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Frequently Asked Questions of REACH regulation
 
1.         What is the definition of Small and Medium Enterprises (SMEs) in REACH regulation? How much is the registration fee for SMEs?
 
According to REACH regulation, the definition of Small and Medium Enterprises (SMEs) are:
1. The total number of employees of an SME must be less than 250 AND,
2. The annual profit of an SME has to be less than 50 million euro AND,
3. The total debt of an SME has to be less than 43 million euro.
Normally, substance pre-registration is totally free of charge. According to an official document from ECHA estimate the registration fee for a single substance with less than 10tpa import volume is 1600 euro. On the other hand, the registration fee for a single substance who import to EU more than 1000tpa is 3100 euro. Apart from that, ECHA will provide 30%-60% discount to SMEs (depends on the size of SME) in order to encourage registration.
 
 
2.         How to evaluate the need of pre-registration/registration?
 
The best method to check whether you should pre-register/register for your exporting substances/articles is prepare comprehensive information of your product such as production processes, substance properties and safety assessment, etc. However, this method takes a very long time and usually huge cost is needed, which is normally unaffordable for SMEs. On the other hand, you may also answer two simple questions for preliminary checking:
 
1.    Are there any substances that are intended to be released from the produced or imported article(s) during normal and reasonable foreseeable conditions of use? (e.g. Ink of a pen is an intended release substance) AND,
2.     Is the total amount of the substance present in the articles with intended releases produced and/or imported by that actor exceeds 1 tonne per year per producer or importer?
 
If both answers are YES, you should pre-register/register this substance ASAP.
 
 
3.         What are the benefits of Pre-registration?
 
Enterprises who completed pre-registration can share the testing data and information of the pre-registered substance with other pre-registrants. And successful pre-registrant can simplify the process and data input in the registration, thus cost can be saved. In addition, successful pre-registrants can keep exporting products to EU countries within the official deadline, to maintain the EU market.
 
 
4.         What information is needed for pre-registration?
 
For every single pre-register substance, should be provided with following information:
  • Substance Name (IUPAC, EINCES or CAS number, etc.)
  • Name and address of the registrant
  • Estimated volume of exporting per year and its registration deadline
  • Other related substance information
  
5.         What are the meanings of the abbreviations in REACH regulation?
 
Common abbreviations in REACH regulation
ECHA - European Chemical Agency
CSR - Chemical Safety Report
C&L - Classification and labelling
ES - Exposure Scenario
DU - Downstream User
SDS - Safety Data Sheet
OSOR - One Substance, One registration
PPORD - Product and Process Oriented Research and Development
CMR - Carcinogenic, mutagenic or toxic for reproduction  
PBT - Persistent Bioaccumulative and Toxic
SIEF - Substance Information Exchange Forum
vPvB - very Persistent, very Bioaccumulative
OR - Only Representatives
RIPs - REACH Implementation Projects
 
 
6.         What substances/products are exempted from REACH?
 
Substances/products that are exempted from REACH include:
1. Radio-active substances
2. Substances under customs supervision
3. Non isolated intermediates
4. Wastes
5. Polymers
6. Substances use for purpose of product and process oriented research and development (PPORD)
7. Substances that considered as very low harm to human body and environment (Annex IV)
8. Natural substances
9. Corn oil
10. Nitrogen
 

Substances/products that are exempted from registration include:
1. Medicinal products
2. Basic elemental substances for which hazards and risks are already well known (Water, Oxygen)
3. Specific types of cellulose pulp
4. Natural substances
5. Polymers
 
 
 
7.         Registration for preparation/article which contains a number of substances
 
According to REACH regulation, ECHA requires EU manufacturers and importers to register each substance in a preparation with annual tonnage over 1 tonne. On the other hand, for article, manufacturer/importer have to register each substance in an article which classified as intended to be released during normal and reasonable foreseeable conditions of use AND, the total amount of this substance present in the articles exceeds 1 tonne per year. Normally, enterprise can reference to the original Chemical Safety Report (CSR) or Material Safety Data Sheet (MSDS) of this substance for the registration process.
 
