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Guide for translation of the Summary of Product Characteristics SPC

Contents:

This information concerning the translation of the SPC into Swedish is meant for companies that have an ongoing application or are planning to apply for the authorization of a biocidal product in the Swedish market.

Introduction

A Summary of Product Characteristics (SPC) is an essential part of a biocidal product authorization. It contains important information about the biocidal product to be put on the market. In Sweden the SPC is required to be in Swedish.

The SPC is a description of the characteristics of the biocidal product. It contains for example, administrative information, the classification and labelling of the product, its composition, the authorized uses including target organisms, application methods and packaging and the directions of use. In Sweden the SPC is required to be in Swedish, according to the Biocidal Products Regulation (EU) 528/2012 External link..

During the evaluation process of a biocidal product, the information in the SPC is carefully analyzed and must be agreed upon together with the other Member States before the product will reach different markets in Europe.

ECHA has published general recommendations on how to prepare a SPC titled Recommendations on preparing a Summary of Product Characteristics (SPC) for single biocidal products and biocidal product families External link..

How to translate your SPC into Swedish

A Swedish translation of the SPC - good quality from the beginning

It is important that you provide us with a SPC that has been translated into Swedish based on the agreed English SPC. In order to help you with the Swedish translation of the SPC, we suggest you follow the guide below.

  • Open the SPC Editor External link.. This is a tool from ECHA to create and edit SPC documents.
  • In SPC Editor choose the Swedish market area and start creating the Swedish version of the SPC.
Instructional screenshot: Step 1. Choose menu New. Step 2. Choose menu item Market area version.
  • Translate into Swedish all information including headers. Make sure that the correct Swedish name of the product is written in the SPC, including tradenames.
  • Avoid using Google Translate or any on-line translators. Keep in mind that the SPC may contain technical language that the translators on-line most probably will translate wrong.
  • ECHA continuously updates a document containing commonly used sentences in SPCs and their translations in different languages, including Swedish. Check if the sentences you want to translate into Swedish are already included in the document External link..
  • Always translate into Swedish the common names of the target organisms and their development stage. If you are not sure about the Swedish name of a specific target organism, you can consult the webpage artfakta.se/artbestamning External link.. Observe that in the search engine you can introduce the name of a target organisms in Latin and the system will render the name of the organism in Swedish together with its picture.
  • In SPC Editor there are several fields with picklists where you can choose a word or sentence. Observe that even when you choose the Swedish market area, these picklists will still contain information in English. If you do not find the right word or sentence for your SPC, enter the Swedish name manually in the text field "Svenskt namn".
Instructional screensshot: Alternative 1:Choose a word or sentence from the picklist for Swedish name, Svenskt namn.
Instrucctional screenshot: Alternative 2: Type the Swedish name manually.
Last published 19 December 2022