list
>>Biocidal product authorization application
>>Label compilation of treated article
>>Active substance search

Why Choose Us?
Since 2008, REACH24H has kept an eye on BPD, and all the time followed the newly enforced regulation——BPR. Since 2010, we have been the largest Chinese provider of chemical regulatory compliant service.

Our Strength
>>Experienced Expert Team Support
>>Strict Quality Control System
>>Close Collaboration with Plenty of Certified Test Facilities
>>Good Communication with Competent Authorities
>>Fast Response to Clients Inquiries and Controlling Cost
>>Obeying the Code of Ethics, Respecting the Confidentiality and Privacy of our Clients
>>Excellent Project Management

Our Achievements

Our Unremitting Effort in Regulatory Compliance with EU BPR
Experts with solid toxicological and eco-toxicological background in both research and regulatory affairs form the current ‘EU BPR’ unit in our technical department. Difficulties in authoring risk assessment, the identification of substance and strategy for data collection, REACH24H has immense knowledge basis along with experiences as backup.
During the past years, we have built strong relationships with governmentsofficial institutions and world industry leading companies, like ECHA, CRC-MEP, NRCC, CRCIF, ACC, The Wercs, ChemADVISOR (Our Partners). On June 8, 2011, REACH24H sign with the Wanxiang International, and became the first Lead Registrant (LR) in China as a third-party consultant agency. Up till now we have successfully handled more than 500 EU Reach registrations as well as 7 LR cases.
Since 2010, we established long-term cooperation with numbers of industry leaders and associations as their only EU Reach compliant service provider, such as China Rubber Industry Association, China Chamber of Commerce of Foodstuffs and Native Produce, China Certification & Inspection Group Guangxi Co. Ltd, China Chamber of Commerce of Metal, Minerals & Chemicals Importers & Exporters. On May 5, 2010, REACH24H sign up with China Petroleum & Chemical Group (Sinopec Group) which ranked the fourth of the Global Fortune 500 in 2013.
In the past several years, we have brought our latest research and case study to the world by holding seminars and webinars in a regular basis. We have our workshops held in Europe, Asia and North America, cooperating with leading regulatory services providers, law enforcement authorities and industry associations. We hold Chemical Regulation Annual Conference (CRAC) every year since 2009. In addition, our experts have always been invited by official institutions and chemical-related companies to conferences all over the world introducing chemical regulations and their updates.
We grow with companies for advancing regulatory consciousness. Till the end of 2013, we have our workshops held in more than 20 cities. In the year of 2014, several events have already been carried forward, and many others are afoot.

 Till the end of 2013, we have our workshops held in more than 20 cities.

Published in EU BPR

The CLP Regulation (Regulation (EC) No 1272/2008) is the new European regulation on classification, labeling and packaging of chemical substances and mixtures (preparations). This Regulation entered into force on 20th January 2009. CLP Regulation will replace Directive 67/548/EEC (short as DSD) relating to the classification, packaging and labeling of dangerous substances as well as Directive 1999/45/EC (short as DPD) relating to the classification, packaging and labeling of dangerous preparations.
It introduces in the EU new criteria for classification and labeling, based on the United Nations’ Globally Harmonized System (UN GHS). From 1st December 2010, companies should apply the new classification regulation to substances, and from 1st June 2015 to mixtures (preparations). It also provides rules for the notification of substances to the Classification & Labeling Inventory established by the European Chemicals Agency (ECHA).

Compliant Responsibility under EU CLP
Companies should classify substances or mixtures, submit C&L (Classification and Labeling) notifications, label and package their products compliant with the CLP regulation, and prepare CLP compliant SDS (Safety Data Sheet). The new Classification, Labeling and Packaging Regulation (CLP) will affect you if you are:
>>a registrant under EU REACH Regulation
>>a manufacturer or importer of substances or mixtures (preparations) that you place on the EU market;
>>a downstream user, - you use substances or mixtures supplied to you for the formulation of other products that you place on the market, e.g. adhesives, cleaning products, paints, motor oils;
>>a distributor (retailer), - you store and place on the market a substance or a mixture for others;
>>a producer or importer of articles that are explosive or that contain substances that are intentionally released or are on the Candidate List of Substances of Very High Concern (SVHC):
>>Involved in research and development of chemicals.