 
8.         What is the function of Substance Information Exchange Forum (SIEF)?
 
REACH provides for the formation of SIEFs to share data among Manufacturers and importers of pre-registered phase-in substances, phase-in substances registered without pre-registration, holders of information on phase-in substances that are used as plant protection products and biocides as well as allowing Downstream Users and other stakeholders (Data Holders) who have, and are willing to share, relevant information to sell their information to potential registrants. A SIEF will be formed for each pre-registered substance with the same chemical identity. The participants in the SIEF will essentially be the Potential Registrants and the Data Holders (including early registrants).

The aims of the SIEF are to: 
  • Facilitate data sharing for the purposes of Registration, thereby avoiding the duplication of studies, and 
  • Agree on the classification and labelling of the substances concerned where there is a difference in the classification and labelling of the substance between the Potential Registrants.
Participants in a SIEF are free to organize themselves as they see fit to carry out their obligations under REACH, i.e. to share data, especially those involving vertebrate animal testing.
 
 
9.         What is joint submission?
 
Each manufacturer, importer or only representative is individually obliged to submit a registration for each of his substances. However in cases where a substance is manufactured or imported by more than one company, they are required to submit certain information together. This is called the joint submission of data. Registrants are required to jointly submit information on the hazardous properties of the substance and its classification and labelling and a testing proposal (if any), and can, if they agree, also jointly submit the chemical safety report and guidance on safe use. The intention is that registrants will save money by co-operating on the preparation of the dossier and to reduce the need for testing, in particular on vertebrate animals.
 
 
10.     About Non-EU registrants 
 
According to REACH regulation, non-EU enterprises cannot register directly to ECHA; therefore non-EU enterprises can only appoint an Only Representatives (OR) to represent them for pre-registration/registration process completion, and your employed OR will also responsible to communicate with other pre-registrants in SIEF, thus complete the joint submission process.
 
       
11.     What is Substance of Very High Concern (SVHC)?
 
Substances that are included in the Candidate List have been identified as Substances of Very High Concern (SVHC). These substances may have very serious and often irreversible effects on humans and the environment. Substances on the Candidate List may subsequently become subject to authorization by decision of the European Commission.
 
 
12.     Where can I check the latest SHVC candidate list and related updates?
 
Until March 2009, 15 substances are classified as SVHC, include:



For more information please refer to this link:
http://www.echa.europa.eu/chem_data/candidate_list_table_en.asp


13.     Do I need to count the packaging materials when calculate the total volume of an article?
 
It depends, if the product you sell in the market is kept in packaging, means the end user can touch the packing materials, thus the packaging materials should be counted; on the other hand, if there’s no packaging exist when the end user buy the product, the packaging material should not be counted.

 
14.     How many pre-registrants/substances completed its pre-registration process? Where can I find the related updates?
 
Until 1/12/2008, recorded that there are in total 65,655 enterprises completed the pre-registration process, and the number of completed pre-registration is around 2,212,129. Over 100,000 of them are chemical substance. The full list of pre-registered substance is already released in 1/1/2009, which can be access in this link:
http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx

 
15.     Regardless to my business nature, what steps do I need to proceed in order to comply with REACH regulation?
Enquirers:
- a local garment manufacturer on 13 April
- a company from printing industry on 24 April
- a mirror producer on 1 May
 
Step 1:
Contact your material suppliers to obtain a full “Bill of Substances” (BOS). If your suppliers cannot provide the full list, you need to seek assistance from testing laboratories.

Step 2:
Check the BOS and find if there are any intended release substances from the produced or imported article(s) during normal and reasonable foreseeable conditions of use.
 
Step 3:
If you find any intended release substances, check the tonnage level of the substance. If the annual tonnage exceeds 1 tonne, you have to appoint an Only Representative (OR) representing you to register this substance.
 
Step 4:
Check the BOS again and identify if there are any substances classified as Substance of Very High Concern (SVHC) were used in the product or its production processes. Please refer to question 12 for the SVHC candidate list up to May 2009.
 
Step 5:
If any substance classified as SVHC was used in your product or its production processes, you have to communicate with your supply chain parties and clients immediately and ask your OR for the notification process before December 2010.