Services

Our services

Ecotoxicological Centers have been providing professional consulting services to their clients for over 20 years. Our experts worked with numerous clients from different industries and therefore have a comprehensive knowledge and wide experience in dealing with regulatory issues.
The regulatory environment for the chemicals in Europe went through a lot of changes in recent years. While REACH implementation is the most important and complex the other regulations such as CLP and other dedicated to special product groups are being implemented constantly. We are here all the time keeping track of the changes and preparing full range of regulatory solutions for companies.
We offer consulting services tailor-made for your company.

Service

REACH and
CLP Compliance

REACH and CLP regulations are main legal acts that regulate the chemical’s market in the European Union. Each producer that want to be present on this market needs to meet the requirements of these legislation.

We offer a full range of REACH and CLP compliance service including:
  • Analysis for company’s obligations under REACH
  • Regulatory advice on the implications of CLP and REACH for your company;
  • Development of pre-registration documentation in REACH-IT
  • Registration - including substance identification, individual dossier development in IUCLID 6 and submission via REACH-IT, SIEF and ECHA communication and all other service needed
  • Representing your company as an Only Representative or Third Party Representative
  • Application for authorization
  • Performing the Chemical Safety Assessment for the substance and preparation of the Chemical Safety Report by the tools required by ECHA – ChESAR and IUCLID software.
  • Management of suppliers and downstream users relevant for your company and communication in the supply chain.
  • Management of articles in your company
  • Substance and mixture classification according to CLP regulation and Safety Data Sheet authoring
  • Label compliance check or design
  • Poison Center notification
  • C&L notification to ECHA
Only Representative service:
    • Submitting registration dossier to ECHA and represent your company in all communication with the Agency;
    • Applying for authorization of substances if needed
    • Representing your company in SIEF/Consortium and keeping you informed of the latest progress;
    • Safety Data Sheets authoring and supply in the supply chain;
    • Communication with EU importers and national regulatory authorities
    • Providing necessary documents to ensure REACH compliance;
    • Answering any enquiries and questions you may have as the REACH process continues;
    • Informing you of any new restrictions on substances and the consequences for your product;
    • Keeping an up-to-date list on the inventory of importers and the tonnage covered for each of these importers. This includes maintaining an archive for at least 10 years and providing data to enforcement authorities upon request
Third Party Representative service:
  • Protection of client’s identity and confidentiality
  • Representing your company in SIEF/Consortium and keeping you informed of the latest progress;
  • Participating in the identification and arrangements for studies to supply missing data
  • Providing necessary documents to ensure REACH compliance;
  • Answering any enquiries and questions you may have as the REACH process continues;
  • Informing you of any new restrictions on substances and the consequences for your product;
  • Submitting registration dossier to ECHA and representing your company in all communication with the Agency;

Service

SDS Authoring
and
maintenance

If your product is hazardous you have an obligation to provide your customer free of charge with the Safety Data Sheet in his national language. Once the SDS is created you need to update it whenever new safety information are available.

We offer you the both authoring and maintenance service for your SDSs:
  • Preparing REACH & CLP compliant, high quality SDS and e-SDS for majority of European countries
  • Providing relevant safety information about the product supported by professional software
  • Complex SDS management including keeping track of all regulatory changes that might affect the SDS of your product and making SDS revisions when necessary
  • Checking the correctness of the Safety Data Sheet you received from your suppliers
  • Full reporting of actions taken, results and recommendations for SDS

Service

Chemicals Management

Proper chemicals’ management in the company ensures full regulatory compliance of your products, safe use of the chemical substances, mixture and articles in the workplace and effective communication across the supply chain.

