Q1: What is REACh Regulation?

Our current chemical system consists of more than 103,800 chemical substances. Round about 100,000 of these were introduced to the market before 1981 and are listed as "existing chemicals" or "phase-in substances" in EINECS (European Inventory of Existing Commercial Chemical Substances). The rest - more than 3,800 substances - are listed as "new chemicals" in ELINCS (European List of Notified Chemical Substances). For the existing chemicals, which cover more than 97% of the market, there is a lack of information regarding their safety for human health and the environment.

With REACh Regulation, this gap is closed. It is the new chemical regulation of the European Parliament and the Council of the European Union, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.

REACh Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or this site use such substances that do not adversely affect human health or the environment.

In detail, REACh will: 

  • improve the protection of human health and the environment,
  • ensure transparency throughout the whole chemical supply chain,
  • transfer responsibility from public authorities to the whole chemical industry (manufacturers, importers and downstream users),
  • create a harmonised system for EINECS and ELINCS,
  • substitute hazardous substances,
  • promote non-animal testing

Q2: What is the REACh timeline?

The REACh regulation already came into force on 1 June 2007. Pre-Registration could be done from 1 June 2008 until 1 December 2008 to make use of the transition periods related to the registration deadlines for the different tonnage bands. Meanwhile the first and second deadlines (1 December 2010 and 31 May 2013) have passed and the challenge is now to register the substances in the tonnage band below 100 t/a until 31 May 2018.

Q3: What are the REACh obligations?

If you are

  • a manufacturer: any natural or legal person established within the Community who manufactures a substance within the Community, and/or
  • an importer: any natural or legal person established within the Community who is responsible for import, and/or
  • a downstream user: any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user,

then REACh Regulation affects you. If you fail to register, the consequences are serious. To cialisvsviagracomparison.com/ summarize Article 5: "No data, no market".

Any manufacturer or importer of a substance, on its own or in mixtures, in quantities of one ton or more per year has to submit a registration to the Agency. Any manufacturer or importer of polymers has to register the monomer substances. In cases where substances/mixtures/monomers are produced or imported in quantities of ten tons or more per year, the manufacturers or importers have to conduct a chemical safety assessment (CSA) and to create a chemical safety report (CSR). If manufacturers/importers are producing/importing hazardous substances/mixtures, the manufacturers/importers additionally have to create an exposure scenario (ES). To ensure the safe use of chemical substances/mixtures, downstream users are obliged to inform the producer/importer about the application and working conditions, so that the manufacturer/importer can create an individual chemical safety report or respective risk management measures.

As a non-Community manufacturer you cannot register your substances (on their own, in mixtures or in articles) directly. You need a legal entity within the European Community or have to appoint a natural or legal person as your "REACh Only Representative" (Article 8) to fulfil your obligations. The advantage of a "REACh Only Representative" is the higher protection of sensitive information and thus better control of your know-how. In addition you can profit from an anonymous appearance in SIEF and consortia. As an EU manufacturer or EU importer you can also appoint a fully responsible "third-party representative" to comply with your obligations under REACh.

Q4: What is a REACh Only Representative?

Non-European companies are not allowed to pre-register or register substances under REACh Regulation, to maintain and continue the business within the EU, a Non-European producer has the option of appointing a REACh Only Representative.

Using the REACh Only Representative the Non-EU Manufacturer of Chemicals will join a third independent partner, who protects the know-how, confidential business information and offers a neutral position in SIEF & consortia.

The selection of a REACh Only Representative has to be done very carefully.

The REACh Only Representative has to fulfil the requirement under REACH, namely he shall have sufficient background in the practical handling of substances and the information related to them.

Furthermore the REACh Only Representative should offer a confidentiality agreement and the liabilities have to be clarified and ensured.

Q5: What are the advantages to appoint a REACh Only Representative?

The most important advantages, why to appoint an Only Representative for REACh (usually designated as OR) are:

  • to avoid that an importer simply forget the pre-registration for one or more substance/s
  • in case of many importers the non-European manufacturer has the advantage to reduce his work & communication, otherwise he has to pass all necessary information to every importer and to communicate with each of them regarding all matters in accordance to REACh
  • the appointed REACh Only Representative is neutral, no active actor of the supply chain and offers the non-European manufacturer a high protection of know-how 
  • to avoid that the importers meet each other in SIEFs and communicate about prices, quantities etc.
  • to avoid that importers meet the competitors of the non-European manufacturer 
  • concentration on core business (for importers & non-European manufacturer) 
  • to profit from synergy effects (registration of many products = savings)

Q6: What is CLP Regulation?

The CLP Regulation, concerning the Classification, Labelling and Packaging of substances and mixtures, entered into force on 20 January 2009. It concerns to the implementation in the EU of the rules established in the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). It replaces Directive 67/548/EEC (Dangerous Substances Directive) and Directive 1999/45/EC (Dangerous Preparations Directive). 

This Regulation, not less complex than REACh, will ensure a high level of protection of the human health and the environment as well as the free movement of substances and mixtures due to the use of a recognized worldwide classification and labelling system based on the GHS. 

