Environmental Risks

Chemical substances and products

The "Chemical substances and products" fact sheet provides information on the substances made available on the European market, in view of the processes associated with implementing the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Additionally, this sheet records the number of chemicals exported and imported from and to Portugal as part of the Regulation on the Prior Informed Consent (PIC).
Description: 

Certain chemicals, namely the ones which consist of substances of very high concern, such as carcinogenic substances, mutagenic substances or substances toxic to reproduction, that have PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative) properties, may have a negative impact on human health and the environment, so their manufacturing, placing on the market and use must be subject to specific requirements.

The REACH Regulation lays down the provisions applicable to the manufacturing, placing on the market or use of chemicals in order to protect citizens and the environment, while strengthening the European industry competitiveness and innovation.

In this context, REACH determines that the European manufacturers or importers of substances must register them at the  European Chemicals Agency (ECHA), from the moment that their activities involve quantities above 1 tonne per year. Ensuring compliance with this procedure is essential for manufacturing and/or importing the substances in question in and to the European Union (EU). If a substance is not registered, there will be no information available and, subsequently, the interested economic operator will not be allowed to manufacture it or market it within the EU.

The registration phase has several stages:

  1. All substances manufactured or imported in quantities over 1000 tonnes/year and substances classified as carcinogens, mutagens or toxic to reproduction over one tonne/year, as well as substances classified as very toxic to aquatic organisms, liable to cause long-term adverse effects on the environment, in quantities greater than 100 tonnes/year, were registered by 30 November 2010;
  2. Substances manufactured or imported in quantities between 100 tonnes/year and 1000 tonnes/year were registered by 31 May 2013;
  3. Substances manufactured or imported in quantities greater than 1 tonne/year must be registered by 31 May 2018.

The information collected during the registration process is essential for properly assessing the risks associated with the manufacturing and use of these substances and for identifying appropriate risk management measures, namely harmonised classification and labelling, authorisation or restriction.

Substances classified as carcinogens, mutagens or toxic to reproduction, that have PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative) properties, or that cause an equivalent level of concern, are identified as "substances of very high concern" and included in the "candidate list of substances for authorisation". This process is aimed at ensuring that the associated risks are adequately controlled and that these substances are gradually replaced with alternative substances or technologies, provided these are economically and technically viable.

From these substances, there is a selection of those that can only be manufactured and used with an authorisation granted by the European Commission, based on a risk assessment and on a socio-economic analysis. Should a substance pose an unacceptable risk to human health or the environment, arising from its manufacturing, use or placing on the market, and call for a Community-wide approach, it may be subject to restriction.

Simultaneously, the  Regulation on the Prior Informed Consent regulates the import and export of certain hazardous chemicals, implementing the Rotterdam Convention. The objective of the PIC is to promote the shared responsibility and cooperation in the international trade of hazardous chemicals and to protect human health and the environment, providing developing countries with information on the chemicals in question, in order to support their safe use. In this context, a company based in the EU will only be able to export these products upon the presentation of an export notification, and a preliminary favourable decision from the importing country may also be necessary.

These mechanisms help to increase the knowledge about the chemicals used in Europe, ensuring their safe use and promoting their replacement with alternatives that result in less pressures on human health and the environment.

This fact sheet concerns mainland Portugal and the Autonomous Regions of Madeira and the Azores and shall be updated on an annual basis.

Objectives and targets: 
  • Ensuring a high level of protection of human health and the environment in the use and manufacturing of chemicals, by: increasing knowledge about the substances placed on the European Union market; implementing appropriate risk management measures at the EU level; knowledge and informed consent on the import of products banned or restricted within the EU. 
  • Promoting the development of alternative methods for assessing the hazards of substances.
  • Strengthening competitiveness and innovation.
  • Ensuring the free movement of substances in the EU's internal market.
Progress analysis:

Registration dossiers submitted to ECHA for the 2010, 2013, 2018 registration deadlines and total registrations 

  EUROPEAN UNION Portugal
YEAR

 2010 DEADLINE 

  2013 DEADLINE 2018 DEADLINE Total  2010 DEADLINE 2013 DEADLINE  2018 DEADLINE Total
REGISTRATIONS 20,723 9,030 32,515 86,686 217 28 62 395
REGISTERED SUBSTANCES  * 2,998 10,708 24,328 * * 61 380

Note: * Data not available

Source: ECHA, April 2019

At the European level, more than 24,000 substances were registered until April 2019, totalling more than 86,000 registrations, thus representing a substantial increase in the knowledge regarding these substances, which had already been placed on the market.

About 380 substances were registered in Portugal, representing 1.6% of the total substances registered at ECHA.

In the 1st registration phase, Portugal submitted a total of 217 registrations (corresponding to 1.0% of the total of registrations submitted at the EU level, 20,723) while, in the 2nd phase, the companies based in Portugal submitted only 0.3% (28 registrations) of the total registrations submitted to ECHA, 9,030.

In the 3rd registration phase, which ended in May 2018, 10,708 new substances were registered. This number is significantly higher than in March 2018 (7,900 substances) and provides a full picture of the chemicals used in Europe, which will allow us to develop into an increasingly safer environment.

No. of substances of very high concern included in the candidate list of substances for authorisation

Notas: p - Provisional data
Source: ECHA, March 2018

Substances identified as substances of very high concern are included in the candidate list of substances for authorisation. The inclusion of substances in this list began in 2008, covering 197 substances until April 2019. 2012 was the year with the highest number of inclusions - 67 substances. In 2016, only 1 substance was included on the candidate list which increased slightly in 2017 and 2018, with 17 substances being added to the list in 2018.

The list of substances subject to authorisation includes, as of April 2019, a total of 43 entries (some of which are groups of substances). The last amendment to this list occurred in June 2017, with the inclusion of 12 entries.

In February 2019, the list of substances/group of substances subject to restriction contained a total of 69 entries, and 5 entries have been deleted to date. During 2018, 3 new entries were included and 2 of the existing entries were amended.

No. of chemicals exported and imported from and to Portugal as part of the Rotterdam Convention (PIC Regulation), per year

YEAR 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2019
No. Exported Chemicals 0 0 1 1 4 3 0 4 5 8 6
No. Destination Countries 0 0 4 2 14 2 0 10 10 10 10
No. Imported Chemicals 1 1 2 3 4 4 5 4 5 2 1
No. Portuguese Importing Companies 1 1 2 2 2 1 2 2 1 1 1

Source: APA, April 2019

With regard to Portuguese exports, the number of exported chemicals covered by the PIC Regulation shows moderate growth until 2012, having decreased since then, and until 2014, when no chemicals were exported. The export numbers rose again, in 2015, 2016 and 2017. In 2019 there was a reduction from 8 to 6 exported chemicals.

The number of imported chemicals increased until 2014, and has remained stable in 2015 and 2016. In 2017 a reduction of these values was observed, passing from 5 imported chemicals in 2016 to only 2. In 2019, there was again a reduction of imported chemicals, to a mere 1.

Last update: 
Thursday, 18 April, 2019
More information at: 

Portuguese Environment Agency – www.apambiente.pt
European Chemicals Agency (ECHA) – echa.europa.eu