To achieve effective Chemicals Management in your company we offer you:1. SDSs screening - analyses of SDSs
  • Identification of chemical substances, mixture, products and articles used in company
  • Quality Assessment of SDSs including regulatory compliance and classification check and check of risk management measures
  • Development of a database of SDSs and suppliers
  • Quality Assessment of SDSs including regulatory compliance and classification check and check of risk management measures
2. REACH + CLP screening – identification of the company obligations in relation to REACH and CLP legislation
  • Identification of the activities, uses of chemicals and position of company in relation to REACH legislation and determination of the obligations for company
  • Categorization of chemical substances: SVHC, CMR substances, assessment of substance under CoRAP, chemical substance dangerous for the environment
  • Aalysis of responsibilities in the production and import of articles containing substances with a intended release or containing SVHC substances
  • Recommendation, proposal of solutions and procedures to be implemented.
3. Implementation of e-SDS obligations at workplace – scaling of the exposure scenario
  • Identification of the parameters from the Exposure Scenario of your supplier (conditions of use described by Use Descriptors, operational measures, control risks measures)
  • Defining the limit values for the substance under national legislation
  • Comparison of operating conditions and of use of personal protective equipment (PPE) in your company to the conditions and PPE proposed by the manufacturers in the e-SDS
  • Checking the compliance of operations
4. Active communication in downstream supply chains
  • Ensuring communication with suppliers to correct the failings identified in the SDS
  • Representing the company in relation to suppliers as the exclusive body for communication with suppliers.
  • Developing a database of SDSs and suppliers
5. Workplace safety and environmental protection – operational procedures and risk assessment
  • Risk Assessment
  • Information on location of workplace where the hazardous chemical agents occur
  • Safety work practices and technology procedures
  • The protection and preventive measures to eliminate or reduce risk, including technical control systems to prevent the release of hazardous chemical factors, the ignition or explosion
  • Emergency plan
  • Instructions and equipment for first aid
  • Method and frequency of training

 


 

Service

Importers to EÚ

  Industry — producers, importers of mixtures, articles, and importers of substances as well as downstream users. Importers to European Union have specific obligations under REACH regulation, specific sectors regulations and general product legislation; in particular, the registration of substances on their own, in mixtures and substances intended to be released from articles and the communication/ notification to the European Chemical Agency of SVHC present in the article...

CHEMICALS MANAGEMENT IMPORT — Only Representative, SUPPLY CHAIN COMMUNICATION, ARTICLES...

  Ekotox Centers helps you to comply with the legislative requirements as well as customers demands for tasks undertaken in the import to European Union involving the representation as Only Representative, registration, notification, handling of documentation concerning chemicals and mixtures, components, spare parts and articles.

Critical areas are:
  • understanding and communicating “chemical” issues in the supply chain (Registration dossiers, SDS, eSDS, exposure scenarios);
  • control of SVHCs in “articles”;
  • handling and use of chemicals;
  • implementing practical “manageable” solutions.
„Chemicals“legislation (REACH, CLP, Stockholm Convention, WEEE, ROHS...) have significant implications for the European companies and importers. It is evident now that the whole supply chain is impacted and there is a lots of tasks needed to achieve compliance. These complex regulations require systematic approach to:
  1. Understand
  2. Communicate
  3. Organize
  4. Plan
  5. Register

- because REACH Registration — ! No Data No Market ! Companies that do not comply with REACH will have no market in the EEA. REACH poses a threat to any company doing business in the EEA (and businesses with customers or suppliers who do business in the EEA).

Authorisation — ! Substances of Very High Concern (SVHC) ! SVHC's will have strict controls applied to their use. Ultimately SVHC's will be removed from all supply chains, so close attention needs to be paid to their presence and monitoring of their use in advance of their disappearance. There may be several hundred SVHC's announced by the EU Member States or the European Commission in the coming few years, so their impact will be far reaching.

Data Sharing - ! Communication in a supply chain ! New data availability have an impact to complexity of hazard and risk information communicated via safety data sheets and exposure scenarios. New limit values and risk control measures need to be understood and respected.

WE CAN HELP YOU — Assistance / Training / Outsourcing

Chem Screening - basic analysis of the satus, duties and requirements based on data provided by the customer; targeted compliance check; REACH audit - detail analysis of the processes and procedures for chemicals legislation compliance; REACH-readiness of company itself and suppliers; customers — suppliers information collection and storage; internal management of chemicals, mixtures and articles; health and environmental implications of REACH documentation; Supply Chain Analysis - suppliers status of practices in providing information — quality and reliability of SDSs; communication practices; REACH-readiness;

Contact us now to get more information

 


 

Service

Chemical Safety Report
and
Exposure Scenario

A manufacturer or importer of a substance in quantities of 10 tonnes or more per year needs to prepare a chemical safety assessment (CSA) and needs to document this assessment in his chemical safety report (CSR) as part of his registration dossier. The output of the CSA will be exposure scenarios with operational conditions and risk management measures for adequate risk control. Exposure scenarios have to be communicated to the downstream users as annexes to the Safety Data Sheets.

