Your challenge – our solution
We have the experience and knowledge to take care of your REACH regulatory needs. Over more than two decades, we have prepared more than 100 notifications for new chemical substances. Several hundred registrations for substances and intermediates under REACH have been already filed by us. Furthermore, we have established a network to ECHA and national competent authorities as well as to industry associations and organizations (e.g. CEFIC) and are recognized as a reliable and competent partner. We know how to deal with different REACH IT Tools, IUCLID6-dossier preparation and risk assessment (Chesar, EASYTRA and more specific models, e.g. ConsExpo), including intelligent testing strategies, read-across, data bridging, category approaches, PBT/vPvB assessment, etc.
A short list of services that we can provide to you:
- Only Representative and Third Party Representative support
- Consortia management
- Late pre-registration
- Portfolio analysis, data review/valuation and data gap analysis
- Overall REACH strategy including intelligent testing strategies
- Study planning and monitoring
- Compilation of IUCLID-dossiers Chemical Safety assessments and Chemical Safety Reports
- Classification and labelling incl. CLH dossiers and support in the RAC
- Submission and defence of registration dossiers at member state (CoRAP) and ECHA level
- Review of existing safety data sheets and extended safety data sheets (eSDS)
Your challenge
The modern global pesticides regulatory environment is defined by a vast number of national and international regulations and policy conventions. Now more than ever, the development of pesticide regulations is being driven by increasing demand for human health and safety, and environmental sustainability. Despite this trend, standards in different parts of the world still vary enormously, shaped by the economic development, political objectives and agricultural strategy of individual nations and regions. As a result, it is a challenge for the industry to keep pace with the constantly changing regulatory frameworks in their target markets.Our solution
Starting with the European pesticide regulations back in 1989, we gained an excellent reputation over the years for our in-depth expertise in the EU. Building on this professional know-how, we went further, broadening our focus to include non-EU markets. In recent years, we have been working hard to establish an international network of partners; we have been educating our staff and acquiring hands-on experience of regulatory requirements by working on registration projects in Asia and North America.Supported by our partners, we continuously monitor the latest developments in agrochemical and biopesticide regulations across global key pesticide markets. We offer our customers a broad scope of services tailored to their registration needs both within and outside of the EU.
For further information on available services please refer to the subordinated sites of our Agrochemicals and Biorationals business unit, or
Regulatory Support for Consumer Products
For more than two decades, we have been offering regulatory services to the consumer goods industry. We have successfully dealt with all relevant scientific and regulatory aspects or problems that may arise for general and overall evaluation of materials or chemicals for intended applications.
Our Expertise
Our expertise extends from ensuring compliance with the broad requirements of the EU General Product Safety Directive (GPSD, 2001/95/EC) to helping you meet sector-specific challenges, such as those arising from the EU Detergents Regulation (EC No. 648/2004) and its amendments.
Your Advantage
One of the key advantages for our clients is our in-depth knowledge of all relevant national, European and global regulations. We have a wide-spread network in both, the industry including its associations, and the governmental world.
Our Services
We usually start with an analysis of the individual needs of our clients before we focus on specific tasks, such as:
- Detailed data gap analysis
- Safety assessment of ingredients and products; creation of comprehensive toxicology and ecotoxicology profiles, environmental behaviour
- Expert advice on testing strategies and study placement and monitoring at proven contract research organisation partners
- Safety and risk assessments covering appropriate exposure scenarios
- Advice on classification, claims and labelling
- Preparation of safety reports, dossiers up to notifications
Your challenge – our solution
We have the experience and knowledge to take care of your chemical regulation needs, both inside and outside the EU.
Starting well before the implementation of REACH, we have prepared more than 100 notifications for the registration of new chemical substances in the EU. Since REACH came into force in 2007, we have prepared more than 600 additional lead dossiers for phase-in and non-phase-in substances. Through our office in Japan and our network of partners, we can also effectively support our clients in key markets in East Asia & Pacific as well as in the US and Canada.
We maintain an extensive network of contacts with European (ECHA and national competent authorities) and international authorities as well as with industry organizations and are widely recognized as a reliable and competent partner.
Your challenge
Changes in the agricultural sector are reflected by recent agricultural legislation in the European Union, such as Regulation 1107/2009 or new data requirements (Regulations 283/2013 and 284/2013). In accordance with the Common Agricultural Policy (CAP), the Sustainable Use Directive (2009/128/EC) established a framework for Integrated Pest Management (IPM) as well as for the future use of agrochemicals and biopesticides. Other EU priority areas including water management and use, rural development or organic farming, diversify the requirements for registration of agrochemicals and biopesticides even further.
Our solution
Since 1989, our Agrochemicals and Biopesticides Business Unit has submitted numerous dossiers e.g. according to Commission Directive 91/414/EEC, along with many applications for national registration in EU member states. Our experience is your advantage! Be it for the re-authorisation of your products with the new dRR format or the zonal application system according to Regulation 1107/2009 for plant protection products. We are familiar with all types of conventional and biological pesticides and other agrochemicals such as fertilizers for professional and amateur use.
Current and future regulatory and legislative needs and developments in the common agricultural policy of the EU are considered by us and we stay up-to-date on the latest scientific research data. For this reason, our Business Unit is at the forefront in strategic planning and defence, negotiations with authorities, or task force leadership.
Take advantage of our long-standing experience and let us take care of your agrochemicals and biopesticides registrations, regardless if your corporate structure is a small- or medium-sized enterprise, or a multinational company.
For further information on available services please refer to the subordinated sites of our Agrochemicals and Biopesticides Business Unit, the site for our Regulatory Science Business Unit, or contact us directly.
Regulation of Biocides in the EU
The first milestone in the European history of biocides regulation was set with the Biocidal Products Directive 98/8/EC (BPD) adopted in February 1998 and aiming at harmonising the EU market for biocidal products and their active substances, while ensuring a high level of protection of the environment, human and animal health. Biocides are divided into diverse product types, including disinfectants, preservatives, pest control, anti-fouling and embalming products.
In September 2013, the BPD was replaced by the Biocidal Products Regulation No 528/2012 (BPR) concerning the making available on the market and use of biocidal products. Among major revisions brought forward in the BPR was the introduction of the possibility to authorise certain biocidal products and product families at Union level by means of the so-called union authorisation or mutual recognition. The latter is applicable for companies wishing to extend their national product authorisation to other markets within the EU. The BPR also lays down the provisions for the renewal of already approved active substances and regulates the use of articles treated with or intentionally incorporating biocidal products.
With the authorisation process of biocidal products being regulated at EU Member State level, excluding union authorisation, the lack of harmonisation of mutual recognition procedures within individual Member States still poses a challenge to the biocides companies authorising their products in the EU. SCC experts can guide you through the regulatory challenges of the biocidal authorisation process.
Our Expertise
Established in 2000, our Biocides team of experts have successfully submitted dossiers for more than 25 existing biocidal active substances, covering nearly all product types. We have established excellent working relationships with many competent authorities in the EU and have become an acknowledged partner of authorities and industry.
Besides a broad spectrum of services, our special focus currently lies in defending active substance dossiers already submitted and preparing dossiers for biocidal products.