Chemical Management Services

Under the motto ” No data, no market ”, REACH Regulation no. 1907/2006 imposes on the manufacturers / distributors / users of chemicals a series of compliance requirements before entering the market with the chemical, the most important being the registration with ECHA (European Chemicals Agency).

I offer you complete solutions in order to comply with REACH requirements, to draw up the registration file and to send it to ECHA:

Identification of obligations and requirements for compliance with the provisions of the REACH Regulation;
Analysis of the chemical product in the context of placing on the market in Romania and in the intra-community area, registration, authorization and restriction requirements;
Support in communication on the supply chain, with upstream suppliers and downstream users
Identification of obligations applicable to products imported from outside the Community area;
Facilitating registration in SIEF (Forum for information exchange), Consortia
European REACH,facilitate the purchase of REACH Letter of Access;
Calculation of fees and royalties applicable to the REACH registration procedure, according to Reg. (EU) 895/2018 and which will be paid to ECHA
Registration of the company on the REACH -IT portal through which the REACH dossiers will be uploaded’’
Preparation of REACH dossiers and transmission to ECHA – products manufactured / imported in quantities> of 1 ton / year,> 100 tons / year,> 1000 tons / year
IUCLID6 software use – database used for the elaboration of chemical registration dossiers, according to Reg. (EC) no 1907/2006 – REACH
How to use REACH –IT platform in order to REACH registration the chemicals
Support for REACH authorization of a chemical product (SVHC checklist, implementation deadlines, applicable legislation, cost estimation);

Product registration consultancy REACH compliant: 2300 Euro*

BPR – European Regulation no. 528/2012 regarding the placing on the market and the use of biocidal products.

I offer support for national approval of biocidal products for all groups: Group 1 – Disinfectants, Group 2 – Preservatives, Group 3 – Pest control products, Group 4 – Other biocidal products

Introducing and placing chemicals on the Romanian market – products manufactured internally or purchased from within the community;
Preparing the technical files for the approval of biocidal products for placing on the market;
Preparation of the file in order to obtain the extension of the domain, the application area, the packaging for a product that has a marketing approval – minor / major changes
Support for contracting biocidal efficacy tests for the product to be approved as biocidal
Support during the conduct of the approval procedure by the National Biocides Commission, until obtaining the biocide approval

I offer support for the European Authorization of the biocidal product

Identification of biocidal product eligible for European authorization
Identification of the type of authorization applicable to the biocidal product: union, national, mutual recognition in parallel, successive recognition, simplified authorization
Activities prior to the authorization: company registration in the ECHA list – Art. 95; elaboration of biocidal file according to Art. 54 – Technical equivalence
Facilitating company registration in European Biocide Consortia / Groups in order to gain access to the common technical file
Calculation of fees and royalties applicable to the authorization procedure according to Reg. 564/2013 and which will be paid to ECHA according to Reg. (EU) no. 528/2012 of biocide
Authorization file elaboration in IUCLID 6 format
Registration of the company in the European R4BP Register of Biocides
Development of SPC file (biocidal product characteristics)
Elaboration of supporting documents according to the European biocidal authorization procedure
Submitting the biocidal authorization application through the R4BP register

Approval, authorization of biocidal products consultancy: 1500 euro*

CLP – European Regulation no. 1272/2008 regarding the classification, labeling and packaging of substances and mixtures.

You cannot place a chemical on the market without a suitable, correct, complete, legible and elaborate label in accordance with the requirements of Reg. European 1272/2008 – CLP.

I offer you support for a correct identification of the chemical, for identifying hazard indications, for defining the status of the product, we will identify any possible restrictions of your product for manufacturing, marketing, inside and outside the community.
We will develop a product label, establish hazard indications, appropriate pictograms, hazard phrases (H) and safety phrases (P), as well as all items to be labeled, including instructions for use for biocidal products.
We will indicate the types of packaging suitable for your product, incompatibilities with other products and any aspect related to them.
I offer support for the registration of the company on the ANPM portal, completing the database and transmitting the situation of the products that are subject to reporting, according to Reg. 1272/2008 – CLP in SIM (integrated environment system).

We elaborate the Safety Data Sheet according to the Annex to Regulation (EU) no. 830/2015 – REACH, Guide for drawing up Safety Data Sheets, for chemical substances and mixtures produced / marketed / used inside and outside the community; product classification according to Reg. 1272/2008 CLP, complete information on the safe use of the product.
We develop exposure scenarios – Annex to the Safety Data Sheet, based on the Chemical Safety Report (CSR) available in the REACH file.
We check and offer the updated Safety Data Sheet for the products in accordance with the last CLP Regulation requirements, aiming to be met: the classification and labeling criteria, the fully and correctly identified uses, the security measures applicable to the use of the product, the health information and safety at work, information on fire fighting measures, product incompatibilities in handling / transport / storage, packing criteria.

Preparation of safety data consultancy: 150 euro*

Document development support ISO 9001: 2015 quality management system
Development / revision of the SMC documentation according to the requirements of the standard EN ISO 9001: 2015, respectively system procedures, operational procedures, plans and related programs;
Modification of the SMC documentation in order to maintain and improve its effectiveness;
Internal audits of the SCM and elaboration of the audit report;
Technical support for corrections and corrective / preventive actions established through non-compliance reports, implementation of recommendations in the audit report;
Follow-up on the timely implementation of corrections and corrective / preventive actions and their effectiveness and, as the case may be, closing the non-compliance report or reopening (in case of non-fulfillment or ineffectiveness of the AC / P);
Preparation of audit reports;
Internal training of the persons involved in activities regarding the Quality Management System.

At the national level,in Romania, the information regarding the chemical mixtures must be entered in the Romanian National Register of Toxicological Information, called ReTox, obligation derived from Art. 45 of the Reg. (EC) 1272/2008 – regarding the classification, labeling, packaging of mixing substances – CLP
At European level, chemical mixtures will be introduced in the ECHA database, according to Art. 45 and Annex VIII to Reg. (EC) 1272/2008 –CLP, transposed by Reg. (EU) no. 542/2017 – harmonized information on the emergency response regarding health
Notification deadlines: January 1, 2020 for mixtures marketed to consumers; January 1, 2021 for mixtures marketed to professionals; January 1, 2024 for mixtures marketed to the industry
Services offered:
Solutions regarding the identification of mixtures eligible for notification in the RETOX register and in the ECHA (European Chemicals Agency) database – Poison Center
Support for notification of products in the RETOX register
Support for generating UFI numbers (unique identifier number) – ECHA requirement
Support for the re-labeling of chemical mixtures and the introduction of new information on labels
Solutions for developing PCN (poison center notification) dossiers in IUCLID 6 format
Registration on the ECHA platform in order to submitting the PCN dossier to the European Poison Center

Notification of chemical mixtures consultancy: 200 euro* / product