We offer you the service including:
  • Performing the Chemical Safety Assessment for the substance and preparation of the Chemical Safety Report with the tools required by ECHA – ChESAR and IUCLID software.
  • Development of exposure scenarios for all uses
Chemical Safety Assessment includes the following steps:
  • human health assessment
  • physicochemical hazard assessment
  • environmental hazard assessment
  • Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) assessment (or substances of similar concern)
If the substance meets the criteria for classification as dangerous, or meets the PBT/vPvB criteria, the CSA shall also include:
  • An exposure assessment for all identified and relevant uses of the substance and resulting life cycle steps, including the generation of exposure scenario(s)
  • A risk characterization which is the final step in the chemical safety assessment. The risk characterisation identifies if the risks arising from manufacture/import and uses of a substance are adequately controlled.

Service

Biocidal products

Biocides are highly regulated products that need to be authorized prior placing on the market. Depending on the active substance the authorization can be granted by European or National procedure. For national procedure the requirements are different in different EU countries. All that makes the whole process really complex and time-consuming.

We offer a comprehensive consulting service regarding biocidal products registration and assistance through the whole process:
  • Consultation of the registration strategy on particular European markets, choosing the proper registration procedure taking into account the active substance and product type
  • Preparation of all documents required for registration of a biocidal product and placing them on the market: biocidal product entry in the Register, Safety Data Sheet, text part of the label, instructions for use, if not stated on the label
  • Application for authorization of biocidal products at local authorities or
  • Set up of R4BP account and submission of the dossier
  • Preparation of data sharing inquiries
  • Applications for technical equivalence assessment or chemical similarity check
  • Application for inclusion in the art. 95 suppliers’ of active substance list
  • In cooperation with GLP laboratories we offer also laboratory services for testing of active substance in biocidal products.

AUTHORISATION

BIOCIDAL PRODUCT FAMILIES


Service

Cosmetics

Cosmetic products are regulated at European level to ensure consumer safety and to secure an internal market for cosmetics. New Regulation on cosmetic products (EU Regulation 1223/2009) unifies the requirements for cosmetic products in all Member States. All products to be marketed in the EU must have product information file and be notified in the Cosmetic Products Notification Portal before being placed on the market.

We offer you the elaboration of product information file (PIF) and the notification of your product - via the EU Cosmetic Products Notification Portal (CPNP), consultation and preparation of all documents required for placing of a cosmetic product on the EU market.

Placing of cosmetic product on the EU market

Article 11 of Regulation (EC) No 1223/2009 requires that a product information file is drawn up for each product before it is placed on the market. The product information file should be updated when necessary and kept readily accessible, in electronic or other format, at the address of the responsible person given on the label, to the competent authorities for market surveillance purposes for a period of 10 years following the placing on the market of the last batch of the product.

As per Article 13(1) of Regulation (EC) No 1223/2009, prior to placing on the EU market the cosmetic product shall be notified in the EU portal CPNP.

Notification is performed, when the documentation is complete.

Cosmetic Product Safety Report

Cosmetic product safety report (CPSR) is intended to gather the data necessary to prove that the cosmetic product is safe. The information should enable the safety assessor to clearly identify and quantify, based on the identified hazards, the risks a cosmetic product may present to human health. A hazard may arise, for example, from the raw materials, the manufacturing process, the packaging, the conditions of use of the product, the microbiological specifications, the quantities used, the toxicological profile of the substances, etc.

For working-out of the CPSR we will need following information:

  1. the complete composition of cosmetic product (names of individual components according to INCI, their CAS or EINECS numbers, their amounts (%) in the product and their function) and if available the safety data sheets  for each component
  2. physical and chemical properties of the cosmetic product (e.g. physical form, pH, odor, density ... )
  3. microbiological properties of the product (total viable count for aerobic mesophyllic microorganisms, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans)
  4. results of challenge test
  5. stability of the cosmetic product under reasonably foreseeable storage conditions (minimum durability/period-after-opening) – results of stability study
  6. information about the packaging - material used and its characteristics (composition, stability, purity...)
  7. use of the product,  directions for use (information relating to the site(s) of application, the surface area of application, the amount of product applied, the duration and frequency of use, normal and reasonably foreseeable exposure route(s), the targeted population)
  8. undesirable effects of the product
  9. other relevant information, e.g. existing studies from human volunteers

For some product types, not all microbial tests are required. We will provide more detailed information after sending the documentation.

