How much does REACH registration cost?

REACH late pre-registration is cheap. The market price is between 100 Euros to 500 Euros per substance with discount available for multiple substances. If you appoint an only representative, you need to pay annual maintenance fee on a yearly basis, probably between 100 Euros and 500 Euros per substance per year(discount is also available).

REACH registration is much more expensive. The total cost of registering one substance could reach millions of Euros if your tonnage is very high and your company is the only company registering it. Luckily, REACH encourages data sharing through joint submission, in which case lead registrant and consortium will do most of the work such as GLP testing, preparation of technical dossier and Chemical Safety Report. Member registrants only need to pay lead registrant a fee (i.e, buying a letter of access) to refer to the joint registration data and dossier developed by lead registrant or consortium, and prepare their individual part of registration dossier.

REACH Registration Cost Estimation
The total registration costs mainly consist of three parts:

A.Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is dependent on tonnage band. Data fee varies from substance to substance. It is fixed by consortium or lead registrant. It is also tonnage based.The price of a letter of access for a typical substance is between 2,500 and 15,000 Euros. For example, the letter of access for Iron costs 2500 Euros for 1000t/y+. The letter of access for many petrochemicals cost 10,000 Euros per substance.


B.Consultancy fees paid to consultancy firms to advise the whole registration process and prepare the individual part of registration dossier in iuclid 5. The service fee covers SIEF/consortium communications, data gathering, individual dossier preparation and submission. Some firms charge hourly rates. CIRS usually charges a maximum of 4,000 Euros for this service if Chemical Safety Report(CSR) is part of joint submission. If CSR is not included, CIRS charges extra fees for CSR (8,000 Euros).


C.ECHA fees paid to European Chemical Agency. The fee is dependent on the annual tonnage of the substance and company size. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).

For more information, please go to:
http://www.cirs-reach.com/REACH/REACH_Registration_Costs_Fees.html

Practical CLP Compliance Advice for EU Importers

The CLP Regulation, Article 46, on Enforcement and Reporting, states that “Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation”.

Main Obligations of EU Importers under CLP Regulation:

* should classify, label and package substances and mixtures according to CLP before placing them on the market;
* should notify the classification and labeling elements to the classification and labeling inventory established by ECHA before 3 Jan 2011(Urgent!!!!);
* should update the label following any change to the classification and labeling of that substance or mixture;
* should submit a proposal to the Competent Authority if new information which may lead the change of harmonized classification and labeling is available;
* shall provide Safety Data Sheets(SDS) along the supply chain and update SDS when necessary.



To comply with CLP, EU importers shall do the following four things:

* Chapter One: Classification
* Chapter Two: C& Notification
* Chapter Three: Labeling and Packaging
* Chapter Four: Safety Data Sheet


The full article can be downloaded from here[pdf,280KB]
http://www.cirs-reach.com/clp/CLP_Compliance_Advice_Importers.pdf

EU Tyre Safety Requirement - PAHs and REACH SVHC

The testing requirements of tyre are mainly set out in the European regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals(REACH). The legislation came into force on Jun 1st, 2007 and was implemented on Jun 1st, 2008.

The legislation has a tremendous impact on the tyre industry. Tyres that fail to meet the requirements of REACH shall not be placed on EU market. To comply with REACH, tyre suppliers(manufacturers, importers, retailers and distributors)shall identify and test Polycyclic aromatic hydrocarbons(PAHs) and Substances of Very High Concern (SVHC) in their products. Tyre manufacturers who buy raw chemicals from companies shall ensure that their substances have been registered and their uses have been covered in the registration.

Polycyclic aromatic hydrocarbons (PAHs)
Polycyclic aromatic hydrocarbons (PAHs) are a group of over 100 different chemicals that are formed during the incomplete burning of coal, oil and gas, garbage, or other organic substances like tobacco or charbroiled meat. PAHs are known for their carcinogenic, mutagenic and teratogenic properties. Plastics and rubber products such as tyre are high risky materials containing PAHs.

REACH Annex XVII has placed a restriction on the use of 8 PAHs in tyres and extender oil. Tyres will not be allowed to be placed on EU market if 8 PAHs exceed certain concentration thresholds listed in the following table. The restriction also applies to the marketing of tyres in EU

Substances of Very High Concern (SVHC)
The minimum criteria for Substances of Very High Concerns（SVHCs）are set forth in Article 57 of REACH Regulation:

- carcinogenic, mutagenic or toxic to reproduction (CMRs);
- persistent, bio-accumulative and toxic (PBTs);
- very persistent and bio-accumulative (vPvBs);
- seriously and / or irreversibly damaging the environment or human health, such as - substances damaging the hormone system;

Tyres belong to the “article” category under REACH. Suppliers of tyres must fulfill the following obligations when a SVHC on candidate list is present:

- Communication Requirement: Suppliers of tyres which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information (such as SDS, substance declaration) to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request.This information must contain as a minimum the name of the substance.