CLP Regulation will have significant impact on Manufacturers (M), Importers (I) and Downstream Users (DU) that will need to classify and label their substances, mixtures and also certain articles, http://tadalafilcialisindia.com/ according to the rules of this new Regulation. Companies will have a big challenge also with SDS authoring and IT systems, training and, if necessary, testing physicochemical properties. It’s important not to forget that GHS will be updated every two years and CLP will need to reflect the changes imposed by the UN. 

In detail, CLP will:

  • improve the protection of human health and the environment
  • create an harmonized criteria for the classification of substances and mixtures as well as rules regarding labelling and packaging for hazardous substances and mixtures
  • establish a list of substances with harmonized classifications and labelling (Annex VI)
  • create a classification and labelling inventory of substances notified by M/I
  • substitute the Dangerous Substances and Preparations Directives
  • improve worldwide market access for the EU companies

Q7: What is the CLP timeline?

The CLP Regulation already came into force on 20 January 2009. It establishes several transitional periods between 2010 and 2017 for the classification, labelling and packaging of substances and mixtures. The update of Safety Data Sheets according to the Regulation (EU) No 453/2010 also benefits from a transition period. Meanwhile, the first deadline 1 December 2010 to re-classify substances according to the CLP has passed as well as the second deadline to to re-classify mixtures (June 2015). The date 3 January 2011 was the first deadline for Manufacturers (M) and Importers (I) notify the Classification & Labelling of certain substances to the ECHA Inventory. From this date beyond, M/I will need to notify to the Classification & Labelling Inventory within 30 days of placing the substance on the EU market.

Q8: What are the CLP obligations?

If you are 

  • a manufacturer: any natural or legal person established within the Community who manufactures a substance within the Community, and/or
  • an importer: any natural or legal person established within the Community who is responsible for import, and/or
  • a downstream user (including formulator/re-importer): any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006; and/or
  • a distributor (including retailer): any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties
  • a producer of articles: any natural or legal person who makes or assembles an article within the Community,

then CLP Regulation affects you. 

Unlike REACh Regulation, CLP applies to substances independently of the yearly tonnage band. Some substances like Biocides which are exempt from the REACh regulation, are now under the scope of CLP. Also the Research and Development of chemicals may have obligations within CLP regarding classification, labelling, packaging and notification. The update of Safety Data Sheets (SDS) with the CLP Classification and Labelling is also a very important obligation for Manufacturers and Importers. Besides the label, SDS are the most important hazard communication document.

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In summary, the main obligations under CLP are:

  • classification, labelling and packaging of substances and mixtures according to the CLP before placing them on the market
  • classification of substances not placed on the market but that are subject to registration or notification
  • notification of the classification and labelling elements to the classification and labelling inventory established at the Agency (ECHA) in case of placing substances on the market
  • updating the label following any change to the classification and labelling of that substance or mixture, in certain cases without undue delay
  • submitting a proposal to the Competent Authority in one of the Member States in which the substance is placed on the market in case of new information which may lead to a change of the harmonised classification and labelling elements of a substance
  • keeping available all the information required for the purposes of classification and labelling under CLP for a period of at least 10 years after the last supply of a substance or mixture (this information should be kept together with the information required in Article 36 of REACH)
  • taking all reasonable steps available to be aware of new scientific or technical information that may affect the classification of the substances or mixtures placed on the market and when becoming aware of such information considered to be adequate and reliable, a new evaluation of the relevant classification should be done without undue delay
  • classification, labelling and packaging explosive articles according to the CLP before placing them on the market, apart from the obligation to notify the Agency
  • classification of substances not placed on the market that are subject to registration or notification in case of produced or imported articles.

 

Q9. What is the Biocidal Products Regulation?

The Biocidal Products Regulation (BPR), concerning the making available on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, applies from 1 September 2013, with a transitional period for certain provisions. Regulation (EU) No 528/2012 (BPR) replaces the Biocidal Products Directive 98/8/EC (BPD). The purpose of this Regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. 

Like in REACh and CLP, ECHA is the focal point for all processes under the Biocidal Products Regulation. 

The Biocidal Products Regulation applies to biocidal products and treated articles. A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V. Disinfectants, wood preservatives, insecticides and other pest control products are some examples of biocidal products. 

The BPR lays down rules for: 

  • the establishment at Union level of a list of active substances which may be used in biocidal products;
  • the authorisation of biocidal products;
  • the mutual recognition of authorisations within the Union; 
  • the making available on the market and the use of biocidal products within one or more Member States or the Union; 
  • the placing on the market of treated articles.

Q10. What is the Biocidal Products Regulation timeline?

The Biocidal Products Regulation already came into application on 1 September 2013 and establishes several timelines. 

For the approval of new active substances:

  • After the validation check has been performed by ECHA, the evaluating competent authority carries out a completeness check and an evaluation within one year.
  • The result of the evaluation is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days.
  • The approval of an active substance is granted for a defined number of years, not exceeding ten years.
  • For the renewal of the approval of an active substance, the application to ECHA has to be submitted 550 days before the expiry date of the approval.

