News http://chemikalia.gov.pl Fri, 19 Jun 2020 10:30:05 +0200 http://backend.userland.com/rss092 pl BREXIT and export of hazardous chemicals (regulation 649/2012) Pursuant to Article 8(2) of Regulation (EU) No 649/2012 on the export and import of hazardous chemicals, exporters are required to notify their exports 35 days before the expected date of export. In order to cover exports taking place in the first 35 days from the withdrawal date if there is no withdrawal agreement, a temporary procedure has been made available, which allows EU27-based exporters to notify the planned export to the United Kingdom in advance of the withdrawal date. These export notifications will take effect if the United Kingdom is, as of the withdrawal date, a third country without a withdrawal agreement entering into force on that date. The temporary procedure is to be carried out outside the ePIC application until the modalities of the UK’s withdrawal from the EU are known.

ECHA has published an export notification form together with instructions on its website to facilitate the process. The workflow is described below:
- The exporter downloads the export notification form available on ECHA’s website, fills-it in and forwards it together with the associated SDS, as appropriate, to his Designated National Authority (DNA) by email.
- The DNA verifies the compliance of the notification and sends it to ECHA by email using the following address: pic@echa.europa.eu.
- ECHA verifies the compliance, assigns a provisional identification number to the notification and forwards it to the UK DNA by email.
- ECHA communicates the provisional identification number to the exporter and the DNA.

Once the modalities of the UK’s withdrawal from the EU are known, the procedure will be adapted accordingly. If appropriate, a new release of ePIC will be made available, which will allow submissions to the UK under the standard export notification procedure via ePIC.

Depending on the modalities of the UK’s withdrawal from the EU, ECHA may contact those companies, who have submitted a manual notification of exports to the UK and request the notification of those exports within the ePIC application. The following should be noted:

- The provisional identification number received after the manual notification should be inserted in the message field upon submission of the notification in ePIC.
- As it is not possible to specify in ePIC an expected date of export earlier than 35 days from the submission date, ECHA will activate the export notification (i.e. allow the export to take place) from the export date provided in the manual notification.
 

]]> http://www.chemikalia.gov.pl/news.html?news_id=1958 Fri, 22 Mar 2019 11:40:02 +0100 13th OECD training course for Good Laboratory Practice inspectors On October 2-5, 2017 in Cracow (Poland), the 13th OECD training course for Good Laboratory Practice inspectors was held. This course was hosted by Bureau for Chemical Substances – the Polish GLP Monitoring Authority - under the auspices of the OECD GLP Working Group. Over 80 GLP inspectors from 36 countries attended the course. The purpose of the courses for GLP inspectors, organized every two years, is to exchange experiences and to help to expand knowledge of the GLP requirements.Opening ceremony of the course was made by Mr. Zbigniew J. Król - Undersecretary of State in the Ministry of Health, Mr. Sigman - Head of the OECD GLP and Pesticides Programmes, Mr. Hitoshi Someya - Chairman of the OECD GLP Working Group and Ms. Agnieszka Dudra - Inspector for Chemical Substances.

The Good Laboratory Practice (GLP) is a quality system concerning the organisational process and the conditions of planning, conducting and monitoring non-clinical studies of substances and their mixtures in terms of their safety to human health and the natural environment, and recording, archiving and reporting their results. The principles of Good Laboratory Practice are applied in non-clinical studies on safety of medicinal products, veterinary drugs, plant protection products, cosmetic products, biocidal products, food additives, feed additives, detergents and chemicals used in industry, servics and households. The studies covered by the principles of Good Laboratory practice include studies conducted in laboratories, in greenhouses and in the field.

In the Republic of Poland, under the provisions of the Article 16(3) of the Actof 25 February 2011 on the chemical substances and their mixtures (Journal of Laws of the Republic of Poland of 2015 item 1203, 2016 item 2003), Bureau for Chemical Substances is a competent authority for the inspection and verification of compliance with the principles of Good Laboratory Practice by the test facilities or certified test facilities.

The course in Poland was organized as an advanced training course for GLP inspectors. The course consisted of lectures and workshops. The workshops focused on: 

- practical aspects of a GLP inspection,

-  inspecting the computerized systems during GLP inspection,

-  practical aspects of non-compliance decisions and non-compliance repots.

 

More information on the course you will find on the website: http://13glpoecd.pl/

]]> http://www.chemikalia.gov.pl/news.html?news_id=1829 Thu, 19 Oct 2017 08:14:03 +0200 The European Commission is looking for experts The European Commission is looking for experts to join a newly established independent advisory panel assisting Member States and the Commission in determining whether tobacco products have a characterising flavour.
More details HERE
]]> http://www.chemikalia.gov.pl/news.html?news_id=1720 Tue, 26 Jul 2016 13:35:43 +0200 Commission implementing decisions 2016/786 and 2016/787 of 18 May 2016 European Commission published two new decisions: 
What is more, European Commission published regulation laying down uniform rules as regards the procedures for determining whether a tobacco product has a characterising flavour and report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes.
]]> http://www.chemikalia.gov.pl/news.html?news_id=1708 Tue, 24 May 2016 14:11:21 +0200 Start of applying for a Submitter ID in the tobacco industry European Commission presented step by step how to apply for a Submitter ID. 
Firstly, you should create an ECAS account . This step is mandatory for submitters who intend to use the standalone application. ECAS is the European Commission Authentication Service. It allows users to access a wide range of Commission information systems, using a single username and password. 
 
