Over 25 years providing regulatory coverage to chemical companies in Europe. A team of professionals that turns regulatory requirements into a competitive advantage.
Facing an inspection or an urgent requirement? ServiREACH provides technical response for critical compliance situations.
The areas where ServiREACH concentrates its greatest technical capability and where chemical companies need us most.
We manage substance registration with ECHA, Lead Registrant roles within the SIEF, and the preparation of CSRs with exposure scenarios. We also carry out compliance audits to detect gaps before an inspection takes place.
We prevent the lack of a REACH registration number from halting the marketing of your product in Europe.
We prepare authorisation dossiers for biocidal products under Regulation (EU) 528/2012, manage procedures before ECHA and the competent authorities, and design the most efficient regulatory strategy.
A benchmark in BPR authorisations in Spain, with experience in disinfectant products of all kinds.
We classify mixtures and substances under the CLP/GHS Regulation, prepare safety data sheets (SDS), manage UFI codes and handle poison centre notifications in an automated way.
Our approach streamlines regulatory processes, reduces errors and ensures that documentation is always up to date with current legislation.
In addition to the cross-cutting regulations, ServiREACH works with specific legislation in the following industrial sectors.
Regulation (EU) 2019/1009. CE marking of fertilising products and registration strategy.
The most common pain points of companies in the chemical sector when they come to ServiREACH.
A leading hospital disinfection company needs to obtain BPR authorisation for a portfolio of critical products used in healthcare environments, with strict data requirements, specialised testing and complex risk assessments.
Result: Phased registration strategy deployed. First import cleared in under 2 months and registration completed within the appropriate annual tonnage band in under 3 months.
A company needs to release a key chemical substance for its production from customs. The substance is not registered under REACH in Europe and no other operator in the supply chain has registered it previously.
Result: Phased registration strategy deployed. First import cleared in under 2 months and registration completed within the appropriate annual tonnage band in under 3 months.
A company receives an inspection notice regarding its REACH and CLP obligations, with potential detection of non-compliance and penalties if it fails to respond adequately.
Result: Regulatory situation reviewed, potential non-compliance issues rectified and a sound technical response to the inspection prepared. Risk of penalties avoided.
Chemical regulatory consultancy helps companies comply with the European regulations governing the manufacture, import, classification and marketing of chemical substances and mixtures. You need it when your company markets products affected by these regulations, when you manufacture or import substances in volumes that require REACH registration, when you market biocidal or cosmetic products, or when you receive requirements within the supply chain or from the competent authorities. In general, any company marketing substances, chemical mixtures or articles (everything that is not a substance or mixture) on the European market has regulatory obligations to fulfil.
They are two different regulatory obligations, arising from two separate Regulations. REACH registration (Regulation EC 1907/2006) is mandatory for European manufacturers and importers of chemical substances in volumes above 1 tonne per year, and its fundamental purpose is to demonstrate the safe use of the substance. BPR authorisation (Regulation EU 528/2012) is a specific obligation for biocidal products (disinfectants, pesticides, insecticides, repellents, preservatives, etc.) and regulates their marketing in the European Union. The same company may have obligations under both regulations at the same time.
In Spain, infringements of the REACH or BPR Regulations are penalised under Law 8/2010 on the sanctioning regime for chemical products. Fines range from €3,000 for minor infringements to €600,000 or more for very serious ones, and may include suspension of activity or withdrawal of the product from the market. In addition, a history of non-compliance can affect future authorisations. ServiREACH offers an emergency technical response in official inspection situations.
The classification of any product depends on its main function and on the claims the manufacturer makes on the labelling and in advertising. For example, a hydroalcoholic gel presented as a hand sanitiser may be considered a cosmetic (if it does not claim to eliminate or neutralise microorganisms), a biocide (if it claims disinfection) or both, depending on the applicable regulatory framework. This distinction has direct consequences for registration requirements, the necessary testing and time to market. A prior consultation with ServiREACH can prevent classification errors that could lead to severe consequences.
Send us your case and we will respond with technicaexpertl feedback and a tailored service proposal.
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