Desmond Waight outlines the requirements of the European Union’s (EU’s) PIC Regulation and its application to the export of any hazardous chemical (as per Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)) or dangerous preparation (as per 1999/45/EC Dangerous Preparations Directive (DPD)).
The “PIC Regulation” — or the Prior Informed Consent Regulation — is now considered as an unofficial reference to the Regulation (EU) No. 649/2012, of the European Parliament and of the Council, of 4 July 2012 concerning the export and import of hazardous chemicals.
Although made in 2012, the regulation did not start to apply until 1 March 2014, when it repealed the former PIC Regulation (EC) No. 689/2008. Note: it is important, when referring to the PIC Regulation, to clarify which of the two versions is being referred to.
Aims of the regulation
The aims of Regulation (EU) No. 649/2012 were to:
recast the former PIC Regulation (EC) No. 689/2008, which had been subject to a number of amendments, and thus continue to:
implement the requirements of the, so-called Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
promote shared responsibility and co-operative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm
contribute to the environmentally sound use of hazardous chemicals
align terminology with the Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), for clarity and consistency
to transfer certain responsibilities to the European Chemicals Agency (ECHA), from the Commission’s Joint Research Centre (JRC)
update the earlier regulation to reflect the new CLP Regulation requirements.
The regulation applies to:
certain hazardous chemicals that are subject to PIC procedures under the Rotterdam Convention
certain hazardous chemicals that are banned or severely restricted within the EU or a Member State (MS)
any chemical that is exported, in so far as its classification and labelling (C&L), packaging, and Safety Data Sheet (SDS) provisions are concerned (imports, C&L and SDS provisions being covered by the duties placed on importers by the CLP Regulation).
The regulation does not apply to:
narcotic drugs and psychotropic substances as per Regulation (EC) No. 111/2005
radioactive materials and substances as per Directive 96/29/Euratom
wastes as per Directive 2008/98/EC
chemical weapons as per Regulation (EC) No. 428/2009
food and food additives per Regulation (EC) No. 882/2004
feedingstuffs as per Regulation (EC) No. 178/2002
genetically modified organisms as per Directive 2001/18/EC
most proprietary medicinal products and veterinary medicinal products as per Directives 2001/83/EC and 2001/82/EC.
Also exempted are chemicals exported for the purchase of research or analysis in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10kg from each exporter to each importing country per calendar year.
Since 1 March 2014, the ECHA has been responsible for the administrative and technical tasks related to the PIC Regulation.
The Agency's main task will be to process and send export notifications to the importing countries outside the EU, and keep a database of the notifications and the explicit consents given by the importing countries.
The ECHA will also provide assistance as well as technical and scientific guidance to industry and the designated national authorities (both from the EU, third countries and the European Commission).
The ECHA shall also:
maintain, further develop, and readily update, a database on the export and import of hazardous chemicals
make the database publicly available on its website.
Enforcement of the regulation remains the responsibility of the applicable MS. In the UK, this is enforced, in consequence of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (BPC), as if the PIC Regulation were health and safety regulations made under the Health and Safety at Work, etc Act 1974.
Requirements for exported chemicals
Due to the short title use for this regulation, many are unaware of its applicability to any hazardous or dangerous chemicals exported (except as specifically exempted as noted earlier).
Article 17(1) requires that chemicals intended for export from the EU shall be subject to the provisions for packaging and labelling (and although it is not expressly mentioned, it also extends to classification where applicable) of the provisions that would apply to those chemicals if supplied within the EU. These provisions are:
Regulation (EC) No 1107/2009 on Plant Protection Products
Directive 98/8/EC on Biocidal Products (but see below)
CLP Regulation (EC) No 1272/2008, or
any other relevant EU legislation including:
the requirements of the 1999/45/EC Dangerous Preparations Directive (DPD), until 1 June 2015
the Biocidal Products Regulation (EU) 528/2012 (see above).
However, this is provided that the EU packaging and labelling does not conflict with any specific requirements of the importing country, in which case those provisions would take precedence.
Where appropriate, the labelling shall also include the expiry date and production date of the hazardous/dangerous chemical (or those chemicals listed in Annex I of the regulation, regardless of whether hazardous/dangerous). The expiry date shall reflect the differing climatic conditions compared to the EU. Chemicals exported shall have at least six months’ life before the quoted expiry date.
There are additional requirements for pesticides exported.
The labelling is subject to language requirements, as set out below.
Article 17(3) requires that a REACH-compliant SDS shall accompany any hazardous/dangerous chemical when exported. It also requires that the SDS shall be sent to each natural or legal person in the country importing the chemical.
The SDS is subject to language requirements, as set out below.
Article 17(4) states that the information on the label and in the SDSs shall “as far as practicable, be given in the official languages, or in one or more of the principal languages, of the country of destination or the area of intended use”.
Here it should be noted that there is no qualification of the word “practicable” by the word “reasonably”, so that a cost benefit analysis approach cannot be applied to the decision.
Note: The HSE website on the PIC Regulation notes that “there are many widely available sources of information on commonly used languages. Standard internet searching of destination country languages will usually identify appropriate sources of information”. Help on the languages that may be appropriate is also given in technical guidance that was published in support of the earlier PIC Regulation (EC) 689/2008, and which is largely applicable as support to the newer PIC Regulation (EU) No. 649/2012.
Updating the regulation
As with all EU regulations, the PIC Regulation is subject to amendment to keep it up-to-date in relation to changes in the Rotterdam Convention.
By some clever wording, however, certain amendments to the former PIC Regulation (EC) No. 689/2008 are deemed to be amendments to the new PIC Regulation. These are Commission Regulations (EU) No. 73/2013 and Commission Regulation (EU) No. 167/2014.
You should be able to track the changes on the EUR-Lex website, but this does not yet show the amendments to the former PIC Regulation (EC) No. 689/2008 that are also applicable to this later PIC Regulation (No. 649/2012).
However, any updates to the regulation will only affect the lists of chemicals subject to the specific prior informed consent procedures, and will not amend the general requirement for classification, packaging, labelling and SDS provision.
Those companies exporting chemicals who believe that the requirements under CLP and REACH do not apply to them, need to understand how the PIC Regulation applies to them, and requires classification, packaging and labelling on SDSs to be provided to the standards that would be applicable within the EU, but in languages suited to the recipients in the countries to which the products are exported.