CPSR is worked-out in English language in the specified format for entry to the entire EU market.

The report also includes the working-out of mandatory particulars which must appear on the label in the language of the Member State concerned.

In case of interest, please contact us via the ekotox(at)ekotox.sk

Cosmetic Products Notification Portal (CPNP)

The Responsible Person will have to notify each cosmetic product to the Commission via a database that is ready for use.

The Commission then makes this information available to the competent authorities and poison centres or similar bodies within each Member State.

It is important to note that the fact that a product has been successfully notified through CPNP does not necessarily mean that the product in question fulfills all the requirements of the Regulation (EC) N° 1223/2009 of the European Parliament and of the Council on cosmetic products.

For notification of cosmetic product we will need following information:

  1. Category of cosmetic product and name(s) by which it is identified
  2. Country of origin (where imported into the EEA)
  3. Member State in which it will be placed on the market
  4. Contact details of a physical person to be contacted if necessary
  5. Frame formulation (only provided to poison centres or similar bodies)
  6. Original labelling and, where possible, a photograph of the packaging

In case of distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, we will need following information:

  1. The category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification
  2. The Member State in which the cosmetic product is made available
  3. Contact details of distributor
  4. Contact details of the responsible person where the product information file is made readily accessible

In case of interest, please contact us via the ekotox(at)ekotox.sk

Preliminary Assessment of the cosmetic product

We offer you  consultation and technical support when formulating the recipe for its suitability according to the requirements of the EU legislation, SCCS (Scientific Committee on Consumer Safety), CIR (Cosmetic Ingredient Review), ECHA (European Chemicals Agency) recommendations and/or the information from other scientific literature.

The Preliminary Assessment does not meet the requirements of Cosmetic Product Safety Report according to Regulation (EC) No 1223/2009 of the European parliament and of the Council of 30 November 2009 on cosmetic products.

This report could be used solely for ingredients assessment and in case that cosmetic products are entering the EU market, full Cosmetic Product Safety Report is needed.

For working-out of the preliminary assessment we will need following information:

1) the complete composition of cosmetic product (names of individual components according to INCI, their CAS or EINECS numbers, their amounts (%) in the product and their function) and if available the safety data sheets  for each component

In case of interest, please contact us via the ekotox(at)ekotox.sk

Product claims

According to Regulation (EC) No 1223/2009 in the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

The European Commission has adopted Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products:

1) Legal compliance

2) Truthfulness

3) Evidential support

4) Honesty

5) Fairness

6) Informed decision-making

We offer you working-out of the product claims according to the Regulation (EC) No 1223/2009 and the Regulation (EU) No 655/2013.

In case of interest, please contact us via the ekotox(at)ekotox.sk

 


Service

Poison Center Notification

The obligation to collect the data about hazardous mixtures placed on the market arises from the article 45 of CLP. Each Member State has its own procedures of data submission and different competent authority.

We offer a full end-to-end notification service across all European Countries:
  • Choosing the data needed for submission
  • Communicating with national competent authorities
  • Setting up the company accounts in electronic systems where necessary

Service

Articles under REACH

Producers of articles also might have responsibilities under REACH. As articles are ‘objects which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition’ the impact of REACH regulation is very wide and on many industries.

We offer you the full compliance check and advisory for the articles you produce:
  • Help to define and fulfil your duties as an article producer
  • Registering substances from articles with an intentional release
  • Fulfilling the requirements for articles containing substances from the Candidate list
  • Special attention given to toys and e-cigarettes

Service

ELECTRONIC CIGARETTES

Manufacturer and importer placed on the market tobacco products, electronic cigarettes and related products has to fulfill requirements under DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC.

Manufacturer and importer have to fulfill the following requirements:
  • register a tobacco products
  • prepare a Safety Data Sheet (SDS)
  • label a tobacco products accordingly

We offer preparation of all documents required for registration of a tobacco products, electronic cigarette and herbal products for smoking and placing them on the market:

Setting up an ECAS account and registering for submitter identification number (ID) in the EU-CEG
  • Filling in the registration form for the ingredient of product by use the TPD XML creator tool and create documentation for the ingredient(s)
  • Filling in the registration form for the product by use the TPD XML creator tool and create documentation for the product(s)
  • Safety Data Sheet (SDS)
  • Text part of the label