At REACH24H, we provide tailored solutions to CLP compliance. We can help you classify your substances and mixtures, notify the classification and labeling of your products to the C&L Inventory, prepare CLP compliant labels and the latest SDS.

Our Service Includes:
>>Update product classification
>>Compile labeling and package in accordance with CLP format
>>CLP-compliant SDS compilation
>>Multi-linguistic SDS/labeling compilation support (English, German, French, etc.)
>>Only representative (OR) service
>>Compilation and delivery CLP-compliant C&L notification dossier
>>SDS auditing
>>SDS compilation according to REACH regulation
>>EU CLP compliance training course

Why Choose Us?
As early as in 2006, before EU Reach came into force, our founders had kept an eye on it. 2007, REACH24H team assembled and started training session. 2008, we were the first to submit Reach pre-registration in the world, and was the first to have got pre-registration number, new substances registration number, and phase-in substances number in China. Since 2010, we have been the largest Chinese provider of chemical regulatory compliant service.

Our Strength
>>Experienced Expert Team Support
>>Strict Quality Control System
>>Close Collaboration with Plenty of Certified Test Facilities
>>Good Communication with Competent Authorities
>>Fast Response to Clients Inquiries and Controlling Cost
>>Obeying the Code of Ethics, Respecting the Confidentiality and Privacy of our Clients
>>Excellent Project Management

Our Achievements

Our Unremitting Effort in Regulatory Compliance with EU CLP
Experts with solid toxicological and eco-toxicological background in both research and regulatory affairs form the current ‘EU CLP’ unit in our technical department. Difficulties in authoring risk assessment, the identification of substance and strategy for data collection, REACH24H has immense knowledge basis along with experiences as backup.
During the past years, we have built strong relationships with governmentsofficial institutions and world industry leading companies, like ECHA, CRC-MEP, NRCC, CRCIF, ACC, The Wercs, ChemADVISOR (Our Partners). On June 8, 2011, REACH24H sign with the Wanxiang International, and became the first Lead Registrant (LR) in China as a third-party consultant agency. Up till now we have successfully handled more than 500 EU Reach registrations as well as 7 LR cases.
Since 2010, we established long-term cooperation with numbers of industry leaders and associations as their only EU Reach compliant service provider, such as China Rubber Industry Association, China Chamber of Commerce of Foodstuffs and Native Produce, China Certification & Inspection Group Guangxi Co. Ltd, China Chamber of Commerce of Metal, Minerals & Chemicals Importers & Exporters. On May 5, 2010, REACH24H sign up with China Petroleum & Chemical Group (Sinopec Group) which ranked the fourth of the Global Fortune 500 in 2013.
In the past several years, we have brought our latest research and case study to the world by holding seminars and webinars in a regular basis. We have our workshops held in Europe, Asia and North America, cooperating with leading regulatory services providers, law enforcement authorities and industry associations. We hold Chemical Regulation Annual Conference (CRAC) every year since 2009. In addition, our experts have always been invited by official institutions and chemical-related companies to conferences all over the world introducing chemical regulations and their updates.
We grow with companies for advancing regulatory consciousness. Till the end of 2013, we have our workshops held in more than 20 cities. In the year of 2014, several events have already been carried forward, and many others are afoot.

 Till the end of 2013, we have our workshops held in more than 20 cities.

Published in EU CLP

Overview

REACH is the European Regulation on chemicals and their safe use. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH regulation came into force in 1 Jun 2007, establishing a uniform system for the control of chemicals manufactured or imported to the EU.
Following the introduction of REACH, chemical substances on their own or in mixtures, manufactured or imported to the EU in quantities at above 1 tonne a year must be registered with the European Chemicals Agency (ECHA). This obligation also applies in certain cases to substances in articles. Failure to register means the company is no longer allowed to manufacture the substance in or import it to the EU.