 

Then in order to apply for a Submitter ID, please follow the following steps:

  1. download the registration form (use Internet Explorer web browser);
  2. read carefully the instructions contained in the registration form;
  3. complete the registration form;
  4. submit the registration form.
Upon receipt of a completed request form, the Commission will begin the process of assigning a Submitter ID. The Commission reserves the right to revert to applicants should additional information be required, to withhold Submitter IDs pending further verification and to withdraw previously assigned Submitter IDs, should it deem necessary. What is more, the Commission will endeavour to complete the assignment process within as short a timeframe as possible. Please note, however, that the assignment of a Submitter ID does not take place instantaneously upon receipt of the form and that during peak requesting periods, additional processing time up to several days may be required. Please bear this in mind when submitting your request forms.
 
Once a Submitter ID has been acquired, there will be two possible means of submitting reporting information to Member States via the EU-CEG:
  1. via a Client/Stand-Alone application (suitable for companies with smaller IT infrastructures). This is currently being developed by the Commission and will be made available to companies free of charge.
  2. system-to-system submissions (suitable for companies with larger IT infrastructures). Companies making system-to-system submissions will need to ensure access to the e-Delivery network, which is a network operated by the Commission and ensuring secure and reliable information transfer. More information you can find below:

 

Commission’s Contacts 
  • Should you encounter technical difficulties when requesting a Submitter ID, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a 'print screen' of the window where the problem appears and a copy of your registration form).
  • For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu.
All information above you can also find:
http://ec.europa.eu/health/euceg/#fragment0
http://ec.europa.eu/health/euceg/#fragment1
 

]]> http://www.chemikalia.gov.pl/news.html?news_id=1705 Wed, 04 May 2016 10:15:29 +0200 The draft act amending the act on the protection of health from the effects of the use of tobacco and tobacco products On 19 April 2016 the draft act amending the act on the protection of health from the effects of the use of tobacco and tobacco products was referred to the Sejm.

http://www.sejm.gov.pl/sejm8.nsf/agent.xsp?symbol=RPL&Id=RM-10-24-16

]]> http://www.chemikalia.gov.pl/news.html?news_id=1703 Thu, 21 Apr 2016 09:58:59 +0200 EU Common Entry Gate for reporting of information on tobacco products and notification of information on electronic cigarettes and refill containers There is a possibility to test the notification platform, but at the moment only for companies, which have a proper IT infrastructure. The rest of companies will be able to take part in the next turn of testing. 
Moreover, there is an open access to European Commission Authentication Service (ECAS). Manufacturers and importers will need to create and ECAS account. It is the first step to receive ID number by submitter. More information can be found on websites below:
Below it is shown how to get an access to test the notification platform (for companies with proper IT infrastructure):
To initiate the process of connectivity testing between your AS4 gateway and the EU-CEG AS4 test gateway in the context of the EU-CEG project, send the information in the below format to the CEF Support team.
 
Subject: AS4 Connectivity test for EU-CEG project
 
Hello,
I am person X from company Y.
I am contacting you in the context of the AS4 connectivity tests for the EU-CEG project.
Please find my requested details below and provide me the information needed to perform the setup at my side.
What is more, we encourage all the producers and importers of tobacco products and related products to follow the website below, where you can find a lot of documents concerning tobacco directive, for example: warning messages on tobacco packages or format for submission of data on ingredients. 
http://ec.europa.eu/health/tobacco/key_documents/index_en.htm#anchor0
]]> http://www.chemikalia.gov.pl/news.html?news_id=1692 Fri, 18 Mar 2016 09:39:26 +0100 Keep caps from kids Bureau for Chemical Substances joint awareness raising campaign: “Keep caps from kids”.

The main goal of this detergent industry initiative  is to promote the safe storage and use of liquid laundry detergent capsules.

  For more information please visit http://www.keepcapsfromkids.eu/uk. 

]]> http://www.chemikalia.gov.pl/news.html?news_id=1643 Fri, 12 Dec 2014 13:11:39 +0100 ECHA Committees support 16 uses of substances of very high concern https://www.chemikalia.gov.pl/img/48b2145e_large.jpg

ECHA Committees support 16 uses of substances of very high concern

Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have issued opinions in support of authorising the use of substances of very high concern (SVHCs). The opinions are based on eight applications for 16 specific uses.

More information

]]> http://www.chemikalia.gov.pl/news.html?news_id=1636 Fri, 26 Sep 2014 14:44:38 +0200 RAC concludes on scientific opinions for CLH

RAC concludes on scientific opinions for CLH

The Committee for Risk Assessment (RAC) adopted five opinions for harmonised classification and labelling (CLH).

The RAC opinions, all agreed by consensus, concern the following substances:

  • Methanol
  • Chloralose
  • N,N dimethylacetamide (DMAC)
  • Iodomethane
  • Heptadecafluorononanoic acid and its sodium and ammonium salts (PFNA).

News alert

]]> http://www.chemikalia.gov.pl/news.html?news_id=1635 Fri, 26 Sep 2014 14:40:27 +0200