EU Transparency Regulation The EC issued a proposal for updated regulations during 2018, which was scrutinized during an open public discussion involving citizens, national authorities, and industry stakeholders. The industry leaders that took part were represented by a variety of sectors. This lead to an array of changes.
A new approach on the following 8 general regulatory acts to adhere to EU Transparency Regulation Which covers eight general regulatory acts that deal with the food, feed, and agri-cultural process chain to increase transparency in the risk evaluation process, touching upon the following areas:
The main objective of the EU Transparency Regulation, predominantly associated with:
What to expect coming March 27th The new Transparency Regulation was published on the 6th of September 2019.From the 27th of March 2021, the EU’s new Transparency Regulation will enter into force. The EFSA will require a compulsory pre-application submission notification for all studies to be performed by laboratories and potential applicants, including the title, scope, testing facility, starting and planned completion dates of the project.A potential applicant can ask for a pre-submission meeting as a consultation on the potential approval application. The commission and the EFSA systems will interact with all the domains impacted by the Transparency Regulation.
Clarity and transparency is the new norm and here is how The commission and FCO have cooperated to build a more coherent ecosystem that incorporates transparency requirements within the existing independent scientific evaluation process, the confidentiality assessment process and public dissemination are the foundations for this evolution in food and feed safety regulation. The EFSA will offer producers and stakeholders a (re)submission platform which will become the main gateway for the industry applicant to create and manage their food and feed-related dossiers.The benefit is in the manageability of the paperwork relating to the production process, meeting legislative needs and compliances. A database of all authorized studies by the industry will be accessible and controlled by the EFSA. All personal data will remain confidential except when it is firmly required to certify transparency. However, all non-classified studies and data supporting an application to be assessed by the EFSA are automatically made public when the submission is validated.
Laboratories the Transparency Regulation and ISO certifications
A large part of transparency for a laboratory is in the conveyance of the data, to the client or internal party requesting the information. It is therefore important all processes are met with a certain standard of consistency which substantiates the transparency needed to facilitate in the Transparency Regulation. Specifically, the ISO 17025 is of importance in regards to adhering to the standard for testing and calibration of equipment in the laboratory setting.The ISO/IEC 17025 facilitates laboratories to validate their competencies and generate legitimate and accurate findings. A large part in receiving the ISO 17025 is in the establishment of general company guidelines as found in the ISO 9001 for quality management, once these are established it will serve in the general transparency needed to adhere to European legislation in general.It similarly helps to enable collaboration amongst laboratories and other bodies such as the EFSA by producing broader recognition of outcomes between countries and the Member States. Test reports and certificates are accepted without the necessity of additional research.We, at Delft Solids Solutions, are currently working towards finalizing both the ISO 9001 and the ISO 17025, so we can serve our clients even better in terms of regulation, although we regularly pass our client’s audits and adhere to a rigorous internal process, convenience is also an important factor.
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How we can help you
With these new regulations comes a new need for clarity. Delft Solids Solutions helps with investigations that are performed in close consultation with you the customer and are performed under circumstances that closely match the targeted application of the product or the challenge faced during the production process. We are capable of offering these services because of our well-equipped specialized laboratory.Our experts investigate the results and provide an accurate report, offering clarity and context, the quality of the generated results is assured because we work in accordance with ISO 17025. All reporting of investigations is realized by developing a detailed research report. So what can you expect? The report will include background information on the methodology and equipment used in the investigation and is accompanied by a discussion of the generated results. Which will meet your Transparency Regulation needs.
In April of 2018, the European Citizens’ Initiative (ECI) requested an injunction with the European Commission in regards to the usage of glyphosate and protect people and the environment from toxic pesticides. Subsequently, the ECI called for greater transparency around the scientific studies used to support regulated substances in the food-related industries including feed and agricultural industries. This led the EC to perform a qualification Inspection to assess whether the regulatory framework at that time was fitting the aim.
The outcome of the inspection was the formulation of a new transparency regulation, Regulation (EU) 2019/1381. The new regulation amends the previous General Food Law of 2002.