- Notification: EU producers or importers of tyres have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration and restriction requirements. Please refer to Swiss Chemicals Ordinance (ChemO) and Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.

Related Substance Restrictions

REACH Substance of Very High Concern (SVHC)

REACH Restricted Substances

EU RoHS/RoHS 2

China RoHS 2

Norway PoHS

Swiss Chemical Risk Reduction Ordinance

California Proposition 65

Persistent Organic Pollutants (POPs)

Ozone-depleting Substances

Mercury and Its Compounds

Introduction to China REACH

The Measures for Environmental Administration of New Chemical Substances (MEP Order 7) was issued in Jan 2010 by China MEP and came into force on 15 Oct 2010. This regulation is similar to EU REACH regulation and is also known as "China REACH".

MEP Order 7 requires that manufacturers and importers submit new substance notifications and obtain approvals from the Solid Waste and Chemical Management Centre of China MEP (MEP-SCC) prior to production or importation. A foreign exporter may appoint a Chinese agent to submit notifications.

The notification requirement not only applies to new substance on its own, in preparation or articles intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, cosmetics, food additives and feed additives, etc.

Inventory of Existing Chemical Substances Produced or Imported in China (IECSC)

A new substance is defined as a substance other than those listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There are 45,612 substances in IECSC (updated in 2013) among which 8,486 substances do not have CAS numbers.

Read more about IECSC and how to search.

China New Substance Notification - Exemptions

The following substances are exempt from new substance notifications under MEP Order 7.

• Chemical substances subject to other existing laws and regulations (pharmaceuticals, pesticides, cosmetics, food additives, etc.);
• Naturally occurring substances;
• Impurities (content of a single impurity <10 all="" by-products="" content="" impurities="" li="" of="" or="" total="" w="" waste="">
• Special categories such as glass, cement, alloys, non-isolated intermediates (*), articles.

*On-site isolated intermediate is regarded as non-isolated intermediate in China and thus exempt.

China New Substance Notification - Types of Notification

There are 4 types of notifications which depend on the use and volume of a new substance: scientific research record, simplified notification – special conditions, simplified notification – general conditions and regular notification.

The table below shows how to determine which type of notification is applicable.

China New Substance Notification - Data Requirements and Estimated Duration

Regular Notification	Four levels: 1-10t/y, 10-100t/y, 100-1000t/y, 1000t/y+; Minimum data requirement increases with tonnage band; Risk assessment report required for all levels; Estimated duration: level I(1 year), level II(2 years), level III(3 years), level IV(4 years.)
Simplified Notification – General Conditions	Minimum physio-chemical data: melting point, partition coefficient n-octanol/water and water solubility; 1 of the following 3 eco-toxicology studies must be conducted in China : ready biodegradability or acute toxicity study with Chinese fish or acute toxicity test with earthworms; Estimated duration: 4-8 months;
Simplified Notification – Special Conditions	No minimum data requirement; Simplified notification form and supporting document required; Estimated duration: 2-3 months;
Scientific Research Record	Test data not required; Only application form needs to be submitted; Estimated duration: 3-10 working days.

Mandatory Eco-toxicology Studies in China

For simplified notification under general conditions and regular notification, some eco-toxicology studies must be done locally in MEP-approved labs. The picture below shows which eco-toxicology studies must be conducted in China and the estimated duration of such studies in China.

Only Representative

Foreign companies may appoint a local Chinese agent to submit new chemical notifications on their behalf. China MEP Order 7 has set minimum requirement on the qualifications of a Chinese agent (for example, fixed office, minimum registered capital 3 million Yuan, etc.) The role of this agent is very similar to the role of "only representative" under EU REACH regulation. One big difference is that China MEP Order 7 allows traders to appoint Only Representatives while EU REACH only allows non-EU manufacturers to appoint Only Representatives.

Joint Submission

Joint submission of new substance notification under China MEP Order 7 is possible and not mandatory. However, if several registrants notify a new substance jointly or share test reports, their manufactured or imported amount should be added to determine the right level of notification.

Adding Notified New Substances onto IECSC

IECSC is not a static inventory. General new substances will be added onto IECSC by government notice 5 years since the date of the first commencement of manufacturing or importation. Whether hazardous new chemicals substances will be added onto IECSC depends on the review of technical committee. New substances that have gone through simplified notification or scientific research record cannot be added onto IECSC.

Post-notification Obligations

Getting a registration certificate is not the end. Certificate-holders have to fulfill post-notification obligations based on the category of management stated on the certificate.

New substances will be categorized as general new chemical substances or hazardous new chemical substances based on their hazard properties. Hazardous new chemical substances possessing persistent, bioaccumulative properties or are harmful to ecological environment and human health will be further classified as priority hazardous new chemical substances for environmental management and subject to additional post-notification requirements.

The picture below summarizes main post-notification obligations associated with different category of new substances.

- See more at: http://www.chemsafetypro.com/Topics/China/China_REACH_MEP_Order_7_New_Substance_Notification.html