The core contents under EU REACH can summarized as follows:

• Four Obligations:

Registration, Evaluation, Notification/Authorisation, Restriction and e(SDS)

• Three Chemical Objects:

Substances (phase-in substance and non-phase-in substance), Mixture, Article

• Four Major Roles:

EU Manufacturers, EU Importers, Companies acting as Only Representatives, Downstream Users

• Three Administrative Tools:

REACH-IT for information communication, IUCLID for creating dossier, Chesar

REACH Supply Chain Compliance System-NEWRSCC

NEWRSCC is the acronym for the NEW REACH Supply Chain Compliance System. Designed by REACH24H, it is an upgraded REACH compliance IT tool based on the RSCC system. Applying this specially-designed IT solution, NEWRSCC help manage related REACH compliance data and acquire the tonnage coverage certificates on the supply chain with a higher level of security. This upgraded tool has a friendly user interface, a compact operation procedure and a strict and confidential mechanism. It assures the prompt communication of different trade roles and satisfies REACH compliance requests through the supply chain.

Other Obligations under REACH

If a given substance constitutes a risk to human health or the environment, ECHA and the Member States will evaluate the information submitted by companies, and even include the substance in the Authorisation List or Restriction List. Manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation. Restrictions may limit or ban the manufacturing and placing on the market or use of a substance.

How to Comply?


FAQ

Q: If a non-Phase-in substance is used as intermediate, should we submit an inquiry before registration?

A: The inquiry is independent from the use of a substance. No matter whether a non-Phase-in substance is used as intermediate or not, it should submit an  inquiry before registration. Once the inquiry is answered by ECHA, for intermediates below 1000t/a, we could just use the free data and submit the available data for registration.

Q: If a non-EEA manufacture submits a registration under one OR, could he appoint another OR for authorisation?

A: Regardless whether the substance in Annex XIV has been registered or if an OR has participated in the registration, the non-EEA manufacturer may appoint another OR to apply for authorisation. The ORs used for the registration and authorisation processes may be different entities.

Registration Timeline


Applicable Scope

Registration shall apply to any of the following conditions under EU REACH:

• Substance as such, Manufacture / Importation > 1 t/a;

• Substance in a mixture, Manufacture / Importation > 1 t/a;

• Substance intended to release in an article, Manufacture / Importation above a concentration of 0.1% (w/w) & > 1 t/a ;

Note: The release of a substance from an article is deliberately planned and has a specific function in the use of the article. This is frequently not the main but an accessory function of the object, such as air freshener.

Registration Bodies

• Manufacturers and importers of substances, mixtures, article in EU;

• Non-EU companies can export to the European Union through two different routes under REACH: either via an importer who has registered the substance, or by appointing an Only Representative (OR).

Registration Types

REACH covers different types of registrations: full registration (Article 10) and intermediate registration (Article 17 and 18).

Regular Registration Procedure

Our Services

  • Only Representative (OR) Service

  • Inquiry Service

  • Registration Service

  • Lead Registrant Service

  • OR Exchange Service

  • Third Party Technical Support

  • Testing Supervision Service

  • PPORD Notification Service

  • Exemption Declaration Service

  • SIEF Management

  • Exposure Scenario (ES) Development

  • Chemical Safety Assessment and Chemical Safety Report   (CSR) Preparation

  • Extended Safety Data Sheet (eSDS) Preparation

  • Compliance Check of Qualified Suppliers

  • REACH Supply Chain Compliance System-NEWRSCC

  • SVHC Notification Service ·  Authorisation Application Service

  • REACH Training Service ·  HSA Inspection Assistance Service

  • Consortium Supporting Service

Why REACH24H?

Technical Strength

  • Technical expertise to ensure highly professional support

  • Over 150 professionals with extensive academic and practical experience in chemistry, toxicology, and other related fields

  • Close collaboration with certified test facilities

  • Regular communications with ECHA and experts

Achievements

  • Consulting services for PetroChina to obtain REACH   Registration Number

  • LR service experience on rubber, flavor & fragrance, chemical, pharmaceutical, and agrochemical industries, among others

  • Strict quality control system to ensure 100%  success rate:

3000+  EU REACH Registrations

30+ Lead Registrations

Published in EU REACH
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