Existing active substances:

  • From 1 January 2014, the ECHA took over the coordination of the review programme that was set up under the previous Biocidal Products Directive and continues now under the Biocidal Products Regulation.

For the Authorisation of Biocidal Products:

  • National authorisation: the Member State competent authority evaluates the application and makes a decision on the authorisation within 365 days.
  • Mutual recognition: the process will take approximately five months from the validation of the application by the evaluating competent authority.
  • Union authorisation: can be granted to biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and those belonging to product-types 14, 15, 17, 20 and 21. The timeframe for initiating the authorisation process is different depending on whether the product contains new or existing active substances. A product containing new active substances, also in combination with existing active substances, is eligible for Union authorisation from 1 September 2013. For biocidal products containing only existing active substances, Union authorisation will be available in three different stages, depending on the product-type: 
    • From 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19 
    • From 1 January 2017 for product-types 2, 6 and 13 
    • From 1 January 2020 onwards to the remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22. 
    • Simplified authorisation: the biocidal product may be made available on the market in other Member States without the need for mutual recognition. The authorisation holder needs to notify each relevant Member State 30 days before placing the product on its territory.
  • Product family: if the composition of a new product falls within these established ranges an authorisation holder only needs to notify the product to the authorities 30 days before placing the new product on the market.

Approved Suppliers:

  • From 1 September 2015, a biocidal product cannot be placed on the EU market if the manufacturer or importer of the active substances contained in the biocidal product, or the importer of the biocidal product, is not included in the list of active substance suppliers.

Treated Articles:

  • BPR allows for treated articles that were available on the market on 1 September 2013 to continue to be placed on the market until the date of a decision concerning the approval for the relevant product-type of the active substance(s). The application for the approval of the active substance(s) for the relevant product-type needs to be submitted to the ECHA at the latest by 1 September 2016.
  • Anyone placing a treated article on the market must provide, free of charge when requested, information on the biocidal treatment of the treated article. This information must be provided within 45 days.

 

Q11. What are the Biocidal Product Regulation obligations?

If you are 

  • a manufacturer of active substances or biocidal products
  • an importer of active substances or biocidal products
  • a distributor of active substances or biocidal products
  • a producer of articles treated with bocides

then the Biocidal Products Regularion affects you. 

All biocidal products must get an authorisation before they can be placed on the market with a previous approval of the active substances contained in that product. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it: National authorisation, Mutual recognition, Union authorisation or Simplified authorisation. 

If your active substance has been through the assessment process and has already been approved (in the Union List) under the Biocidal Products Regulation for the relevant Product Type for your product, then you will need to get your product authorised before placing it on the market. 

If your active substance is still undergoing review for your Product Type, then products can be brought to the market without needing to be Authorised under the Biocidal Products Regulation, however, once the review of the Active is completed you will need to seek Authorisation for the product or remove it from the market. While the review is on-going, products still need to comply where necessary with the requirements of other relevant national legislation and also to some specific elements of the Biocidal Products Regulation. 

The IT platform, the Register for Biocidal Products (R4BP), will be used for submitting applications, exchanging data and information between the applicant, ECHA, Member State competent authorities and the European Commission. Another IT tool, also used mainly under REACh Regulation but also for Classification & Labelling Notifications under CLP Regulation, the IUCLID 5, will be used for preparing the dossiers. 

The Biocidal bactrimsale.com Products Regulation also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods. 

It is necessary that the active substances used in a biocidal product are technically equivalent to approved ones. The ECHA will assess the technical equivalence if: the manufacturer is different from the one holding the original approval, the manufacturing process is different, the manufacturing location of the approved manufacturer has changed. 

To ensure that the costs are equally shared, all active substance manufacturers or importers must submit a letter of access or a full dossier to ECHA for each active substance they sell or use in biocidal products. ECHA will publish and maintain a list of all companies and active substances meeting this obligation. Only the biocidal products containing the particular active substance from companies on the list are allowed to remain on the market after 1 September 2015. 

Under the Biocidal Products Regulation, articles can only be treated with biocidal products containing approved active substances. Treated articles must be appropriately labelled according to the Biocidal Products Regulation and the regulation on Classification, Labelling and Packaging of substances and mixtures (CLP).

 

Q12. What is an EU Representative for Biocidal Products Regulation Art. 95?

The aim of Article 95 of the EU Biocidal Products Regulation is to ensure that all players contribute to the costs of the active substance approval process during the period when they make the active substance available on the market.

Inclusion on the ECHA Article 95 list is key for biocidal products to remain on the market after 1 September 2015. Applications for inclusion in the list of active substances suppliers (Article 95 list) can only be made by a person established within the EU. However, non-EU companies can be represented by an EU representative, for the purpose of Article 95, and be indicated on the list next to their EU representative.

 

Q13. Some next FAQ

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